Focused Acceptance and Commitment Therapy (FACT)

NCT06630000 | Recruiting

• 2 other identifiers: STUDY00003127K23MH133874
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial of Focused Acceptance and Commitment Therapy (FACT) 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: FACT 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 FACT 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 three times during study. Researchers will compare the FACT group with a control group to see if FACT will result in clinically meaningful change in parent stress and anxiety, and parent use of positive mealtime behaviors.

Conditions

Pediatric Feeding Disorders

Keywords

Feeding; Mental Health; Parents

Outcome Measures

Primary Outcomes (9)

• Patient Health Questionnaire 9 (PHQ-9)

  A 9-item self-report measure of depressive symptoms. Scores of 10 or more indicate probable depression.

  Baseline, 2 weeks post-intervention completion, 3-months post-intervention

• General Anxiety Disorder (GAD-7)

  A 7-item self-report measure of anxious symptoms. Scores of 10 or more indicate probable anxiety.

  Baseline, 2 weeks post-intervention completion, 3-months post-intervention

• The Parent Psychological Flexibility Questionnaire (PPFQ)

  19-item measure of psychological flexibility that is specific to parenting behaviors

  Baseline, 2 weeks post-intervention completion, 3-months post-intervention

• Impact of Event Scale - Revised (IES-R)

  A 22-item self-report measure of posttraumatic stress symptoms. Scores of 33 or more indicate clinically significant posttraumatic stress.

  Baseline, 2 weeks post-intervention completion, 3-months post-intervention

• Perceived Stress Scale (PSS)

  A 10-item self-report measure of perceived stress. Scores of 14 or more indicate clinically significant stress.

  Baseline, 2 weeks post-intervention completion, 3-months post-intervention

• The Acceptance and Action Questionnaire (AAQ-2)

  A 7-item self-report measure of psychological flexibility and experiential avoidance, which are targets of the behavioral treatment. Higher scores reflect more flexibility.

  Baseline, 2 weeks post-intervention completion, 3-months post-intervention

• Behavioral Pediatrics Feeding Assessment Scale (BPFAS)

  A 7-item self-report measure of psychological flexibility and experiential avoidance, which are targets of the behavioral treatment. Higher scores reflect higher probability of feeding disorder.

  Baseline, 2 weeks post-intervention completion, 3-months post-intervention

• Early Childhood Parent Report Global Health 8a

  An 8 item parent proxy measure of child overall health and skills. Scores of 40 or higher indicate moderate to severe symptoms/impairment.

  Baseline, 2 weeks post-intervention completion, 3-months post-intervention

• Early Childhood Parent Report Self-Regulation - Flexibility 5a

  A 5 item parent proxy measure of a child's ability to adapt to change. Lower scores indicate less ability to adapt to change.

  Baseline, 2 weeks post-intervention completion, 3-months post-intervention

Study Arms (2)

FACT

EXPERIMENTAL

Behavioral: Focused Acceptance and Commitment Therapy (FACT) FACT is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature

Behavioral: FACT

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

FACT BEHAVIORAL

Two 90-minute FACT sessions led by a trained interventionist.

FACT

Control BEHAVIORAL

Two 90-minute sessions individually with a study interventionist, 2-weeks apart (focused on nutrition education).

Control

Eligibility Criteria

• Age: 18 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 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 Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Corey Schurman

CONTACT

8163023076; crschurman@cmh.edu

Study Design

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

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)