Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
- Conditions
- Anorexia NervosaEating Disorders
- Interventions
- Behavioral: Family-based treatment (FBT)Behavioral: Integrative family therapy
- Registration Number
- NCT05184556
- Lead Sponsor
- University of Pittsburgh
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Family-based treatment Family-based treatment (FBT) 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 Integrative family therapy Integrative family therapy 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
- Primary Outcome Measures
Name Time Method Body mass index percentile Up to 24-weeks post randomization Adolescents will have their height and weight measured to calculate BMI percentile using CDC growth charts and accompanying procedures.
Eating Disorder Examination Up to 24-weeks post randomization 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.
- Secondary Outcome Measures
Name Time Method Attendance Up to 24-weeks post randomization Number of therapy sessions completed.
Completion Up to 24-weeks post randomization Percentage of families who complete a course of treatment without terminating or being withdrawn prematurely.
Abbreviated Acceptability Rating Profile Up to 24-weeks post randomization The Abbreviated Acceptability Rating Profile is an 8-item questionnaire that assesses acceptability of treatment from both parent and child viewpoints on a 6-point Likert scale. Higher scores reflect greater levels of treatment acceptability.
Therapeutic Technique Scale Up to 3 years The Therapeutic Technique Scale assesses clinician implementation of 17 therapeutic techniques to measure treatment fidelity. Items are rated from 0-5, with higher scores indicating a greater level of skill in implementing each therapeutic technique in therapy sessions.
Enrollment Up to 3 years Percentage of potentially eligible families who ultimately enroll in the treatment.
Therapy Suitability and Patient Expectancy Up to 24-weeks post randomization The Therapy Suitability and Patient Expectancy is used to assess patients' and caregivers' perceptions of treatment suitability and expected improvement with treatment from 0 (not at all) to 10 (extremely) using 2 items. Higher scores reflect more positive expectations from treatment.
Multi-theoretical List of Therapeutic Interventions Up to 24-weeks post randomization The Multi-theoretical List of Therapeutic Interventions assesses different therapeutic techniques occurring across different forms of psychotherapy. The MULTI-60 comprises 8 subscales representing 8 primary therapeutic orientations, including cognitive-behavioral and dialectic-behavioral therapy. Items are rated from 1-5, with higher scores indicating that a given technique is more typical of the overall treatment approach.
Engagement Up to 3 years Percentage of potentially eligible families offered treatment who ultimately engaged in a baseline assessment visit.
Acceptability, Appropriateness, and Feasibility of Intervention Measure Up to 3 years The Acceptability, Appropriateness, and Feasibility of Intervention Measure is a 31-item survey comprising three subscales (acceptability, appropriateness, and feasibility) that will assess clinician perspectives of treatment. Higher scores reflect greater perceived acceptability, appropriateness, and feasibility.
Client Satisfaction Questionnaire Up to 24-weeks post randomization The Client Satisfaction Questionnaire-8 is an 8-item questionnaire that assesses satisfaction with treatment on a 4-point Likert scale, with higher scores indicating higher treatment satisfaction.
Trial Locations
- Locations (3)
The Providence Center
🇺🇸Providence, Rhode Island, United States
Gateway Healthcare
🇺🇸Pawtucket, Rhode Island, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States