Focused Acceptance and Commitment Therapy (FACT)
ConditionPediatric Feeding Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChildren's Mercy Hospital Kansas City
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
1) Parent has significant cognitive impairments
2) Parent does not speak English
3) Parent unable to obtain high speed internet at home
Trial design
Design model
Parallel
Treatments tested in this trial
FACT
BehavioralTwo 90-minute FACT sessions led by a trained interventionist.
Control
BehavioralTwo 90-minute sessions individually with a study interventionist, 2-weeks apart (focused on nutrition education).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: FACTExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Health Questionnaire 9 (PHQ-9)
A 9-item self-report measure of depressive symptoms. Scores of 10 or more indicate probable depression.
Time frame
Baseline, 2 weeks post-intervention completion, 3-months post-intervention2
General Anxiety Disorder (GAD-7)
A 7-item self-report measure of anxious symptoms. Scores of 10 or more indicate probable anxiety.
Time frame
Baseline, 2 weeks post-intervention completion, 3-months post-intervention3
The Parent Psychological Flexibility Questionnaire (PPFQ)
19-item measure of psychological flexibility that is specific to parenting behaviors
Time frame
Baseline, 2 weeks post-intervention completion, 3-months post-intervention4
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.
Time frame
Baseline, 2 weeks post-intervention completion, 3-months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Mercy Hospital Kansas City
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov