FACE for Children With Rare Diseases

Palliative Care Needs of Children With Rare Diseases and Their Families

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04855734

Acronym

FACE-Rare

Enrollment

Registered

2021-04-22

Start date

2021-07-06

Completion date

2024-06-01

Last updated

2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rare Diseases

Keywords

palliative care, psychosocial interventions, rare diseases, family interventions, family-centered care, patient-centered care, pediatrics, adolescent, end-of-life care, public health, mental health, spirituality, children with rare diseases, behavioral interventions, decisional burden, role stress, family caregiver, person-centered care, chronic conditions, complex health needs, caregiver burden, respecting choices, evidence-based practice, randomized clinical trial (RCT), anxiety

Brief summary

Children with ultra-rare or complex rare diseases are routinely excluded from research studies because of their conditions, creating a health disparity. However, new statistical techniques make it possible to study small samples of heterogeneous populations. We propose to study the palliative care needs of family caregivers of children with ultra-rare diseases and to pilot test a palliative care needs assessment and advance care planning intervention to facilitate discussions about the future medical care choices families are likely to be asked to make for their child.

Detailed description

A rare disease is a condition affecting fewer than 200,000 persons. Pediatric patients with rare diseases experience high mortality with 30% not living to see their 5th birthday. Families are likely to be asked to make complex medical decisions for their child. Pediatric advance care planning involves preparation and skill development to help make future medical care choices. Children with rare disorders are a heterogeneous group often with co-morbidities, resulting in their exclusion from research, thereby creating a health disparity for this vulnerable population. Available research on families of children with rare diseases lacks scientific rigor. Although desperately needed, there are few empirically validated interventions to address these issues. We propose to close a gap in our knowledge of families' needs for support in a heterogeneous group of children with rare diseases; and to test an advance care planning intervention. The FAmily CEntered (FACE) pediatric advance care planning intervention, proven successful with cancer and HIV, is adapted to families with children who have rare diseases. Theoretically informed and developed by the PI, Dr. Lyon, and colleagues, the proposed intervention will use Respecting Choices Next Steps Pediatric Advance Care Planning™ for families whose child is unable to participate in health care decision-making. Our consultation with families of children with rare disorders and the National Organization for Rare Disorders (NORD) revealed that basic palliative care needs should be addressed first, before an advance care planning intervention. For the study to be able to meet this request, all families randomized to the intervention will first complete the Carer Support Needs Assessment Tool (CSNAT)© which our investigative team adapted for use in pediatrics. In the CSNAT Approach, facilitators assess caregivers' prioritized palliative care needs and develop Shared Action Plans for palliative care support. Thus, we propose an innovative 3-session FACE-Rare intervention, integrating two evidence-based approaches. We will evaluate FACE-Rare using a scientifically rigorous intent-to-treat, single-blinded, randomized controlled trial design. Family/child pairs or dyads (N=30 dyads) will be randomized to FACE-Rare (CSNAT Sessions 1 & 2 plus Respecting Choices Sessions 3) or control (Treatment As Usual) groups. Both groups will receive palliative care information. All families will complete questionnaires at baseline and 3-months follow-up. Investigators will evaluate the initial efficacy of FACE-Rare on family quality of life (psychological, spiritual). We will estimate how religiousness and caregiver appraisal influence families' quality of life. We will also explore health care utilization by the children during the study and family satisfaction. If the aims of this pilot trial are achieved, a future, large, multi-site trial will test the full theoretical model to improve care for children with rare diseases and their families through family engaged pediatric Advance Care Planning. The ultimate goal is to minimize suffering and enhance the quality of life of family caregivers of children with rare diseases; and through this process to improve the palliative care of their children.

Interventions

BEHAVIORALFAmily CEntered (FACE) pACP Intervention

The (approximately) weekly 3-session FACE-Rare intervention of approximately 45-60 minutes each is comprised of the CSNAT approach \[Sessions 1 & 2\] and Respecting Choices \[Session 3\].

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Masking description

Study arm allocation will be concealed from the Research Assistant (RA) Assessor to prevent bias during the administration of outcome questionnaires, process measures, and chart abstraction.

Intervention model description

Investigators propose a pilot, two-arm, intent-to-treat, single-blinded, single-site, controlled RCT. Family/child dyads (N=30) will be enrolled and randomized to either the FACE-Rare intervention or treatment as usual (TAU) at a 1:1 ratio.

Eligibility

Sex/Gender

ALL

Age

1 Years to 99 Years

Healthy volunteers

Inclusion criteria

Child inclusion criteria are 1. ≥1.0 years and \<18.0 years at enrollment;e 2. unable to participate in end-of-life care decision-making; 3. have a rare disease as operationally defined (See Human Subjects); 4. not under a Do Not Resuscitate Order or Allow a Natural Death Order; and 5. not in the Intensive Care Unit. Family caregiver inclusion criteria are: 1. ≥ 18.0 years at enrollment; 2. legal guardian of child and child's caregiver; 3. can speak and understand English; and 4. not known to be developmentally delayed.

