ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-08-01
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05184556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets criteria for AN or atypical AN according to DSM-5 diagnostic criteria.
  2. * Currently living at home with caregivers who are willing to engage in family treatment.
  3. * 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.
  4. * If on psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication for a co-morbid condition.
  5. * Available for follow-up.
  1. * Associated physical illness that necessitates hospitalization.
  2. * Psychotic illness/other mental illness requiring hospitalization.
  3. * Current dependence on drugs or alcohol.
  4. * Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight.
  5. * Concurrent involvement in other psychological treatment for an eating disorder.
  6. * Developmental delay that would preclude participation in the intervention.

Contacts and Locations

Principal Investigator

Andrea B Goldschmidt, Ph.D.
PRINCIPAL_INVESTIGATOR
The University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Gateway Healthcare
Pawtucket, Rhode Island, 02860
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Andrea B Goldschmidt, Ph.D., PRINCIPAL_INVESTIGATOR, The University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Anorexia Nervosa
  • Eating Disorders