Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID (NCT04450771) | Clinical Trial Compass
CompletedNot Applicable
Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID
United States98 participantsStarted 2020-12-01
Plain-language summary
This study is examining the efficacy and mechanism of family therapy compared to usual care for children between the ages of 6 and 12 who are diagnosed with Avoidant/Restrictive Food Intake Disorder. Preliminary data suggest that family therapy is superior to usual care and that improvement in parental self-efficacy related to feeding their children is the mechanism of treatment. In addition, this study will attempt to identify specific patient groups who respond to family therapy.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children meeting DSM-V criteria for ARFID
* Children between the ages of 6 to 12 years old, living with their families
* Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine.
* Not engaging in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study.
* Less than 4 sessions of FBT
* If taking medication for co-morbid disorders, participants must be on a stable dose of medication for 8 weeks (2 months) before participating. If the participant is on a new medication at baseline, but is discontinuing the medication in order to start the study, they must have discontinued the medication before beginning treatment.
* EBW between 75% and 88%.
* Able to fluently speak and read English
Exclusion Criteria:
* Current physical, psychotic illness or other mental illness requiring hospitalization
* Current psychotic illness or mental retardation or other mental illnesses that would prohibit the use of psychotherapy
* Current dependence on drugs or alcohol
* Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
* Any medical complications or severe mental disorder (psychosis, low-functioning Autism) that may reduce compliance with the study procedures or require more intensive care to manage the symptoms
* 4 or more sessions of FBT
* Currently taking medication for co-morb…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Expected Body Weight (EBW)
Timeframe: Following 4 months of FBT-ARFID or NSC
2
Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID)
Timeframe: Following 4 months of FBT-ARFID or NSC
3
Parental Feeding Behavior Assessment
Timeframe: After week 6 of either arm in all participants.