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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Corey Schurman, 816-569-6053, coreyschurman@yahoo.com
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).
- Conditions
- Pediatric Feeding Disorders
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: FACT |
| Control | Active comparator | The 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.
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
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
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
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
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
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
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
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
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.
- First posted8 Oct 2024
- Study start14 Oct 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Feeding DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dana Bakula, Children's Mercy Hospital Kansas City
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Acceptance and Commitment Therapy (FACT) for Parents of Children With Pediatric Feeding Disorder
- ClinicalTrials.gov ID
- NCT06630000
- Acronym / sponsor ID
- FACT / STUDY00003127
- Conditions
- Pediatric Feeding Disorders
- Keywords
- Feeding, Mental Health, Parents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FACT | Experimental | Behavioral: FACTBehavioral: Focused Acceptance and Commitment Therapy (FACT) FACT is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature |
| Control | Active comparator | Behavioral: ControlThe content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 1) Parent has significant cognitive impairments
- 2) Parent does not speak English
- 3) Parent unable to obtain high speed internet at home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FACTTwo 90-minute FACT sessions led by a trained interventionist. | Behavioural | FACT |
| ControlTwo 90-minute sessions individually with a study interventionist, 2-weeks apart (focused on nutrition education). | Behavioural | Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Pediatric Feeding Disorders
RecruitingObservational study
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Not yet recruitingObservational study
Enteral Feeding in Mechanically Ventilated Children
Critical Illness, Mechanical Ventilation Complication
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Active, not recruitingEarly Phase 1
Naltrexone Neuroimaging in Teens With Eating Disorders
Eating Disorders, Binge Eating
Enrolling by invitation
Deimplementation of Inappropriate Feeding Practices in Early Care and Education Settings
Obesity, Childhood
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.