Clinical trial NCT06630000: Focused Acceptance and Commitment Therapy (FACT)
Official title: Focused Acceptance and Commitment Therapy (FACT) for Parents of Children With Pediatric Feeding Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Feeding Disorders
Keywords: Feeding
Mental Health
Parents
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
measure: General Anxiety Disorder (GAD-7)
timeFrame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
measure: The Parent Psychological Flexibility Questionnaire (PPFQ)
timeFrame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
measure: Impact of Event Scale - Revised (IES-R)
timeFrame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
measure: The Acceptance and Action Questionnaire (AAQ-2)
timeFrame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
measure: Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
timeFrame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
measure: Early Childhood Parent Report Global Health 8a
timeFrame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
measure: Early Childhood Parent Report Self-Regulation - Flexibility 5a
timeFrame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References: