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Pediatric Feeding DisordersFACTNCT06630000

Focused Acceptance and Commitment Therapy (FACT)

A study testing FACT in people with Pediatric Feeding Disorders, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pediatric Feeding Disorders
What is being tested?
FACT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
14 Oct 2024to 1 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 1) Parent has significant cognitive impairments
  • 2) Parent does not speak English
  • 3) Parent unable to obtain high speed internet at home

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Corey Schurman contact

8163023076

crschurman@cmh.edu

United States1 site, 1 recruiting
  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

    Corey Schurman, 816-569-6053, coreyschurman@yahoo.com

    Recruiting

Other trials in United States

About this study

Official title: Focused Acceptance and Commitment Therapy (FACT) for Parents of Children With Pediatric Feeding Disorder

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.

Read more

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.

Read the detailed description

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 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 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 Focused Acceptance and Commitment Therapy (FACT) for Parents of Children with Pediatric Feeding Disorder. The ultimate goal of this research is to improve parent mental health and child health and feeding outcomes through a parent-focused behavioral intervention.

FACT is a 2-session acceptance and commitment therapy (ACT) intervention guided by Brown and Whittingham's ACT intervention for parents of children with neurodevelopmental conditions. Intervention content is based on principles of ACT, an evidence-based treatment for adult mental health problems. The intervention content is therefore broadly applicable to all parents but was specifically tailored for the needs of parents of children with neurodevelopmental conditions. In study phase 1 of this award, the investigators adapted parent ACT for parents of children with pediatric feeding disorder (PACT-F) with consultation from 2 parents of children with pediatric feeding disorder and 2 experts in parent ACT. The investigators now have a complete treatment package that has been tailored for parents of children with pediatric feeding disorder and is ready to be piloted.

This study will be conducted at a single site (Children's Mercy Hospital). The investigators will implement the clinical trial procedures and monitor feasibility success, and factors that may impact feasibility success. Participants who meet inclusion criteria will be randomized to either FACT or an attention control (control) condition. Participants will be blind to treatment condition (single blind study). The aim of the feasibility analyses is to evaluate factors critical to success, rather than evaluating whether the intervention is "feasible or not feasible". The aim of the proof-of-concept analyses is to determine if this intervention has promise and warrants a larger efficacy trial.

Parents randomized to FACT will complete two 90-minute FACT sessions individually with a study interventionist, 2 weeks apart. Parents randomized to the control group will complete two 90-minute sessions individually with a study interventionist, 2-weeks apart (focused on nutrition education). The control intervention will be parallel to the ACT intervention in all ways, including interactive components and the face-to-face time with health professionals (interventionists). The control condition intervention has already been developed by Dr. Davis's research team and covers a range of nutrition and healthy lifestyle topics including the United States Department of Agriculture's (USDA) MyPlate. An attention control condition was selected to mimic the interpersonal benefits that may come from meeting individually with a caring professional. The control condition intervention content (healthy lifestyles) was specifically chosen as it most closely reflects the types of information that parents would learn from healthcare professionals about the type of nutrition that their child needs. However, this type of intervention should not impact parent mental health.

Interventionists for both conditions will be individuals with at least master's degree training in mental health or a related field. The interventions will take via tele-video conferencing to allow participants to participate from home without needing transportation to and from the hospital. Both arms of the intervention will be manualized and interventionists in both arms will be trained using didactics and role playing with the Principle Investigator(PI). Intervention fidelity will be monitored by audio/video recording all sessions. The PI (Dr. Bakula) will review recordings each week and conduct separate 1-hour weekly supervision of study interventionists for each arm of the study (FACT \& control).

Strategies will be used to promote fidelity in line with recommendations from the NIH Behavior Change Consortium. A fidelity checklist will be developed in line with adaptations to the intervention and will be piloted with study interventionists. The fidelity checklist will be refined during research team meetings. The fidelity checklist will be reviewed by the PI during supervision.

Hypothesis testing: The investigators will test the hypothesis that FACT results in clinically meaningful change using the Reliable Change Index (RCI; success defined as RCI > 1.96). The investigators anticipate that these procedures will be feasible, with feasibility success defined as recruitment rate above 60%, and retention, assessment completion, and intervention completion rate above 80%. Mixed methods data collection will identify factors that impact 1) recruitment rate (qualitative interviews, % meeting inclusion criteria, # of contact attempts), 2) retention rates (qualitative interviews, baseline characteristics; treatment group), 3) assessment completion rate (qualitative interviews, measure type), and 4) treatment completion rate (qualitative interviews, scheduling, treatment location).

Being tested
FACT, Control
Keywords
Feeding, Mental Health, Parents
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FACTBehavioural

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

  • ControlBehavioural

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

Study groups in NCT06630000
Study groupRoleWhat they receive
FACTExperimentalBehavioral: Focused Acceptance and Commitment Therapy (FACT) FACT is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature
Receives: Behavioral: FACT
ControlActive comparatorThe content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire 9 (PHQ-9)

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

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

  2. General Anxiety Disorder (GAD-7)

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

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

  3. The Parent Psychological Flexibility Questionnaire (PPFQ)

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

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

  4. 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.

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

  5. Perceived Stress Scale (PSS)

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

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start14 Oct 2024
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630000
Sponsor's protocol ID
STUDY00003127
Other IDs
K23MH133874
Acronym
FACT
Status last verified
Jan 2026
First submitted
4 Oct 2024
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FACT in people with Pediatric Feeding Disorders, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Corey Schurman (8163023076, crschurman@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire 9 (PHQ-9) (time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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