A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders (NCT05814653) | Clinical Trial Compass
By InvitationNot Applicable
A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders
United States200 participantsStarted 2023-09-01
Plain-language summary
The purpose of this study is to test the feasibility of a RCT of a new treatment for children and adolescents with eating disorders characterized by dietary restriction and/or weight loss or failure to gain expected weight. The treatment, which is called Family-Based Treatment for Primary Care (or FBT-PC for short), is based on Family-Based Treatment, the gold standard outpatient eating disorder treatment for children and adolescents.
Who can participate
Age range
7 Years – 18 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:
* Diagnosis of a DSM-5 restrictive eating disorder (anorexia nervosa or other specified feeding or eating disorder characterized by dietary restriction and/or weight loss or failure to make expected weight gains).
* Eligible patients will have at least one caregiver who is also willing to participate in the study.
* Eligible patients must receive primary care through the MCHS
Exclusion Criteria:
* Patients will be excluded who have received FBT in the past, and/or who report active suicidality.
* Patients who become physically or psychiatrically unstable during the study will be re-evaluated and referred for appropriate treatment.
* Patients will be excluded if their enrolled caregiver has active substance dependence, mental health concerns that make it difficult to engage in treatment, or are perpetrators of abuse.
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
Rate of recruitment across 3 years
Timeframe: Rate of recruitment at end of study (3 years)
2
Rate of retention across 3 years
Timeframe: Rate of retention at end of study (3 years)
3
Mixed methods feedback survey at end of treatment (caregiver/patient)
Timeframe: Assessed after the final session (within 6 months)
4
Rate of retention across 3 years
Timeframe: Rate of retention at end of study (3 years)