Parent Acceptance and Commitment Therapy for Pediatric Feeding Disorder

(PACT Trial)

Overseen By Corey R Schurman, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Cognitive impairments, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

73 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on therapy for parents, so it's unlikely to require changes to your medication, but you should confirm with the trial organizers.

What data supports the effectiveness of Parent Acceptance and Commitment Therapy (PACT) for Pediatric Feeding Disorder?

Research shows that behavioral interventions can significantly improve feeding behaviors in children with feeding disorders. Additionally, addressing parent mental health, which PACT may help with, is important as it can influence mealtime interactions and outcomes. ^{1 2 3 4 5}

Is Parent Acceptance and Commitment Therapy (PACT) safe for children with feeding disorders?

There is no specific safety data available for Parent Acceptance and Commitment Therapy (PACT) in the context of pediatric feeding disorders from the provided research articles. ^{1 6 7 8 9}

How does Parent Acceptance and Commitment Therapy (PACT) differ from other treatments for pediatric feeding disorder?

Parent Acceptance and Commitment Therapy (PACT) is unique because it focuses on improving the mental health and stress levels of parents, which can positively influence their interactions with their children during mealtime. This approach is different from traditional behavioral interventions that primarily target the child's feeding behavior. ^{1 2 4 5 8}

Research Team

Dana Bakula, Phd

Principal Investigator

Children's Mercy Hosptial

Eligibility Criteria

This trial is for parents over 18 years old who are the primary caregivers of children aged 2-6 with Pediatric Feeding Disorder (PFD), receiving treatment at Children's Mercy Hospital. Parents must show significant stress or mental health issues but can't have cognitive impairments, language barriers, or lack internet access.

Inclusion Criteria

My child is getting outpatient PFD treatment at 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

I am the main caregiver for a child aged 2-6 with feeding difficulties.

Exclusion Criteria

Parent has significant cognitive impairments

My parent does not speak English.

Parent unable to obtain high speed internet at home

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PACT-F or a control intervention, each consisting of two 90-minute sessions conducted via tele-video conferencing, 2 weeks apart

4 weeks

2 sessions (virtual)

Follow-up

Participants are monitored for changes in mental health and child feeding outcomes, with assessments at baseline, 2 weeks post-intervention, and 3 months post-intervention

3 months

Treatment Details

Interventions

• Control
• Parent Acceptance and Commitment Therapy (PACT)

Trial Overview The study tests Parent Acceptance and Commitment Therapy (PACT) against a control group to see if it helps reduce mental health problems in these parents. It involves attending programs, filling out questionnaires, and recording meal times with their child.

Participant Groups

Group I: Parent Acceptance and Commitment Therapy (PACT) Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Feeding/Eating problems in children: Who does (not) benefit after behavior therapy? A retrospective chart review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Pediatric feeding disorders: a quantitative synthesis of treatment outcomes. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Using descriptive assessment in the treatment of bite acceptance and food refusal. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

ARFID Parent Training Protocol: A randomized pilot trial evaluating a brief, parent-training program for avoidant/restrictive food intake disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Parent Mental Health Problems in an Interdisciplinary Feeding Clinic: Short Communication. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Protocol for a randomized clinical trial for Avoidant Restrictive Food Intake Disorder (ARFID) in low-weight youth. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Interventions to reduce behavioral problems in children with cerebral palsy: an RCT. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Pediatric Feeding Disorder: A Nationwide Prevalence Study. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

Behavioral Therapy for Children with Avoidant/Restrictive Food Intake Disorder Dependent on Tube or Oral Enteral Nutrient Formula: A Feasibility Study. [2022]