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A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders

NCT05814653 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-02-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

Family Based Treatment-Primary Care

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.

BEHAVIORAL

Family-Based Treatment

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Jocelyn Lebow, PhD, LP · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05814653 on ClinicalTrials.gov