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Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID

NCT04450771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

  • Avoidant/Restrictive Food Intake Disorder

Interventions

BEHAVIORAL

Family-based Treatment for ARFID

This treatment includes 14 1-hour sessions that will be conducted approximately weekly over a 4 month period. It is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior.

BEHAVIORAL

Manualized Non-Specific Usual Care for ARFID

This treatment is a manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model. It consists of sessions with the child alone and 5 parent-only meetings, all of which are 1-hour over a 4 month period.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Stanford University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2025-07-13
Completion
2026-01-16

Countries

  • United States

Study Locations

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Entities

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 NCT04450771 on ClinicalTrials.gov