Exclusion criteria

(1) Family caregiver is actively homicidal, suicidal, or psychotic at the time of enrollment.

Design outcomes

Primary

Measure	Time frame	Description
Advance Care Plan Document for Children With Rare Diseases	Change from Baseline ACP Documentation in the Electronic Health Record at 12 weeks Post-Enrollment	Advanced Care Planning (ACP) Documentation in Electronic Health Records (EHR). Score will be present in EHR or absent from EHR. Evidence of any advance care document (yes/no) will count.
Days in Palliative Care Prior to Death	12 weeks Post-Enrollment	Score is number of days patient was enrolled in a palliative care program in the 30 days prior to death. Applicable only to patients who have deceased since study enrollment. Used to standardize child healthcare utilization from data abstraction based on retrospective medical chart review. Minimum value is 0 with no maximum. Higher score indicates higher level of healthcare utilization.
Hospitalizations	Change from Baseline to Frequency at 12 weeks Post-Enrollment	Used to standardize child healthcare utilization from data abstraction by the research nurse based on medical chart review in Electronic Health Record. Score is recorded number of inpatient hospital admissions for clinical treatment for the child with a rare disease. Minimum value is 0 with no maximum. Higher score indicates higher level of healthcare utilization. Questions was Hospitalization in the last 3 months?
Place of Death	12 weeks Post-Enrollment	Location where the patient was pronounced dead, as reported in their EMR. Applicable only to patients who have deceased since study enrollment. Categories are Inpatient hospice setting, Home with hospice, Home without hospice, Hospital ICU, Hospital-Not ICU, Other, or Unknown. Used to standardize child healthcare utilization from data abstraction based on retrospective medical chart review.
Beck Anxiety Inventory	Change from Baseline Anxiety at 3 Months Post-Enrollment	The Beck Anxiety Inventory (BAI) is a 21-item measure of anxiety rated on a 4-point Likert scale of symptoms over the past week. The BAI has demonstrated reliability and validity to assess anxiety in individuals aged 17-80 years. The BAI has good reliability and validity for family caregivers of seriously ill children. It is a measure of Quality of life: emotional health. Higher scores mean more anxiety symptoms. Total score was used in analysis. Scores range from 0-63.
Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4	Change from Baseline Spiritual Well-Being at 3 Months Post-Enrollment	Assessed construct of spiritual well-being. Two subscales Meaning/Peace (7 items) and Faith (5 items) and Total score (12 items) were calculated. on a 5-point Likert scale from 0=not at all to 5=very much. Some items are reverse scored. See www.facit.org Meaning/Peace subscale score range from minimum value of 0 to maximum value of 32. Higher scores indicate better meaning/peace. Faith subscale score range from 0 minimum value to maximum value of 16. Higher scores indicate better meaning/peace. Higher scores indicate better spiritual well-being.

Secondary

Measure	Time frame	Description
Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline and 3-month follow-up.	Survey responses to: 1. How often do you feel God's presence? On 6-point Likert-scale responses range from every day to never or almost never.
Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Change from Baseline appraisal of Caregiving at 12 weeks Post-Enrollment	The FACQ-PC is a 25-item measure consists of four theoretically derived subscales: (i) caregiver strain, (ii) positive caregiving appraisals, (iii) caregiver distress, and (iv) family well-being. Scores are from 5 = strongly agree to 1 = strongly disagree. We did not calculate a Total score. We only used the 4 subscale scores. On the subscale scores for positive caregiving appraisals and family well-being, higher scores mean better outcomes, i.e. greater positive caregiving appraisals or family well-being. On the subscale scores for caregiver strain and caregiver distress, higher scores mean worse outcomes, i.e. greater caregiver strain or caregiver distress. The FACQ-PC subscale scores were computed by taking the mean of the items (score range 1-5). Some items were reverse scored, depending on how the item is phrased, so that higher scores = higher amount of the subscale being measured. So the minimum value for each subscale is 1 and the maximum value for each subscale is 5.
Hickman Role Stress Decisional Burden Scale	Up to 5 Weeks Post-Enrollment	Visual analogue scale 0-100. How stressful is it for you to make medical decisions for your child? 1 item. Higher score means more stress, lower scores mean less stress.
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline and 3-month follow-up	Responses to survey question 2, How often do you pray privately? 7 point Likert scale ranging from a few times a month to once a day. Higher scores in pray item indicate more prayer.

