Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders

NCT05184556 | Active Not Recruiting DMC

• 2 other identifiers: STUDY22040112R34MH123589
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting, in the context of community-based mental health. Adolescents with AN-spectrum disorders (n=50) and their caregivers will be randomly assigned to either family-based treatment or integrated family therapy delivered in the home. Caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy, adolescent distress, and generalizability of treatment skills. Treatment feasibility, acceptability, and appropriateness will be measured among providers and participating families. The proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of psychological treatments for AN, including whether adapting them for the home setting may improve accessibility and effects on treatment outcome

Conditions

Anorexia Nervosa; Eating Disorders

Outcome Measures

Primary Outcomes (2)

• Body mass index percentile

  Adolescents will have their height and weight measured to calculate BMI percentile using CDC growth charts and accompanying procedures.

  Up to 32-weeks post randomization

• Eating Disorder Examination

  The Eating Disorder Examination will be used to diagnose anorexia nervosa, and assess eating disorder behaviors, attitudes, and cognitions. Items are scored from 0-7 and averaged to create subscales reflecting restraint, eating concerns, shape concerns, weight concerns, and global eating-related psychopathology. Higher scores indicate more severe eating disorder symptoms.

  Up to 32-weeks post randomization

Secondary Outcomes (10)

• Abbreviated Acceptability Rating Profile

  Up to 32-weeks post randomization

• Therapy Suitability and Patient Expectancy

  Up to 32-weeks post randomization

• Acceptability, Appropriateness, and Feasibility of Intervention Measure

  Up to 3 years

• Client Satisfaction Questionnaire

  Up to 32-weeks post randomization

• Multi-theoretical List of Therapeutic Interventions

  Up to 32-weeks post randomization

Other Outcomes (12)

• Subjective Units of Distress Scale

  Up to 32-weeks post randomization

• Parent vs. Anorexia Scale

  Up to 32 weeks post-randomization

• General Self Efficacy Scale

  Up to 32 weeks post-randomization

Study Arms (2)

Family-based treatment

EXPERIMENTAL

Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care

Behavioral: Family-based treatment (FBT)

Integrative family therapy

ACTIVE COMPARATOR

Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care

Behavioral: Integrative family therapy

Interventions

Family-based treatment (FBT) BEHAVIORAL

FBT is a structured behavioral treatment focused on empowering caregivers to take charge of the adolescent's eating behavior and return him/her to a normative weight and developmental trajectory. FBT involves three consecutive phases: 1) caregivers are fully in control of the adolescent's eating; 2) control of eating is gradually returned to the adolescent; and 3) developmental issues are explored. In the current study, FBT is adapted for delivery in the home setting in the following ways: intensified dose of treatment (2-6 hours of therapy per week over 10 - 32 weeks); use of clinician as an additional support to the family; multiple family meals in the home and community; sociocultural tailoring; and inclusion of supplemental individual work with the adolescent to improve emotion regulation/distress tolerance.

Family-based treatment

Integrative family therapy BEHAVIORAL

The integrated family therapy approach includes psychoeducation, supportive family therapy, and elements of cognitive-behavioral interventions. Families may be referred for additional nutritional counseling and prescribed a meal plan as indicated. Typical strategies include educating families on the presentation and prognosis of adolescent AN; identifying dysfunctional family structures/alliances and communication patterns; using reflective listening to engage and validate family members; challenging maladaptive beliefs about eating and weight; and supporting families in developing strategies for management of both general and eating disorder-specific distress. Treatment is generally non-directive.

Integrative family therapy

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Meets criteria for AN or atypical AN according to DSM-5 diagnostic criteria.
• Currently living at home with caregivers who are willing to engage in family treatment.
• Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute) and receiving medical monitoring from a clinician throughout treatment.
• If on psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication for a co-morbid condition.
• Available for follow-up.

You may not qualify if:

• Associated physical illness that necessitates hospitalization.
• Psychotic illness/other mental illness requiring hospitalization.
• Current dependence on drugs or alcohol.
• Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight.
• Concurrent involvement in other psychological treatment for an eating disorder.
• Developmental delay that would preclude participation in the intervention.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator
• Lifespan: collaborator
• Rhode Island College: collaborator

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Gateway Healthcare

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea B Goldschmidt, Ph.D.

  The University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 11, 2022
• Study Start: August 1, 2022
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be uploaded at least every 6 months for the duration of the 3-year study.
• Access Criteria: We will make data and documentation available only under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed; and (4) a commitment not to attempt to identify participants individually.

Locations

US (2)