Recruiting

FACT

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT06630000

Conditions

Pediatric Feeding Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FACT

Control

Study Details

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

Study ID

NCT06630000

Start date

Oct 14, 2024

Status verified date

Jan, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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
  • 3\) Parent unable to obtain high speed internet at home

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FACT

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

active comparator: Control

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

Interventions

FACT

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

Control

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

Primary outcome measure

  • Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention ]
  • General Anxiety Disorder (GAD-7) [ Time Frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention ]
  • The Parent Psychological Flexibility Questionnaire (PPFQ) [ Time Frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention ]
  • Impact of Event Scale - Revised (IES-R) [ Time Frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention ]
  • Perceived Stress Scale (PSS) [ Time Frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention ]
  • The Acceptance and Action Questionnaire (AAQ-2) [ Time Frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention ]
  • Behavioral Pediatrics Feeding Assessment Scale (BPFAS) [ Time Frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention ]
  • Early Childhood Parent Report Global Health 8a [ Time Frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention ]
  • Early Childhood Parent Report Self-Regulation - Flexibility 5a [ Time Frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention ]

Central Contacts and Locations

Central contacts

Corey Schurman

8163023076crschurman@cmh.edu

Locations

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Corey Schurman

816-569-6053coreyschurman@yahoo.com

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Keywords

  • Feeding
  • Mental Health
  • Parents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-01-15.