Other

Measure	Time frame	Description
Satisfaction Questionnaire (Process Measure)	Up to 5 Weeks Post-Baseline	Items for this 13-item assessment of family satisfaction with the intervention were developed using input from the community about the emotional aspects of participation. Items are on a 5-point Likert scale from strongly disagree to strongly agree. 6 items were negative (felt afraid, too much to handle, harmful, angry, sad hurtful) and 7 items were positive (useful, helpful, load off my mind, satisfied, something I needed to do, courageous, worthwhile). Each item was scored separately. Higher score for positive scale was better outcome. Higher score for negative scale was worse outcome. Study-specific process measure to assess adverse events and benefit/burden of participation. 12 items Total.
Quality of Communication Questionnaire	Up to 5 Weeks Post-Baseline	This is a process, not an outcome, measure. The participant is asked to rate how good the facilitator was for each of 4 communication skills on a scale from 0, definitely no, to 5, definitely yes. Higher scores mean better communication. Minimum score was 4. Maximum score was 20. We did not calculate a total score, as this was a process measure to assess the facilitator's communication and to provide feedback to the facilitator.
Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	Baseline to 3 month follow-up	Responses to How often do you go to religious services? Responses ranged from once or twice a year to more than once a week. Higher scores indicated greater attendance at religious services. Responses were used as a covariate in the initial Generalized linear mixed effect models. Prior research had indicated that this variable moderated quality of life outcomes. Higher scores indicate more attendance at religious services.
Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	Baseline and 3 month follow-up	Responses to To what extent do you consider yourself a religious person? Responses ranged from moderately religious to not religious at all. Higher scores indicated higher religiousness. Responses were collected as a covariate in the initial Generalized linear mixed effect models. Prior research had indicated that this variable moderated quality of life outcomes. Higher scores in the religious indicate self-perception as a more religious person.
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	Baseline to 3 month outcomes.	Responses to To What Extent do You Consider Yourself a spiritual person? Responses ranged from not spiritual at all to very spiritual. Higher score meant more spiritual. Reported are frequency distributions and percentages. A higher score on the spiritual person item indicates self-perception as more spiritual.

Countries

United States

Participant flow

Recruitment details

Family caregivers were recruited from outpatient clinics at Children's National Hospital, a quaternary pediatric hospital. There were 21 children and 21 primary family caregivers enrolled in the study. Randomization was at the level of the dyad (child with a rare disease and the primary family caregiver). Thus, 42 participants (21 child/family dyads) completed the baseline assessment and were then randomized. The flow chart is reported as adolescent/family dyads.

Participants by arm

Arm	Count
FACE-Rare Intervention FACE-Rare is a behavioral intervention that combines the CSNAT Pediatric Approach and the Respecting Choices® Next Steps ACP over 3 sessions. Sessions 1&2: CSNAT is an evidence-based process of family caregiver assessment and support in specialized medical (palliative) care. The CSNAT tool is structured around 16 categories of family caregiver support. With the goal to decrease caregiver burden, this process consists of 5 stages wherein a nurse or practitioner works with the caregiver to create a shared support plan for the child. Session 3: Respecting Choices® Next Steps- This advanced care planning (pACP) conversation engages families in a process for how to make future medical decisions consistent with their goals and values. The interview is structured in 6 stages to achieve 2 main goals: to facilitate conversations with the family about their child's medical condition, history, fears, values, beliefs, and hopes; and to set the stage for the family's future healthcare decisions. FAmily CEntered (FACE) pACP Intervention: The (approximately) weekly 3-session FACE-Rare intervention of approximately 45-60 minutes each is comprised of the CSNAT approach \[Sessions 1 & 2\] and Respecting Choices \[Session 3\].	18
Treatment-as-Usual (TAU) Control To minimize the burden to families, we have chosen a Treatment-as-Usual (TAU) comparison condition, where patients will receive their normal standard of care. Both study arms will receive palliative (specialized medical) care information at enrollment and complete questionnaires before and after the intervention or TAU period. Current practice for minors with life-limiting illnesses is to defer initial discussions of advanced care planning (pACP) until a medical crisis, so this is what the TAU control arm condition will consist of.	24
Total	42

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	2

Baseline characteristics

Characteristic	FACE-Rare Intervention	Treatment-as-Usual (TAU) Control	Total
Age, Categorical Child with rare disease <=18 years	9 Participants	12 Participants	21 Participants
Age, Categorical Child with rare disease >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Child with rare disease Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Primary family caregiver <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical Primary family caregiver >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Primary family caregiver Between 18 and 65 years	9 Participants	12 Participants	21 Participants
Race (NIH/OMB) Child with rare disease American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Child with rare disease Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Child with rare disease Black or African American	4 Participants	1 Participants	5 Participants
Race (NIH/OMB) Child with rare disease More than one race	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) Child with rare disease Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Child with rare disease Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Child with rare disease White	3 Participants	10 Participants	13 Participants
Race (NIH/OMB) Primary family caregiver American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Primary family caregiver Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Primary family caregiver Black or African American	3 Participants	1 Participants	4 Participants
Race (NIH/OMB) Primary family caregiver More than one race	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Primary family caregiver Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Primary family caregiver Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Primary family caregiver White	5 Participants	10 Participants	15 Participants
Region of Enrollment United States	18 participants	24 participants	42 participants
Sex: Female, Male Child with rare disease Female	5 Participants	6 Participants	11 Participants
Sex: Female, Male Child with rare disease Male	4 Participants	6 Participants	10 Participants
Sex: Female, Male Primary family caregiver Female	7 Participants	10 Participants	17 Participants
Sex: Female, Male Primary family caregiver Male	2 Participants	2 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 9	0 / 12	0 / 9	0 / 12
other Total, other adverse events	0 / 9	0 / 12	0 / 9	0 / 12
serious Total, serious adverse events	0 / 9	0 / 12	0 / 9	0 / 12

