Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding Disorder

NCT06001398 | Completed Results

• 2 other identifiers: STUDY00002540K23MH133874
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Feeding Disorder, Chronic; Pediatric Feeding Dysfunction, Acute

Outcome Measures

Primary Outcomes (7)

• 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.

  Measured 2-week post-intervention

• 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.

  Measured 2-week post-intervention

• 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.

  Measured 2-week post-intervention

• 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.

  Measured 2-week post-intervention

• 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.

  Measured 2-week post-intervention

• 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.

  3-month follow up

• 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.

  Intervention Completion (2 week follow up)

Study Arms (2)

Parent Acceptance and Commitment Therapy (PACT)

EXPERIMENTAL

PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.

Behavioral: Parent Acceptance and Commitment Therapy (PACT)

Control

ACTIVE COMPARATOR

The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.

Behavioral: Control

Interventions

Parent Acceptance and Commitment Therapy (PACT) BEHAVIORAL

PACT is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature

Parent Acceptance and Commitment Therapy (PACT)

Control BEHAVIORAL

The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Must be a parent aged 18+ (primary caregiver) of 2-6-year-old child with PFD
• \) Child must be receiving outpatient PFD treatment at Children's Mercy Hospital (CMH)
• \) 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

You may not qualify if:

• \) Parent has significant cognitive impairments
• \) Parent does not speak English
• Parent unable to obtain high speed internet at home

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Limitations and Caveats

The findings of this study should be interpreted with caution as this was a pilot study focused on feasibility, acceptability, and proof-of-concept in a small sample of families. Further research is needed to assess efficacy of this intervention through a large, appropriately powered randomized clinical trial.

Results Point of Contact

• Title: Dana Bakula, PhD
• Organization: Children's Mercy Kansas City

dmbakula@cmh.edu

(816) 302-3069

Study Officials

• Dana Bakula, PhD

  Children's Mercy Hosptial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 21, 2023
• Study Start: June 27, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)