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Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)

Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04999982
Acronym
PRE-CARE
Enrollment
54
Registered
2021-08-11
Start date
2021-11-30
Completion date
2025-04-01
Last updated
2025-09-02

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

Conditions

Attention Deficit/Hyperactivity Disorder, Inattention

Keywords

Parent, Caregiver, Community health worker

Brief summary

The goal of this proposed study is to pilot test a novel treatment model (PRE-CARE) addressing unmet social needs for families of preschool-age children with Attention Deficit/Hyperactivity Disorder (ADHD) symptoms. The investigators will conduct an adaptive, pilot randomized controlled trial (RCT) of the intervention with parents of 60 low-income children age 3-5 (36-71 months) with ADHD symptoms in order to: optimize intervention delivery; field test study logistics (e.g., recruitment, enrollment, randomization, retention); explore putative intervention mechanisms; and obtain estimates of study parameters to plan an appropriately powered RCT of the intervention. The PRE-CARE intervention is adapted from Well Child Care, Evaluation, Community, Resources, Advocacy, Referral, Education (WE CARE), a screening and referral intervention that has been shown to be feasible and effective in addressing the family psychosocial stressors of low-income families seen in pediatric medical homes. Given the negative impact that socioeconomic stressors can have on the health and development of young children with ADHD symptoms, tailored interventions such as PRE-CARE may serve as a vital early intervention strategy to promote long-term well-being.

Interventions

OTHERScreening

Parent-report screening for remediable, unmet social needs.

OTHERResource Packet

Provision of packet of resource sheets (Family Resource Booklet) detailing local community-based resources to address these needs, with needs that respond to family's requests highlighted.

Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.

OTHERCare as usual

Screening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Ann & Robert H Lurie Children's Hospital of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Legal guardian and primary caregiver of a child aged 36-71 months * Legal guardian or primary caregiver is age 16 years or older * Child receives pediatric care at Boston Medical Center or at one of the participating affiliated clinics * Able to understand informed consent procedures in English or Spanish * Participant has a child aged 36-71 months with an ADHD diagnosis, OR one elevated total or subscale score at the 80th percentile on the ADHD-Rating Scale-IV Preschool Version. 80th percentile cut-offs on the ADHD-Rating Scale-IV Preschool Version are as follows: * For male children, a total score ≥ 25 OR subscale score (inattention and/or hyperactivity) ≥ 12 * For female children, a total score ≥ 13 OR subscale score (inattention and/or hyperactivity) ≥ 6 for female children

Exclusion criteria

* There are no specific

Design outcomes

Primary

MeasureTime frameDescription
ADHD SymptomsBaseline, 3 months, 6 months, and 12 monthsADHD-Rating Scale (RS)-IV Preschool Version is a parent-report survey that measures presence and severity of ADHD symptoms for preschoolers. In our study, we used this measure to assess overall ADHD symptom burden. The 18-item validated scale asks parents about the 18 diagnostic criteria for ADHD and how often their child exhibits each symptom. The scale can be used as an overall score (total symptoms) or by subscales (9-item inattention subscale and 9-item hyperactivity subscale). Responses are reported by parents for each item along a 4-point Likert scale from 0 to 3, where 0=rarely or never and 3=very often. For our purposes, we computer the total score for a measure of total ADHD symptom severity, and did not use the subscales. Total scores range from 0 to 54, where lower is less ADHD symptoms/lower symptom severity, and higher scores represent higher symptom severity.
Total Resources Enrolled (Parent Report)Baseline, 3 months, 6 months, 12 monthsResource access was measured based on a parent report checklist of resources enrolled. The checklist was based on the Child HealthWatch Survey and modeled after data collected for the clinical trial testing the original social determinants intervention on which this intervention is based. The checklist included 18 resources that families could be enrolled in (for example - healthcare services, mental health care, special education, food benefits, housing assistance, etc), and asked parents to indicate which resources they were enrolled in. The end result is a count between 0 and 18 representing how many resources their family was enrolled in. Higher numbers indicate higher number of resources enrolled, whereas lower numbers indicate lower number of resources enrolled.