Outcome results

Primary

Advance Care Plan Document for Children With Rare Diseases

Advanced Care Planning (ACP) Documentation in Electronic Health Records (EHR). Score will be present in EHR or absent from EHR. Evidence of any advance care document (yes/no) will count.

Time frame: Change from Baseline ACP Documentation in the Electronic Health Record at 12 weeks Post-Enrollment

Population: Advance care plan for child documented in the Electronic Health Record.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
FACE-Rare Intervention	Advance Care Plan Document for Children With Rare Diseases	Baseline	No	8 Participants
FACE-Rare Intervention	Advance Care Plan Document for Children With Rare Diseases	Baseline	Yes	1 Participants
FACE-Rare Intervention	Advance Care Plan Document for Children With Rare Diseases	3-month follow-up	No	6 Participants
FACE-Rare Intervention	Advance Care Plan Document for Children With Rare Diseases	3-month follow-up	Yes	3 Participants
Treatment-as-Usual (TAU) Control	Advance Care Plan Document for Children With Rare Diseases	3-month follow-up	Yes	0 Participants
Treatment-as-Usual (TAU) Control	Advance Care Plan Document for Children With Rare Diseases	Baseline	No	12 Participants
Treatment-as-Usual (TAU) Control	Advance Care Plan Document for Children With Rare Diseases	3-month follow-up	No	12 Participants
Treatment-as-Usual (TAU) Control	Advance Care Plan Document for Children With Rare Diseases	Baseline	Yes	0 Participants

Primary

Beck Anxiety Inventory

The Beck Anxiety Inventory (BAI) is a 21-item measure of anxiety rated on a 4-point Likert scale of symptoms over the past week. The BAI has demonstrated reliability and validity to assess anxiety in individuals aged 17-80 years. The BAI has good reliability and validity for family caregivers of seriously ill children. It is a measure of Quality of life: emotional health. Higher scores mean more anxiety symptoms. Total score was used in analysis. Scores range from 0-63.

Time frame: Change from Baseline Anxiety at 3 Months Post-Enrollment

Population: Data analysis was with the family caregivers.

Arm	Measure	Group	Value (MEAN)	Dispersion
FACE-Rare Intervention	Beck Anxiety Inventory	Baseline Total score	10.4 score on a scale	Standard Deviation 8.5
FACE-Rare Intervention	Beck Anxiety Inventory	3 month follow-up Total Score	11.1 score on a scale	Standard Deviation 8
Treatment-as-Usual (TAU) Control	Beck Anxiety Inventory	Baseline Total score	9.5 score on a scale	Standard Deviation 9.5
Treatment-as-Usual (TAU) Control	Beck Anxiety Inventory	3 month follow-up Total Score	8.5 score on a scale	Standard Deviation 9.6

p-value: 0.83595% CI: [0.661, 1.396]Mixed Models Analysis

Primary

Days in Palliative Care Prior to Death

Score is number of days patient was enrolled in a palliative care program in the 30 days prior to death. Applicable only to patients who have deceased since study enrollment. Used to standardize child healthcare utilization from data abstraction based on retrospective medical chart review. Minimum value is 0 with no maximum. Higher score indicates higher level of healthcare utilization.

Time frame: 12 weeks Post-Enrollment

Population: Child with rare disease. No child with a rare disease died during the study, so data for Days in Palliative Care Prior to death was not collected.

Primary

Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4

Assessed construct of spiritual well-being. Two subscales Meaning/Peace (7 items) and Faith (5 items) and Total score (12 items) were calculated. on a 5-point Likert scale from 0=not at all to 5=very much. Some items are reverse scored. See www.facit.org Meaning/Peace subscale score range from minimum value of 0 to maximum value of 32. Higher scores indicate better meaning/peace. Faith subscale score range from 0 minimum value to maximum value of 16. Higher scores indicate better meaning/peace. Higher scores indicate better spiritual well-being.

Time frame: Change from Baseline Spiritual Well-Being at 3 Months Post-Enrollment

Population: Family caregivers of children with rare diseases.

