Evaluating the Feasibility of a Primary Care-based Treatment for Restrictive Eating Disorders in Children and Adolescents in the Health System
Overview
- Phase
- N/A
- Intervention
- Family Based Treatment-Primary Care
- Conditions
- Eating Disorders
- Sponsor
- Mayo Clinic
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Rate of recruitment across 3 years
- Status
- Enrolling by Invitation
- Last Updated
- 2 months ago
Overview
Brief 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.
Detailed Description
In the United States, half a million adolescents suffer from an eating disorder. With only 66 certified providers nationally, Family-Based Treatment (FBT), a first-line evidence-based treatment for adolescent eating disorders, is not readily available to most families. This provider shortage leaves most young patients without care and undoubtedly contributes to the chronicity and lethality of these conditions. Patients with eating disorders generally make their first contact with the healthcare system in primary care. As such, equipping primary care providers (PCPs) with effective means to treat these patients has potential to democratize care, improve rates of early intervention, and enhance patient outcomes. Family-Based Treatment for Primary Care (FBT-PC) is a novel intervention for delivery by a PCP in primary care that uses FBT strategies. Data support proof-of-concept for this adaptation. This study has several study aims. (1) Finalize the FB-PC intervention through an open case series. (2) Establish the feasibility and acceptability of FBT-PC for caregivers, patients, and PCPs in a pilot randomized controlled trial. Finally, (3) to test preliminary target engagement of FBT-PC and determine whether it is associated with improved caregiver self-efficacy and, through this mechanism, symptom remission. Remission will be defined as weight restoration to 95% of expected body weight and a score within 1 SD of community norms on the Eating Disorder Examination-Questionnaire. In addition, as (4) an exploratory aim analyses will be conducted to evaluate baseline characteristics of the sample to determine for whom the FBT-PC intervention is most beneficial. To accomplish all aims an open case series (n = 6) will be conducted, followed by a pilot trial in which 40 patients (ages 7-18 years) with restrictive eating disorders and their caregiver(s) will be randomly assigned to FBT-PC or a control condition of standard FBT. Families will attend up to 18 sessions over 6 months. Goals from the open case series (Aim 1) will include the development of tools for FBT-PC training and implementation, including treatment and training protocols and fidelity measures. Feasibility (Aim 2) will be assessed through an evaluation of recruitment and retention. Acceptability (Aim 2) will be evaluated using mixed methods surveys and interviews of caregivers, patients and PCPs on the topics of tolerability, fit, and burden. The degree to which FBT-PC engages the proposed mechanism of change, caregiver self-efficacy, to facilitate symptom remission will also be assessed (Aim 3). Effect sizes will be calculated for FBT-PC with a goal of ≥ 0.5, comparable with those found in FBT trials. Finally, baseline sample characteristics (Exploratory Aim) will be assessed including caregiver perceptions about their child's illness, referral method, length of illness, and symptom severity. Once feasibility, acceptability, and target engagement of the FBT-PC intervention have been established, these findings will be used in support of a large pragmatic clinical trial to evaluate the noninferiority of effectiveness of FBT-PC versus standard FBT.
Investigators
Jocelyn R. Lebow
Principal Investigator
Mayo Clinic
Eligibility Criteria
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.
Arms & Interventions
FBT-PC delivered by a primary care provider
Subjects will receive up to 18 sessions of FBT-PC, delivered by a primary care provider, at their primary care clinic over 6 months.
Intervention: Family Based Treatment-Primary Care
Standard FBT
Subjects will receive up to 18 session of FBT, delivered by a specialist mental health provider at Mayo Clinic in Rochester, MN over 6 months.
Intervention: Family-Based Treatment
Outcomes
Primary Outcomes
Rate of recruitment across 3 years
Time Frame: Rate of recruitment at end of study (3 years)
Recruitment rate will be tracked, with a goal of enrollment of 75% of eligible participants.
Mixed methods feedback survey at end of treatment (caregiver/patient)
Time Frame: Assessed after the final session (within 6 months)
This is a unique survey with quantitative (Likert scale rating/ yes/no questions) and qualitative (short answer) questions that assesses treatment satisfaction, acceptability of session frequency, length, and therapeutic alliance, as well as comfort and familiarity with treatment intervention components. Higher scores on Likert scales indicate greater satisfaction/acceptability.
Rate of retention across 3 years
Time Frame: Rate of retention at end of study (3 years)
Retention rate will be tracked, with a target retention rate (attendance at \>80% of sessions) of 70%.
Secondary Outcomes
- Parent Sense of Competency Scale (caregiver)(Monthly across the intervention (up to 6 months))
- Parents versus Anorexia Scale (caregiver)(Monthly across the intervention (up to 6 months))
- Eating Disorder Symptom Reduction (patient)(Pre/post intervention (up to 6 months))
- Internalized Stigma of Mental Illness Scale (caregiver/patient)(Pre/post intervention (up to 6 months))
- Treatment experience feedback survey- Year 1 (provider)(End of Year 1 of the study)
- Treatment experience feedback survey- Year 2 (provider)(End of Year 2 of the study)
- Qualitative treatment experience feedback interview- Year 1 (provider)(End of Year 1 of the study)
- Qualitative treatment experience feedback interview- Year 2 (provider)(End of Year 2 of the study)
- Qualitative treatment experience feedback interview (caregiver)(At the end of their study participation (up to 6 months))
- Qualitative treatment experience feedback interview (patient)(At the end of their study participation (up to 6 months))