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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two different programs might assist parents of children with pediatric feeding disorders. One group will participate in Parent Acceptance and Commitment Therapy (PACT), which aims to enhance mental health by teaching stress-reduction techniques. The other group will receive standard advice on nutrition and healthy lifestyles. Researchers aim to determine if PACT can reduce parent stress and improve mealtime interactions. Parents who may be suitable are those caring for a young child (ages 2-6) treated for a feeding disorder at Children's Mercy Hospital and experiencing significant stress. As an unphased study, this trial provides parents the chance to explore innovative support methods for managing stress and improving family dynamics.

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 prior data suggests that Parent Acceptance and Commitment Therapy (PACT) is safe for parents of children with pediatric feeding disorders?

Research shows that Parent Acceptance and Commitment Therapy (PACT) can help parents manage stress and improve mental health. Although specific safety data for PACT with parents of children with feeding disorders is unavailable, similar therapies have been studied. These studies indicate that such therapies can lower stress levels in parents. For instance, one study found that a mother's stress level dropped from high to average after treatment.

As a type of talk therapy, PACT generally poses a low risk of harm. Studies have reported no negative effects from PACT, suggesting it is well-tolerated. However, since this method is new for parents of children with feeding disorders, discussing any concerns with the research team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Parent Acceptance and Commitment Therapy (PACT) for pediatric feeding disorders because it introduces a novel approach by focusing on psychological flexibility in parents. Unlike standard treatments that primarily address dietary modifications or behavioral interventions for the child, PACT empowers parents through a two-session intervention based on Focused Acceptance and Commitment Therapy. This method may enhance parents' ability to manage stress and support their child's feeding development, potentially leading to more sustainable outcomes.

What evidence suggests that Parent Acceptance and Commitment Therapy (PACT) could be effective for improving mental health in parents of children with pediatric feeding disorders?

This trial will compare Parent Acceptance and Commitment Therapy (PACT) with a control intervention. Research has shown that PACT can reduce stress and improve mental health for parents of children with feeding problems. Studies have found that this therapy helps parents manage their emotions and address the challenges of their child's condition. Parents who tried similar therapies reported feeling less stressed and more capable of handling mealtime issues. Previous research suggests that PACT can significantly enhance parents' mental health and quality of life. These findings strongly indicate that PACT can be beneficial for parents facing these challenges. ^{4 6 7 8 9}

Who Is on the Research Team?

Dana Bakula, Phd

Principal Investigator

Children's Mercy Hosptial

Are You a Good Fit for This Trial?

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

Parent unable to obtain high speed internet at home

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. journals.sagepub.com journals.sagepub.com/doi/abs/10.1037/cpp0000549

Acceptance and Commitment Therapy for a Parent of ... Acceptance and commitment therapy (ACT) holds great promise for addressing parent stress among parents of children with PFD.

2. publications.aap.org publications.aap.org/pediatrics/article/156/4/e2025071134/204188/Acceptance-and-Commitment-Therapy-for-Parents-of

Acceptance and Commitment Therapy for Parents of ... The primary outcomes were parental psychological distress and QoL. Secondary outcomes were parental experience of child's illness, experiential ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06001398/parent-acceptance-and-commitment-therapy-pact-for-parents-of-children-with-pediatric-feeding-disorder

Parent Acceptance and Commitment Therapy (PACT) for ... 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06630000

Focused Acceptance and Commitment Therapy (FACT) This is a randomized clinical trial of Focused Acceptance and Commitment Therapy (FACT) vs. an attention-control condition (placebo) for improving the ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40969571/

Acceptance and Commitment Therapy for a Parent of ... Conclusions: Brief treatment of parental stress, offered in a pediatric treatment setting is feasible to implement and may have clinical utility in supporting ...

6. trialx.com trialx.com/clinical-trials/listings/296669/focused-acceptance-and-commitment-therapy-fact/

Focused Acceptance and Commitment Therapy (FACT) The goal of this study is to advance the science of a brief parent mental health intervention for parents of children with pediatric feeding ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12182011/

Parenting Acceptance and Commitment Therapy Online ... The primary outcome is observed emotional availability within parent–child interactions assessed at postintervention (12 weeks postbaseline) ...

8. withpower.com withpower.com/trial/phase-feeding-and-eating-disorders-5-2023-7de17

Parent Acceptance and Commitment Therapy for Pediatric ... Is Parent Acceptance and Commitment Therapy (PACT) safe for children with feeding disorders? There is no specific safety data available for Parent ...

9. read.qxmd.com read.qxmd.com/read/40969571/acceptance-and-commitment-therapy-for-a-parent-of-a-child-with-pediatric-feeding-disorder-a-case-study

Acceptance and Commitment Therapy for a Parent of ... RESULTS: This mother's stress improved from high to average over the course of treatment, using the parental stress scale. The majority of her improvements in ...