Arm	Measure	Group	Value (MEDIAN)
FACE-Rare Intervention	Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4	Baseline Meaning/Peace	24.0 score on a scale
FACE-Rare Intervention	Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4	3 month Meaning/Peace	26.0 score on a scale
FACE-Rare Intervention	Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4	Baseline Faith	11.0 score on a scale
FACE-Rare Intervention	Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4	3 month Faith	9.0 score on a scale
Treatment-as-Usual (TAU) Control	Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4	3 month Faith	7.0 score on a scale
Treatment-as-Usual (TAU) Control	Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4	Baseline Meaning/Peace	25.0 score on a scale
Treatment-as-Usual (TAU) Control	Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4	Baseline Faith	6.0 score on a scale
Treatment-as-Usual (TAU) Control	Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4	3 month Meaning/Peace	26.0 score on a scale

Comparison: Meaning/Peace subscale which was a primary outcome.p-value: 0.03295% CI: [0.75, 0.986]Mixed Models Analysis

Primary

Hospitalizations

Used to standardize child healthcare utilization from data abstraction by the research nurse based on medical chart review in Electronic Health Record. Score is recorded number of inpatient hospital admissions for clinical treatment for the child with a rare disease. Minimum value is 0 with no maximum. Higher score indicates higher level of healthcare utilization. Questions was Hospitalization in the last 3 months?

Time frame: Change from Baseline to Frequency at 12 weeks Post-Enrollment

Population: Children with rare diseases.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
FACE-Rare Intervention	Hospitalizations	Baseline	Yes	2 Participants
FACE-Rare Intervention	Hospitalizations	3-month follow-up	Yes	2 Participants
FACE-Rare Intervention	Hospitalizations	3-month follow-up	No	7 Participants
FACE-Rare Intervention	Hospitalizations	Baseline	No	7 Participants
Treatment-as-Usual (TAU) Control	Hospitalizations	3-month follow-up	No	8 Participants
Treatment-as-Usual (TAU) Control	Hospitalizations	Baseline	Yes	5 Participants
Treatment-as-Usual (TAU) Control	Hospitalizations	Baseline	No	7 Participants
Treatment-as-Usual (TAU) Control	Hospitalizations	3-month follow-up	Yes	4 Participants

Primary

Place of Death

Location where the patient was pronounced dead, as reported in their EMR. Applicable only to patients who have deceased since study enrollment. Categories are Inpatient hospice setting, Home with hospice, Home without hospice, Hospital ICU, Hospital-Not ICU, Other, or Unknown. Used to standardize child healthcare utilization from data abstraction based on retrospective medical chart review.

Time frame: 12 weeks Post-Enrollment

Population: Child with a rare disease. No child with a rare disease died during the study, so Place of Death was not collected.

Secondary

Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.

Responses to survey question 2, How often do you pray privately? 7 point Likert scale ranging from a few times a month to once a day. Higher scores in pray item indicate more prayer.

Time frame: Baseline and 3-month follow-up

Population: Family caregivers of children with rare diseases.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	A few times a month	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	A few times a week	1 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	More than once a day	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	Never	1 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	Once a month	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	Less than once a month	0 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	Once a day	0 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	A few times a month	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	A few times a week	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	More than once a day	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	Never	1 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	Once a month	1 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	Less than once a month	0 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	Once a day	0 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	Never	1 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	A few times a month	2 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	A few times a month	2 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	A few times a week	3 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	Less than once a month	1 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	More than once a day	3 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	A few times a week	4 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	Never	2 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	Once a month	0 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	Once a month	0 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	More than once a day	3 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	Less than once a month	1 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	3 month follow-up How often do you pray privately?	Once a day	1 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.	Baseline How often do you pray privately?	Once a day	1 Participants

Secondary

Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1

Survey responses to: 1. How often do you feel God's presence? On 6-point Likert-scale responses range from every day to never or almost never.

Time frame: Baseline and 3-month follow-up.

Population: Primary family caregivers of children with rare diseases.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Declined	1 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Every day	3 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Most days	1 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Once in a while	3 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Some days	1 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Many times a day.	0 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Never or almost never	0 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Declined	0 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Every day	2 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Most days	2 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Once in a while	1 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Some days	1 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Many times a day.	1 Participants
FACE-Rare Intervention	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Never or almost never	2 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Once in a while	5 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Declined	0 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Declined	0 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Every day	1 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Many times a day.	1 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Most days	3 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Every day	4 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Once in a while	5 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Some days	0 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Some days	2 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Most days	2 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Many times a day.	0 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	3-month follow up -How often do you feel God's presence?	Never or almost never	0 Participants
Treatment-as-Usual (TAU) Control	Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1	Baseline How often do you feel God's presence?	Never or almost never	1 Participants

Secondary

Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)

The FACQ-PC is a 25-item measure consists of four theoretically derived subscales: (i) caregiver strain, (ii) positive caregiving appraisals, (iii) caregiver distress, and (iv) family well-being. Scores are from 5 = strongly agree to 1 = strongly disagree. We did not calculate a Total score. We only used the 4 subscale scores. On the subscale scores for positive caregiving appraisals and family well-being, higher scores mean better outcomes, i.e. greater positive caregiving appraisals or family well-being. On the subscale scores for caregiver strain and caregiver distress, higher scores mean worse outcomes, i.e. greater caregiver strain or caregiver distress. The FACQ-PC subscale scores were computed by taking the mean of the items (score range 1-5). Some items were reverse scored, depending on how the item is phrased, so that higher scores = higher amount of the subscale being measured. So the minimum value for each subscale is 1 and the maximum value for each subscale is 5.

