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

Study Overview
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Brief Summary
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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
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Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders

Conditions
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Anorexia Nervosa, Eating Disorders

Intervention / Treatment
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* Behavioral: Family-based treatment (FBT)
* Behavioral: Integrative family therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family-based treatment<br>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)<br>* 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.<br>|
| Active Comparator: Integrative family therapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 24-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 24-weeks post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abbreviated Acceptability Rating Profile | 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. | Up to 24-weeks post randomization | 
| Therapy Suitability and Patient Expectancy | 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. | Up to 24-weeks post randomization | 
| Acceptability, Appropriateness, and Feasibility of Intervention Measure | 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. | Up to 3 years | 
| Client Satisfaction Questionnaire | 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. | Up to 24-weeks post randomization | 
| Multi-theoretical List of Therapeutic Interventions | 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. | Up to 24-weeks post randomization | 
| Therapeutic Technique Scale | 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. | Up to 3 years | 
| Engagement | Percentage of potentially eligible families offered treatment who ultimately engaged in a baseline assessment visit. | Up to 3 years | 
| Enrollment | Percentage of potentially eligible families who ultimately enroll in the treatment. | Up to 3 years | 
| Attendance | Number of therapy sessions completed. | Up to 24-weeks post randomization | 
| Completion | Percentage of families who complete a course of treatment without terminating or being withdrawn prematurely. | Up to 24-weeks post randomization |