Secondary

MeasureTime frameDescription
Parental Attention-deficit/Hyperactivity Disorder (ADHD)baseline, 3 months, 6 months, 12 monthsAdult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist will be used to measure parent ADHD symptoms. The measure consists of 18 items matching Diagnostic and Statistical Manual IV criteria for adult ADHD. Items are scored on a 5-point Likert scale, (Never, Rarely, Sometimes, Often, Very Often). The questionnaire is scored based on number of symptoms, leadng to a score between 0 and 18 for the questionnaire. Items 1, 2, 3, 9, 12, 16, 18 are each counted as a symptom (1 point each) if the participant answers Sometimes, Often, or Very Often. Items 4, 5, 6, 7, 8, 10, 11, 13, 14, 15, 17 are each counted as a symptom (1 point each) if the participant answers Often or Very Often. Higher scores indicate higher symptom burden.
Global Perceived Stressbaseline, 3 months, 6 months, 12 monthsThe Perceived Stress Scale (PSS) will be used to measure perceptions of levels of stress within the past month using 10 items on a 4 point Likert scale indicating 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, and 4 = Very Often. Higher scores \[range 0 to 40\] are correlated with more perceived stress.
Child Psychiatric SymptomsBaseline, 6 months, 12 monthsThe Child Behavior Checklist 1.5-5 (CBCL 1.5/5) is a standardized tool used to assess child psychiatric symptoms for children 1.5-5 years old. The questionnaire obtains caregivers' ratings of 99 problem items along a Likert scale. Parents/caregivers rate each item 0=not true, 1=somewhat or sometimes true, 2=very true or often true of the child (based on the preceding 6 months). Higher scores are correlated with more psychiatric symptoms. Items can be grouped into syndrome scales or the total score can be used to represent overall psychiatric symptom severity. Here we use the total score to represent total psychiatric symptoms. Scores are reported as t-scores, where 50 indicates the population mean with a standard deviation of 10. Higher scores indicate more symptoms. On this scale, scores between 65 and 69 are considered borderline elevated, and scores of 70 or more are considered clinically significant.
PRE-CARE Feasibility and Acceptability Questionnaire3 monthsThe PRE-CARE Feasibility and Acceptability Questionnaire will be used to measure intervention satisfaction using 14 items on a 4 point Likert scale. Items will ask about satisfaction of information and resources provided, length of intervention, perceived helpfulness of intervention, and whether or not they would recommend the program to a parent of a similarly aged child. Higher scores are correlate with greater satisfaction.
Parenting Stressbaseline, 3 months, 6 months, 12 monthsThe Parenting Stress Inventory, Short Form (PSI-4-SF) will be used to measure specific levels of stress in relation to taking care of their child and the parent-child system. The scale includes 36 items, each of which uses a 4-point Likert scale from Strongly Disagree to Strongly Agree. The scale includes subscales and a Total score representing total stress on parents, reported here. Possible scores range from 36 to 180. Higher scores are correlated with more parental stress.
Parental Depressionbaseline, 3 months, 6 months, 12 monthsPatient Health Questionnaire (PHQ)-9 will be used to measure frequency and severity of parental symptoms of depression within the past two weeks. The measure is the major depressive disorder (MDD) module of the full PHQ, and scores each of the 9 Diagnostic and Statistical Manual criteria of MDD as 0 (not at all) to 3 (nearly every day), providing a 0-27 severity score. Higher scores are correlated with more parental depression.

Countries

United States

Participant flow

Pre-assignment details

We enrolled 54 parents but only 45 parents were ultimately randomized, hence the discrepancy between enrollment and participant flow.