Time frame: Change from Baseline appraisal of Caregiving at 12 weeks Post-Enrollment

Population: Primary family caregivers of children with a rare disease.

Arm	Measure	Group	Value (MEDIAN)
FACE-Rare Intervention	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Caregiver strain subscale baseline	3.3 score on a scale
FACE-Rare Intervention	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Positive caregiving appraisals Baseline	4.7 score on a scale
FACE-Rare Intervention	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Caregiver Distress Baseline	3.3 score on a scale
FACE-Rare Intervention	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Family well-being baseline	4.2 score on a scale
FACE-Rare Intervention	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	caregiver strain 3 Month follow up	3.5 score on a scale
FACE-Rare Intervention	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Positive caregiving appraisals 3 month follow up	4.7 score on a scale
FACE-Rare Intervention	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Caregiver distress 3 month follow up	2.8 score on a scale
FACE-Rare Intervention	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Family well-being 3 month follow up	4.5 score on a scale
Treatment-as-Usual (TAU) Control	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Family well-being 3 month follow up	4.2 score on a scale
Treatment-as-Usual (TAU) Control	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Caregiver strain subscale baseline	3.0 score on a scale
Treatment-as-Usual (TAU) Control	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	caregiver strain 3 Month follow up	2.9 score on a scale
Treatment-as-Usual (TAU) Control	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Positive caregiving appraisals Baseline	4.6 score on a scale
Treatment-as-Usual (TAU) Control	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Caregiver distress 3 month follow up	3.4 score on a scale
Treatment-as-Usual (TAU) Control	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Caregiver Distress Baseline	3.5 score on a scale
Treatment-as-Usual (TAU) Control	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Positive caregiving appraisals 3 month follow up	4.6 score on a scale
Treatment-as-Usual (TAU) Control	Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)	Family well-being baseline	4.2 score on a scale

Comparison: Caregiver strain subscale scores at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.p-value: 0.28495% CI: [0.959, 1.157]Mixed Models Analysis

Comparison: Caregiver distress subscale controlling for baseline levels.p-value: 0.22895% CI: [0.827, 1.048]Mixed Models Analysis

Comparison: Family well-being subscale controlling for baseline levels.p-value: 0.50495% CI: [0.94, 1.032]Mixed Models Analysis

Comparison: Positive Caregiving Appraisals subscale at 3 month follow up, controlling for baseline levels.p-value: 0.74195% CI: [0.967, 1.024]Mixed Models Analysis

Secondary

Hickman Role Stress Decisional Burden Scale

Visual analogue scale 0-100. How stressful is it for you to make medical decisions for your child? 1 item. Higher score means more stress, lower scores mean less stress.

Time frame: Up to 5 Weeks Post-Enrollment

Population: Primary caregiver of child with rare disease.

Arm	Measure	Group	Value (MEDIAN)
FACE-Rare Intervention	Hickman Role Stress Decisional Burden Scale	Baseline	75 raw score units on a scale
FACE-Rare Intervention	Hickman Role Stress Decisional Burden Scale	3-month follow-up	75.0 raw score units on a scale
Treatment-as-Usual (TAU) Control	Hickman Role Stress Decisional Burden Scale	Baseline	71.0 raw score units on a scale
Treatment-as-Usual (TAU) Control	Hickman Role Stress Decisional Burden Scale	3-month follow-up	72.5 raw score units on a scale

Other Pre-specified

Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?

Responses to To What Extent do You Consider Yourself a spiritual person? Responses ranged from not spiritual at all to very spiritual. Higher score meant more spiritual. Reported are frequency distributions and percentages. A higher score on the spiritual person item indicates self-perception as more spiritual.

Time frame: Baseline to 3 month outcomes.

Population: Family caregivers of children with rare diseases.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? Baseline	Moderately spiritual	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? Baseline	Not spiritual at all	1 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? Baseline	Slightly spiritual	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? Baseline	Very spiritual	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? 3 month follow up	Moderately spiritual	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? 3 month follow up	Not spiritual at all	1 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? 3 month follow up	Slightly spiritual	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? 3 month follow up	Very spiritual	3 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? 3 month follow up	Very spiritual	4 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? Baseline	Moderately spiritual	7 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? 3 month follow up	Moderately spiritual	4 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? Baseline	Not spiritual at all	0 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? 3 month follow up	Slightly spiritual	4 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? Baseline	Slightly spiritual	5 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? 3 month follow up	Not spiritual at all	0 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?	To what extent do you consider yourself a spiritual person? Baseline	Very spiritual	0 Participants

Other Pre-specified

Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?

