Pediatric Feeding Disorder, Chronic, Pediatric Feeding Dysfunction, Acute
Conditions
Brief summary
This is a pilot study of randomized clinical trial of Parent Acceptance and Commitment Therapy (PACT) vs. an attention-control condition (placebo) for improving the mental health of parents of children with pediatric feeding disorder. The goal of this clinical trial is to compare two programs in parents of children with pediatric feeding disorders. The main question\[s\] it aims to answer are: * PACT will result in clinically meaningful reductions in Mental Health(MH) problems among parents of children with Pediatric Feed Disorder (PFD) * Identify factors that impact the feasibility of PACT delivery * Participants will asked to participate in one of two programs focused on parents of children with pediatric feeding disorders. * The participants will also be asked to complete a battery of questionnaires at four timepoints during the study. * The parents will be asked to video record a meal time twice during study. If there is a comparison group: Researchers will compare the PACT group with a control group to see if PACT will result in clinically meaningful change in parent stress and anxiety, and parent use of positive mealtime behaviors.
Detailed description
The goal of this study is to advance the science of a brief parent mental health intervention for parents of children with pediatric feeding disorder using Parent Acceptance and Commitment Therapy (PACT-F). The ultimate goal of this research is to improve parent mental health and child health and feeding outcomes through a parent-focused behavioral intervention. PACT-F is a 2-session acceptance and commitment therapy (ACT) intervention guided by Brown and Whittingham's ACT intervention for parents of children with neurodevelopmental conditions. Intervention content is based on principles of ACT, an evidence-based treatment for adult mental health problems. The intervention content is therefore broadly applicable to all parents but was specifically tailored for the needs of parents of children with neurodevelopmental conditions. In study phase 1 of this award, the investigators adapted parent ACT for parents of children with pediatric feeding disorder (PACT-F) with consultation from 2 parents of children with pediatric feeding disorder and 2 experts in parent ACT. The investigators now have a complete treatment package that has been tailored for parents of children with pediatric feeding disorder and is ready to be piloted. Thus, in this study the investigators will conduct a feasibility and proof-of-concept pilot of a 2-session parent-focused ACT intervention tailored to meet the needs of parents of children with pediatric feeding disorder (PACT-F). The goal of this pilot is to determine factors that impact the success of recruitment, retention, assessment, and treatment delivery for the PACT-F clinical trial and to test the intervention's proof of concept (i.e., does it show a clinically meaningful signal of change in parent mental health). This study will be conducted at a single site (Children's Mercy Hospital). The investigators will pilot the clinical trial procedures and monitor feasibility success, and factors that may impact feasibility success. Participants who meet inclusion criteria will be randomized to either PACT-F or an attention control (control) condition. Participants will be blind to treatment condition (single blind study). The aim of the feasibility analyses is to evaluate factors critical to success, rather than evaluating whether the intervention is feasible or not feasible. The aim of the proof-of-concept analyses is to determine if this intervention has promise and warrants a larger efficacy trial. Parents randomized to PACT-F will complete two 90-minute PACT-F sessions individually with a study interventionist, 2 weeks apart. Parents randomized to the control group will complete two 90-minute sessions individually with a study interventionist, 2-weeks apart (focused on nutrition education). The control intervention will be parallel to the ACT intervention in all ways, including interactive components and the face-to-face time with health professionals (interventionists). The control condition intervention has already been developed by Dr. Davis's research team and covers a range of nutrition and healthy lifestyle topics including the United States Department of Agriculture's (USDA) MyPlate. An attention control condition was selected to mimic the interpersonal benefits that may come from meeting individually with a caring professional. The control condition intervention content (healthy lifestyles) was specifically chosen as it most closely reflects the types of information that parents would learn from healthcare professionals about the type of nutrition that their child needs. However, this type of intervention should not impact parent mental health. Interventionists for both conditions will be individuals with at least master's degree training in mental health or a related field. The interventions will take via tele-video conferencing to allow participants to participate from home without needing transportation to and from the hospital. Both arms of the intervention will be manualized and interventionists in both arms will be trained using didactics and role playing with the Principle Investigator(PI). Intervention fidelity will be monitored by audio/video recording all sessions. The PI (Dr. Bakula) will review recordings each week and conduct separate 1-hour weekly supervision of study interventionists for each arm of the study (PACT-F & control). Strategies will be used to promote fidelity in line with recommendations from the NIH Behavior Change Consortium. A fidelity checklist will be developed in line with adaptations to the intervention and will be piloted with study interventionists. The fidelity checklist will be refined during research team meetings. The fidelity checklist will be reviewed by the PI during supervision. Hypothesis testing: The investigators will test the hypothesis that PACT-F results in clinically meaningful change using the Reliable Change Index (RCI; success defined as RCI \> 1.96). The investigators anticipate that these procedures will be feasible, with feasibility success defined as recruitment rate above 60%, and retention, assessment completion, and intervention completion rate above 80%. Mixed methods data collection will identify factors that impact 1) recruitment rate (qualitative interviews, % meeting inclusion criteria, # of contact attempts), 2) retention rates (qualitative interviews, baseline characteristics; treatment group), 3) assessment completion rate (qualitative interviews, measure type), and 4) treatment completion rate (qualitative interviews, scheduling, treatment location). The proposed study is an important first step towards developing an evidence-based treatment that can be used with parents of children with pediatric feeding disorder. This intervention has the potential to improve parent mental health, as well as child health, and therefore has the potential to have broad public health impact.