Participants by arm

ArmCount
Intervention Group- PRE-CARE
Participants will receive the 1:1 PRE-CARE social needs navigation intervention with specific content and delivery strategy which was developed based on 1) quantitative analyses of the association between unmet social needs and ADHD symptoms in a large-scale nationally representative sample of children age 3-5, and 2) in-depth qualitative interviews with parents/guardians of preschoolers with inattention and/or hyperactivity symptoms to identify mechanisms by which unmet social needs exacerbate ADHD symptoms and functioning. Screening: Parent-report screening for remediable, unmet social needs. Resource Packet: Provision of packet of resource sheets (Family Resource Booklet) detailing local community-based resources to address these needs, with needs that respond to family's requests highlighted. Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
22
Control Group- Care as Usual
Families randomly assigned to the control condition will continue to receive care as usual, which includes screening for social needs annually at well-child visits as recommended by the American Academy of Pediatrics (AAP), followed by provision of information as needed by the family. Families will also be offered the opportunity to make research assessments available to their primary care physician for best continuity of care. Care as usual: Screening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family.
23
Total45

Baseline characteristics

CharacteristicIntervention Group- PRE-CAREControl Group- Care as UsualTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
22 Participants23 Participants45 Participants
Age, Continuous35.0 years32.0 years34.0 years
Race/Ethnicity, Customized
Hispanic
10 participants10 participants20 participants
Race/Ethnicity, Customized
More than one race
2 participants1 participants3 participants
Race/Ethnicity, Customized
Non-Hispanic Black
7 participants8 participants15 participants
Race/Ethnicity, Customized
Non-Hispanic White
2 participants4 participants6 participants
Race/Ethnicity, Customized
Other race
1 participants0 participants1 participants
Region of Enrollment
United States
22 Participants23 Participants45 Participants
Sex: Female, Male
Female
22 Participants22 Participants44 Participants
Sex: Female, Male
Male
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 23
other
Total, other adverse events
0 / 220 / 23
serious
Total, serious adverse events
0 / 220 / 23

Outcome results

Primary

ADHD Symptoms

ADHD-Rating Scale (RS)-IV Preschool Version is a parent-report survey that measures presence and severity of ADHD symptoms for preschoolers. In our study, we used this measure to assess overall ADHD symptom burden. The 18-item validated scale asks parents about the 18 diagnostic criteria for ADHD and how often their child exhibits each symptom. The scale can be used as an overall score (total symptoms) or by subscales (9-item inattention subscale and 9-item hyperactivity subscale). Responses are reported by parents for each item along a 4-point Likert scale from 0 to 3, where 0=rarely or never and 3=very often. For our purposes, we computer the total score for a measure of total ADHD symptom severity, and did not use the subscales. Total scores range from 0 to 54, where lower is less ADHD symptoms/lower symptom severity, and higher scores represent higher symptom severity.

Time frame: Baseline, 3 months, 6 months, and 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Group- PRE-CAREADHD SymptomsBaseline27.7 score on a scaleStandard Deviation 15.5
Intervention Group- PRE-CAREADHD Symptoms3 months27.7 score on a scaleStandard Deviation 17.9
Intervention Group- PRE-CAREADHD Symptoms6 months21.5 score on a scaleStandard Deviation 15.2
Intervention Group- PRE-CAREADHD Symptoms12 months21.0 score on a scaleStandard Deviation 16.8
Control Group- Care as UsualADHD Symptoms12 months23.8 score on a scaleStandard Deviation 16.5
Control Group- Care as UsualADHD SymptomsBaseline27.5 score on a scaleStandard Deviation 14.4
Control Group- Care as UsualADHD Symptoms6 months27.6 score on a scaleStandard Deviation 16.7
Control Group- Care as UsualADHD Symptoms3 months34.6 score on a scaleStandard Deviation 14.2
Primary

Total Resources Enrolled (Parent Report)

Resource access was measured based on a parent report checklist of resources enrolled. The checklist was based on the Child HealthWatch Survey and modeled after data collected for the clinical trial testing the original social determinants intervention on which this intervention is based. The checklist included 18 resources that families could be enrolled in (for example - healthcare services, mental health care, special education, food benefits, housing assistance, etc), and asked parents to indicate which resources they were enrolled in. The end result is a count between 0 and 18 representing how many resources their family was enrolled in. Higher numbers indicate higher number of resources enrolled, whereas lower numbers indicate lower number of resources enrolled.