Responses to How often do you go to religious services? Responses ranged from once or twice a year to more than once a week. Higher scores indicated greater attendance at religious services. Responses were used as a covariate in the initial Generalized linear mixed effect models. Prior research had indicated that this variable moderated quality of life outcomes. Higher scores indicate more attendance at religious services.

Time frame: Baseline to 3 month follow-up

Population: Family caregivers of children with rare diseases.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Every month or so	1 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Never	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Once or twice a month	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Once or twice a year	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Every week or more often	0 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	More than once a week	0 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Every month or so	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Never	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Once or twice a month	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Once or twice a year	1 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Every week or more often	0 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	More than once a week	0 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Every week or more often	3 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Every month or so	2 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Every month or so	1 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Never	3 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Once or twice a year	3 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Once or twice a month	1 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Never	4 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Once or twice a year	3 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	More than once a week	0 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	Every week or more often	2 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? 3 month follow up	Once or twice a month	1 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?	How often do you go to religious services? baseline	More than once a week	1 Participants

Other Pre-specified

Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?

Responses to To what extent do you consider yourself a religious person? Responses ranged from moderately religious to not religious at all. Higher scores indicated higher religiousness. Responses were collected as a covariate in the initial Generalized linear mixed effect models. Prior research had indicated that this variable moderated quality of life outcomes. Higher scores in the religious indicate self-perception as a more religious person.

Time frame: Baseline and 3 month follow-up

Population: Family caregivers of children with rare diseases.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? Baseline	Moderately religious	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? Baseline	Not religious at all	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? Baseline	Slightly religious	1 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? Baseline	Very religious	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? 3 month follow up	Moderately religious	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? 3 month follow up	Not religious at all	2 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? 3 month follow up	Slightly religious	3 Participants
FACE-Rare Intervention	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? 3 month follow up	Very religious	2 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? 3 month follow up	Very religious	1 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? Baseline	Moderately religious	4 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? 3 month follow up	Moderately religious	2 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? Baseline	Not religious at all	2 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? 3 month follow up	Slightly religious	6 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? Baseline	Slightly religious	4 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? 3 month follow up	Not religious at all	3 Participants
Treatment-as-Usual (TAU) Control	Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?	To what extent do you consider yourself a religious person? Baseline	Very religious	2 Participants

Other Pre-specified

Quality of Communication Questionnaire

This is a process, not an outcome, measure. The participant is asked to rate how good the facilitator was for each of 4 communication skills on a scale from 0, definitely no, to 5, definitely yes. Higher scores mean better communication. Minimum score was 4. Maximum score was 20. We did not calculate a total score, as this was a process measure to assess the facilitator's communication and to provide feedback to the facilitator.

Time frame: Up to 5 Weeks Post-Baseline

Population: Family caregivers of children living with rare diseases.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
FACE-Rare Intervention	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Definitely yes	8 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Do Not Know	1 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Probably yes	4 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Declined	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Definitely no	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Missing	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Definitely yes	4 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Do Not Know	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Probably yes	1 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Declined	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Definitely no	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Missing	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Definitely yes	9 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Do Not Know	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Probably yes	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Declined	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Definitely no	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Missing	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Definitely yes	9 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Do Not Know	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Probably yes	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Declined	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Definitely no	0 Participants
FACE-Rare Intervention	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Missing	0 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Definitely no	0 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Definitely yes	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Definitely yes	8 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Do Not Know	5 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Definitely yes	10 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Probably yes	3 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Do Not Know	0 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Declined	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Declined	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Definitely no	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Probably yes	2 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	1. Do you think that your attitudes are known by the interviewer?	Missing	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Do Not Know	0 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Definitely yes	6 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Declined	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Do Not Know	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Missing	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Probably yes	3 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Definitely no	0 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Declined	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	4. Did you feel that the interviewer gave you enough attention?	Probably yes	0 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Definitely no	0 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	3. Did you feel that the interviewer listened to what you said?	Missing	1 Participants
Treatment-as-Usual (TAU) Control	Quality of Communication Questionnaire	2. Did you feel that the interviewer cared about you as a person?	Missing	1 Participants

Other Pre-specified

Satisfaction Questionnaire (Process Measure)

Items for this 13-item assessment of family satisfaction with the intervention were developed using input from the community about the emotional aspects of participation. Items are on a 5-point Likert scale from strongly disagree to strongly agree. 6 items were negative (felt afraid, too much to handle, harmful, angry, sad hurtful) and 7 items were positive (useful, helpful, load off my mind, satisfied, something I needed to do, courageous, worthwhile). Each item was scored separately. Higher score for positive scale was better outcome. Higher score for negative scale was worse outcome. Study-specific process measure to assess adverse events and benefit/burden of participation. 12 items Total.