Interventions
BEHAVIORALParent Acceptance and Commitment Therapy (PACT)
PACT is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature
BEHAVIORALControl
The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate
Sponsors
National Institute of Mental Health (NIMH)
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 1\) Must be a parent aged 18+ (primary caregiver) of 2-6-year-old child with PFD * 2\) Child must be receiving outpatient PFD treatment at Children's Mercy Hospital (CMH) * 3\) The parent must have a clinically significant elevation on at least one measure of parent MH (using established clinical cutoffs). Parents will be included regardless of whether the child has a new diagnosis or established diagnoses
Exclusion criteria
* 1\) Parent has significant cognitive impairments * 2\) Parent does not speak English * Parent unable to obtain high speed internet at home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Measured 2-week post-intervention | Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depressive symptoms. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in this outcome variable compared to those who did not. |
| General Anxiety Disorder Screener (GAD-7) | Measured 2-week post-intervention | The GAD-7 is a 7-item self-report measure of anxious symptoms. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in this outcome variable compared to those who did not. |
| Impact of Event Scale - Revised (IES-R) | Measured 2-week post-intervention | The IES-R is a 22-item self-report measure of posttraumatic stress symptoms. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in this outcome variable compared to those who did not. |
| Perceived Stress Scale (PSS) | Measured 2-week post-intervention | The PSS is a 10-item self-report measure of perceived stress. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in this outcome variable compared to those who did not. |
| Behavioral Pediatrics Feeding Assessment Scale (BPFAS) | Measured 2-week post-intervention | Behavioral Pediatrics Feeding Assessment Scale (Total Frequency Score). The scale has a possible range of 35 to 175, with higher scores indicating worse feeding problems. The BPFAS is a 35-item parent-proxy report of child mealtime and feeding behavior. This was not evaluated using the RCI and instead was only a metric evaluated for pre-post scores in the intervention group as it was an exploratory assessment. |
| Retention Rate | 3-month follow up | This is a measure of the % of participants who were able to be retained from baseline through to the end of the study (3 month follow up). This was assessed as a component of feasibility. |
| Intervention Completion Rate | Intervention Completion (2 week follow up) | This is a measure of the % of participants who started the intervention, and then successfully completed all sessions. This was assessed as a component of feasibility. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parent Acceptance and Commitment Therapy (PACT) PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature. | 14 |
| Control The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate. | 6 |
| Total | 20 |
Baseline characteristics
| Characteristic | Parent Acceptance and Commitment Therapy (PACT) | Total | Control |
|---|---|---|---|
| Age, Continuous | 35.5 years STANDARD_DEVIATION 8.39 | 34 years STANDARD_DEVIATION 7.96 | 31 years STANDARD_DEVIATION 6.66 |
| BPFAS | 91 Rating Scale STANDARD_DEVIATION 11.49 | 92.5 Rating Scale STANDARD_DEVIATION 12.22 | 96.14 Rating Scale STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 19 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| GAD7 | 8.64 Rating Scale STANDARD_DEVIATION 4.85 | 8.70 Rating Scale STANDARD_DEVIATION 4.43 | 8.83 Rating Scale STANDARD_DEVIATION 3.66 |
| IESR | 23.93 Rating Scale STANDARD_DEVIATION 19.99 | 23.40 Rating Scale STANDARD_DEVIATION 19.07 | 22.17 Rating Scale STANDARD_DEVIATION 18.43 |
| PHQ9 | 6.57 Rating Scale STANDARD_DEVIATION 4.48 | 6.80 Rating Scale STANDARD_DEVIATION 4.15 | 7.33 Rating Scale STANDARD_DEVIATION 3.56 |
| PSS | 21.21 Rating Scale STANDARD_DEVIATION 5.24 | 20.50 Rating Scale STANDARD_DEVIATION 5.08 | 18.83 Rating Scale STANDARD_DEVIATION 4.71 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 17 Participants | 5 Participants |
| Sex/Gender, Customized Female | 13 Participants | 19 Participants | 6 Participants |
| Sex/Gender, Customized Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 10 |
| other Total, other adverse events | 0 / 20 | 0 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 10 |
Outcome results
Primary
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
Behavioral Pediatrics Feeding Assessment Scale (Total Frequency Score). The scale has a possible range of 35 to 175, with higher scores indicating worse feeding problems. The BPFAS is a 35-item parent-proxy report of child mealtime and feeding behavior. This was not evaluated using the RCI and instead was only a metric evaluated for pre-post scores in the intervention group as it was an exploratory assessment.