Time frame: Baseline, 3 months, 6 months, 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Group- PRE-CARETotal Resources Enrolled (Parent Report)Baseline3.4 units on a scaleStandard Deviation 2.3
Intervention Group- PRE-CARETotal Resources Enrolled (Parent Report)3 months4.7 units on a scaleStandard Deviation 2.7
Intervention Group- PRE-CARETotal Resources Enrolled (Parent Report)6 months4.7 units on a scaleStandard Deviation 3.1
Intervention Group- PRE-CARETotal Resources Enrolled (Parent Report)12 months4.3 units on a scaleStandard Deviation 2.5
Control Group- Care as UsualTotal Resources Enrolled (Parent Report)12 months4.6 units on a scaleStandard Deviation 2.6
Control Group- Care as UsualTotal Resources Enrolled (Parent Report)Baseline4.1 units on a scaleStandard Deviation 2.7
Control Group- Care as UsualTotal Resources Enrolled (Parent Report)6 months4.1 units on a scaleStandard Deviation 2.4
Control Group- Care as UsualTotal Resources Enrolled (Parent Report)3 months4.1 units on a scaleStandard Deviation 2.3
Secondary

Child Psychiatric Symptoms

The Child Behavior Checklist 1.5-5 (CBCL 1.5/5) is a standardized tool used to assess child psychiatric symptoms for children 1.5-5 years old. The questionnaire obtains caregivers' ratings of 99 problem items along a Likert scale. Parents/caregivers rate each item 0=not true, 1=somewhat or sometimes true, 2=very true or often true of the child (based on the preceding 6 months). Higher scores are correlated with more psychiatric symptoms. Items can be grouped into syndrome scales or the total score can be used to represent overall psychiatric symptom severity. Here we use the total score to represent total psychiatric symptoms. Scores are reported as t-scores, where 50 indicates the population mean with a standard deviation of 10. Higher scores indicate more symptoms. On this scale, scores between 65 and 69 are considered borderline elevated, and scores of 70 or more are considered clinically significant.

Time frame: Baseline, 6 months, 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Group- PRE-CAREChild Psychiatric SymptomsBaseline62.6 T-scoreStandard Deviation 13.8
Intervention Group- PRE-CAREChild Psychiatric Symptoms6 months49.0 T-scoreStandard Deviation 16
Intervention Group- PRE-CAREChild Psychiatric Symptoms12 months48.3 T-scoreStandard Deviation 17.2
Control Group- Care as UsualChild Psychiatric SymptomsBaseline59.0 T-scoreStandard Deviation 15
Control Group- Care as UsualChild Psychiatric Symptoms6 months51.0 T-scoreStandard Deviation 19.6
Control Group- Care as UsualChild Psychiatric Symptoms12 months48.1 T-scoreStandard Deviation 18.5
Secondary

Global Perceived Stress

The Perceived Stress Scale (PSS) will be used to measure perceptions of levels of stress within the past month using 10 items on a 4 point Likert scale indicating 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, and 4 = Very Often. Higher scores \[range 0 to 40\] are correlated with more perceived stress.

Time frame: baseline, 3 months, 6 months, 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Group- PRE-CAREGlobal Perceived StressBaseline17.1 score on a scaleStandard Deviation 5
Intervention Group- PRE-CAREGlobal Perceived Stress6 months16.5 score on a scaleStandard Deviation 7
Intervention Group- PRE-CAREGlobal Perceived Stress3 Months16.1 score on a scaleStandard Deviation 5.1
Intervention Group- PRE-CAREGlobal Perceived Stress12 months16.1 score on a scaleStandard Deviation 5.6
Control Group- Care as UsualGlobal Perceived Stress3 Months20.1 score on a scaleStandard Deviation 4.2
Control Group- Care as UsualGlobal Perceived StressBaseline20.1 score on a scaleStandard Deviation 5.4
Control Group- Care as UsualGlobal Perceived Stress12 months19.5 score on a scaleStandard Deviation 4.7
Control Group- Care as UsualGlobal Perceived Stress6 months20.3 score on a scaleStandard Deviation 5.9
Secondary