Time frame: Up to 5 Weeks Post-Baseline

Population: Family caregivers of children with rare diseases

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Agree	5 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	1. It was useful	Strongly disagree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	1. It was useful	Disagree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	1. It was useful	Neither agree or disagree.	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	1. It was useful	Agree	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	1. It was useful	Strongly agree.	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Strongly disagree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Disagree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Neither agree or disagree.	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Agree	4 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Strongly agree.	2 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Strongly disagree	4 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Disagree	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Neither agree or disagree.	2 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Agree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Strongly agree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Strongly disagree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Disagree	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Neither agree or disagree.	2 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Agree	4 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Strongly agree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Strongly disagree	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Disagree	4 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Neither agree or disagree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Agree	2 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Strongly agree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Strongly disagree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Disagree	1 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Neither agree or disagree.	2 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Agree	6 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Strongly agree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Strongly disagree	6 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Disagree	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Neither agree or disagree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Agree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Strongly agree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Strongly disagree	6 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Disagree	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Neither agree or disagree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Agree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Strongly agree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Strongly disagree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Disagree	1 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Neither agree or disagree.	1 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Agree	4 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Strongly agree.	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Strongly disagree	1 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Disagree	2 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Neither agree or disagree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Agree	7 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Strongly agree.	1 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Strongly disagree	1 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Disagree	2 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Neither agree or disagree.	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Agree	3 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Strongly agree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Strongly disagree	5 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Disagree	4 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Neither agree or disagree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Agree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Strongly agree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Strongly disagree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Disagree	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Neither agree or disagree.	0 Participants
FACE-Rare Intervention	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Strongly agree.	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Agree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Neither agree or disagree.	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	1. It was useful	Strongly disagree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Agree	7 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	1. It was useful	Disagree	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Agree	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	1. It was useful	Neither agree or disagree.	4 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Strongly agree.	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	1. It was useful	Agree	4 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Strongly agree.	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	1. It was useful	Strongly agree.	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Neither agree or disagree.	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Strongly disagree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Strongly disagree	10 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Disagree	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Strongly disagree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Neither agree or disagree.	4 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Disagree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Agree	4 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Disagree	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	2. It was helpful	Strongly agree.	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Neither agree or disagree.	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Strongly disagree	9 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Disagree	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Disagree	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Agree	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Neither agree or disagree.	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Agree	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Agree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	8. I felt angry.	Strongly agree.	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	3. I felt scared or afraid	Strongly agree.	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Neither agree or disagree.	6 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Strongly disagree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Strongly disagree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Disagree	3 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Strongly agree.	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Neither agree or disagree.	7 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Disagree	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Agree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Agree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	4. It felt like a load off my mind.	Strongly agree.	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Neither agree or disagree.	5 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Strongly disagree	5 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Strongly agree.	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Disagree	5 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Agree	4 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Neither agree or disagree.	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	111. I felt courageous.	Strongly agree.	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Agree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	9. It was something I needed to do.	Strongly agree.	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	5. It was too much to handle.	Strongly agree.	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Neither agree or disagree.	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Strongly disagree	0 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Strongly disagree	7 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Disagree	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Strongly disagree	9 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Neither agree or disagree.	4 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Disagree	3 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Agree	4 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	13. It was worthwhile.	Strongly disagree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	6. I felt satisfied.	Strongly agree.	2 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	10. I felt sad.	Neither agree or disagree.	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Strongly disagree	10 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	12. It felt harmful.	Disagree	1 Participants
Treatment-as-Usual (TAU) Control	Satisfaction Questionnaire (Process Measure)	7. It was harmful.	Disagree	1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

FACE for Children With Rare Diseases

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Advance Care Plan Document for Children With Rare Diseases

Beck Anxiety Inventory

Days in Palliative Care Prior to Death

Functional Assessment of Chronic Illness Therapy (FACIT)- Spiritual Well-Being Scale, Version 4

Hospitalizations

Place of Death

Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Survey Responses to Question 2.

Brief-Multidimensional Measure of Religion and Spirituality - Responses to Question 1

Family Appraisal of Caregiving Questionnaire for Palliative Care for Palliative Care (FACQ-PC)

Hickman Role Stress Decisional Burden Scale

Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted): To What Extent do You Consider Yourself a Spiritual Person?

Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS) How Often do You go to Religious Services?

Brief Multidimensional Measure of Religiousness/Spirituality (Brief MMRS): To What Extent do You Consider Yourself a Religious Person?

Quality of Communication Questionnaire

Satisfaction Questionnaire (Process Measure)