NCT06630000 · Children's Mercy Hospital Kansas City
Focused Acceptance and Commitment Therapy (FACT)
(FACT)
What this study is about
This is a randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
FACT
Two 90-minute FACT sessions led by a trained interventionist.
BEHAVIORAL
Control
Two 90-minute sessions individually with a study interventionist, 2-weeks apart (focused on nutrition education).
Primary outcome measures
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
A 9-item self-report measure of depressive symptoms. Scores of 10 or more indicate probable depression.
General Anxiety Disorder (GAD-7)
Time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
A 7-item self-report measure of anxious symptoms. Scores of 10 or more indicate probable anxiety.
The Parent Psychological Flexibility Questionnaire (PPFQ)
Time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
19-item measure of psychological flexibility that is specific to parenting behaviors
Impact of Event Scale - Revised (IES-R)
Time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
A 22-item self-report measure of posttraumatic stress symptoms. Scores of 33 or more indicate clinically significant posttraumatic stress.
Perceived Stress Scale (PSS)
Time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
A 10-item self-report measure of perceived stress. Scores of 14 or more indicate clinically significant stress.
The Acceptance and Action Questionnaire (AAQ-2)
Time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
A 7-item self-report measure of psychological flexibility and experiential avoidance, which are targets of the behavioral treatment. Higher scores reflect more flexibility.
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
Time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
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.
Early Childhood Parent Report Global Health 8a
Time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
An 8 item parent proxy measure of child overall health and skills. Scores of 40 or higher indicate moderate to severe symptoms/impairment.
Early Childhood Parent Report Self-Regulation - Flexibility 5a
Time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
A 5 item parent proxy measure of a child's ability to adapt to change. Lower scores indicate less ability to adapt to change.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Kansas City, Missouri
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 15, 2026 · Source of record for eligibility and locations