Parental Attention-deficit/Hyperactivity Disorder (ADHD)

Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist will be used to measure parent ADHD symptoms. The measure consists of 18 items matching Diagnostic and Statistical Manual IV criteria for adult ADHD. Items are scored on a 5-point Likert scale, (Never, Rarely, Sometimes, Often, Very Often). The questionnaire is scored based on number of symptoms, leadng to a score between 0 and 18 for the questionnaire. Items 1, 2, 3, 9, 12, 16, 18 are each counted as a symptom (1 point each) if the participant answers Sometimes, Often, or Very Often. Items 4, 5, 6, 7, 8, 10, 11, 13, 14, 15, 17 are each counted as a symptom (1 point each) if the participant answers Often or Very Often. Higher scores indicate higher symptom burden.

Time frame: baseline, 3 months, 6 months, 12 months

ArmMeasureGroupValue (MEDIAN)
Intervention Group- PRE-CAREParental Attention-deficit/Hyperactivity Disorder (ADHD)Baseline3 score on a scale
Intervention Group- PRE-CAREParental Attention-deficit/Hyperactivity Disorder (ADHD)3 months4 score on a scale
Intervention Group- PRE-CAREParental Attention-deficit/Hyperactivity Disorder (ADHD)6 months1 score on a scale
Intervention Group- PRE-CAREParental Attention-deficit/Hyperactivity Disorder (ADHD)12 months1 score on a scale
Control Group- Care as UsualParental Attention-deficit/Hyperactivity Disorder (ADHD)12 months0 score on a scale
Control Group- Care as UsualParental Attention-deficit/Hyperactivity Disorder (ADHD)Baseline3 score on a scale
Control Group- Care as UsualParental Attention-deficit/Hyperactivity Disorder (ADHD)6 months1 score on a scale
Control Group- Care as UsualParental Attention-deficit/Hyperactivity Disorder (ADHD)3 months3 score on a scale
Secondary

Parental Depression

Patient Health Questionnaire (PHQ)-9 will be used to measure frequency and severity of parental symptoms of depression within the past two weeks. The measure is the major depressive disorder (MDD) module of the full PHQ, and scores each of the 9 Diagnostic and Statistical Manual criteria of MDD as 0 (not at all) to 3 (nearly every day), providing a 0-27 severity score. Higher scores are correlated with more parental depression.

Time frame: baseline, 3 months, 6 months, 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Group- PRE-CAREParental DepressionBaseline7.0 score on a scaleStandard Deviation 6.7
Intervention Group- PRE-CAREParental Depression3 months7.1 score on a scaleStandard Deviation 7.5
Intervention Group- PRE-CAREParental Depression6 months5.8 score on a scaleStandard Deviation 5.3
Intervention Group- PRE-CAREParental Depression12 months6.6 score on a scaleStandard Deviation 6.1
Control Group- Care as UsualParental Depression12 months6.9 score on a scaleStandard Deviation 7.7
Control Group- Care as UsualParental DepressionBaseline5.7 score on a scaleStandard Deviation 5.8
Control Group- Care as UsualParental Depression6 months6.3 score on a scaleStandard Deviation 6.7
Control Group- Care as UsualParental Depression3 months8.8 score on a scaleStandard Deviation 8.5
Secondary

Parenting Stress

The Parenting Stress Inventory, Short Form (PSI-4-SF) will be used to measure specific levels of stress in relation to taking care of their child and the parent-child system. The scale includes 36 items, each of which uses a 4-point Likert scale from Strongly Disagree to Strongly Agree. The scale includes subscales and a Total score representing total stress on parents, reported here. Possible scores range from 36 to 180. Higher scores are correlated with more parental stress.