Time frame: Measured 2-week post-intervention
Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent Acceptance and Commitment Therapy (PACT) | Behavioral Pediatrics Feeding Assessment Scale (BPFAS) | 88.69 Rating Scale | Standard Deviation 12.53 |
Primary
General Anxiety Disorder Screener (GAD-7)
The GAD-7 is a 7-item self-report measure of anxious symptoms. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in this outcome variable compared to those who did not.
Time frame: Measured 2-week post-intervention
Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parent Acceptance and Commitment Therapy (PACT) | General Anxiety Disorder Screener (GAD-7) | Significant Reliable Change Index Score | 4 Participants |
| Parent Acceptance and Commitment Therapy (PACT) | General Anxiety Disorder Screener (GAD-7) | Non-Significant Reliable Change Index Score | 10 Participants |
| Control | General Anxiety Disorder Screener (GAD-7) | Significant Reliable Change Index Score | 0 Participants |
| Control | General Anxiety Disorder Screener (GAD-7) | Non-Significant Reliable Change Index Score | 0 Participants |
Primary
Impact of Event Scale - Revised (IES-R)
The IES-R is a 22-item self-report measure of posttraumatic stress symptoms. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in this outcome variable compared to those who did not.
Time frame: Measured 2-week post-intervention
Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parent Acceptance and Commitment Therapy (PACT) | Impact of Event Scale - Revised (IES-R) | Significant Reliable Change Index Score | 2 Participants |
| Parent Acceptance and Commitment Therapy (PACT) | Impact of Event Scale - Revised (IES-R) | Non-Significant Reliable Change Index Score | 12 Participants |
| Control | Impact of Event Scale - Revised (IES-R) | Significant Reliable Change Index Score | 0 Participants |
| Control | Impact of Event Scale - Revised (IES-R) | Non-Significant Reliable Change Index Score | 0 Participants |
Primary
Intervention Completion Rate
This is a measure of the % of participants who started the intervention, and then successfully completed all sessions. This was assessed as a component of feasibility.
Time frame: Intervention Completion (2 week follow up)
Population: For participants who began the first session of the intervention (n=14 in the PACT arm, n=6 in the Control arm), this is the number of participants who subsequently completed both intervention sessions in full.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parent Acceptance and Commitment Therapy (PACT) | Intervention Completion Rate | 14 Participants |
| Control | Intervention Completion Rate | 6 Participants |
Primary
Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depressive symptoms. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in this outcome variable compared to those who did not.
Time frame: Measured 2-week post-intervention
Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parent Acceptance and Commitment Therapy (PACT) | Patient Health Questionnaire-9 (PHQ-9) | Significant Reliable Change Index Score | 2 Participants |
| Parent Acceptance and Commitment Therapy (PACT) | Patient Health Questionnaire-9 (PHQ-9) | Non-Significant Reliable Change Index Score | 12 Participants |
| Control | Patient Health Questionnaire-9 (PHQ-9) | Non-Significant Reliable Change Index Score | 0 Participants |
| Control | Patient Health Questionnaire-9 (PHQ-9) | Significant Reliable Change Index Score | 0 Participants |
Primary
Perceived Stress Scale (PSS)
The PSS is a 10-item self-report measure of perceived stress. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in this outcome variable compared to those who did not.
Time frame: Measured 2-week post-intervention
Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parent Acceptance and Commitment Therapy (PACT) | Perceived Stress Scale (PSS) | Significant Reliable Change Index Score | 3 Participants |
| Parent Acceptance and Commitment Therapy (PACT) | Perceived Stress Scale (PSS) | Non-Significant Reliable Change Index Score | 11 Participants |
| Control | Perceived Stress Scale (PSS) | Significant Reliable Change Index Score | 0 Participants |
| Control | Perceived Stress Scale (PSS) | Non-Significant Reliable Change Index Score | 0 Participants |
Primary
Retention Rate
This is a measure of the % of participants who were able to be retained from baseline through to the end of the study (3 month follow up). This was assessed as a component of feasibility.
Time frame: 3-month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parent Acceptance and Commitment Therapy (PACT) | Retention Rate | 14 Participants |
| Control | Retention Rate | 6 Participants |