A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders

NCT05814653 | Enrolling By Invitation

• 2 other identifiers: 22-0118801R34MH128296-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders

Keywords

Children and Adolescents

Outcome Measures

Primary Outcomes (4)

• Rate of recruitment across 3 years

  Recruitment rate will be tracked, with a goal of enrollment of 75% of eligible participants.

  Rate of recruitment at end of study (3 years)

• Rate of retention across 3 years

  Retention rate will be tracked, with a target retention rate (attendance at \>80% of sessions) of 70%.

  Rate of retention at end of study (3 years)

• Mixed methods feedback survey at end of treatment (caregiver/patient)

  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.

  Assessed after the final session (within 6 months)

• Rate of retention across 3 years

  Rate of retention (defined as attendance at \> 80% of sessions) will be tracked, with a target of \<30% attrition.

  Rate of retention at end of study (3 years)

Secondary Outcomes (10)

• Parents versus Anorexia Scale (caregiver)

  Monthly across the intervention (up to 6 months)

• Parent Sense of Competency 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

Study Arms (2)

FBT-PC delivered by a primary care provider

EXPERIMENTAL

Subjects will receive up to 18 sessions of FBT-PC, delivered by a primary care provider, at their primary care clinic over 6 months.

Behavioral: Family Based Treatment-Primary Care

Standard FBT

ACTIVE COMPARATOR

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.

Behavioral: Family-Based Treatment

Interventions

Family Based Treatment-Primary Care BEHAVIORAL

Novel treatment that borrows key intervention strategies from standard family-based treatment. It uses trained primary care providers (PCPs), in consultation with a mental health provider, to deliver family-based treatment strategies in community-based clinics to increase caregiver self-efficacy to reverse their child's dietary restriction and weight loss.

Also known as: FBT-PC

FBT-PC delivered by a primary care provider

Family-Based Treatment BEHAVIORAL

Delivered by a mental health provider in a traditional mental health or eating disorder specialty setting. First-line evidence-based treatment for adolescent eating disorders that targets caregiver self-efficacy as a mechanism to facilitate weight restoration and ultimately symptom remission in adolescents.

Also known as: FBT

Standard FBT

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jocelyn Lebow, PhD, LP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: April 18, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)