Time frame: baseline, 3 months, 6 months, 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Group- PRE-CAREParenting StressBaseline90.3 score on a scaleStandard Deviation 24.6
Intervention Group- PRE-CAREParenting Stress3 months98.2 score on a scaleStandard Deviation 23.8
Intervention Group- PRE-CAREParenting Stress6 months89.9 score on a scaleStandard Deviation 29.8
Intervention Group- PRE-CAREParenting Stress12 months93.5 score on a scaleStandard Deviation 25.1
Control Group- Care as UsualParenting Stress12 months87.1 score on a scaleStandard Deviation 22.2
Control Group- Care as UsualParenting StressBaseline75.6 score on a scaleStandard Deviation 30.6
Control Group- Care as UsualParenting Stress6 months86.5 score on a scaleStandard Deviation 17.9
Control Group- Care as UsualParenting Stress3 months83.4 score on a scaleStandard Deviation 22.2
Secondary

PRE-CARE Feasibility and Acceptability Questionnaire

The PRE-CARE Feasibility and Acceptability Questionnaire will be used to measure intervention satisfaction using 14 items on a 4 point Likert scale. Items will ask about satisfaction of information and resources provided, length of intervention, perceived helpfulness of intervention, and whether or not they would recommend the program to a parent of a similarly aged child. Higher scores are correlate with greater satisfaction.

Time frame: 3 months

Population: Reporting percent of participants who agreed or strongly disagreed with each item

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE took too much timeAgree/Strongly Agree2 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE helped me to access resources for my familyDisagree/Strongly Disagree1 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE helped me to access resources for my familyMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE was not necessary for me and my childAgree/Strongly Agree2 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE was not necessary for me and my childDisagree/Strongly Disagree14 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE was not necessary for me and my childMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI was satisfied with the information provided in the family resource bookletAgree/Strongly Agree16 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI was satisfied with the information provided in the family resource bookletDisagree/Strongly Disagree0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI was satisfied with the information provided in the family resource bookletMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI was satisfied with the service provided in PRE-CAREAgree/Strongly Agree16 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI was satisfied with the service provided in PRE-CAREDisagree/Strongly Disagree0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI was satisfied with the service provided in PRE-CAREMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI think the family resource booklet was clear and easy to understandAgree/Strongly Agree16 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI think the family resource booklet was clear and easy to understandDisagree/Strongly Disagree0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI think the family resource booklet was clear and easy to understandMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI think there was too much information providedAgree/Strongly Agree4 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI think there was too much information providedDisagree/Strongly Disagree12 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI think there was too much information providedMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI think there was not enough information providedAgree/Strongly Agree5 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI think there was not enough information providedDisagree/Strongly Disagree11 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI think there was not enough information providedMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI was satisfied with the quality of PRE-CAREAgree/Strongly Agree16 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI was satisfied with the quality of PRE-CAREDisagree/Strongly Disagree0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI was satisfied with the quality of PRE-CAREMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI had no difficulty understanding the information provided during PRE-CAREAgree/Strongly Agree15 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI had no difficulty understanding the information provided during PRE-CAREDisagree/Strongly Disagree1 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI had no difficulty understanding the information provided during PRE-CAREMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE was too shortAgree/Strongly Agree7 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE was too shortDisagree/Strongly Disagree9 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE was too shortMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE took too much timeDisagree/Strongly Disagree13 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE took too much timeMissing1 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireThe resources I received will not improve my child's health or symptomsAgree/Strongly Agree4 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireThe resources I received will not improve my child's health or symptomsDisagree/Strongly Disagree12 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireThe resources I received will not improve my child's health or symptomsMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI would recommend PRE-CARE to another parent of a preschool-age childAgree/Strongly Agree16 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI would recommend PRE-CARE to another parent of a preschool-age childDisagree/Strongly Disagree0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnaireI would recommend PRE-CARE to another parent of a preschool-age childMissing0 Participants
Intervention Group- PRE-CAREPRE-CARE Feasibility and Acceptability QuestionnairePRE-CARE helped me to access resources for my familyAgree/Strongly Agree15 Participants

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