Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 4
- 主要终点
- Body mass index percentile
研究概览
简要总结
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
详细描述
Participants (adolescents with AN-spectrum and their parents) are asked to complete study assessments at 5 time points: baseline and 6-, 12-, 24-, and 32-weeks after starting treatment. The 32-week time point was added approximately a year into the study, at the suggestion of the Program Officer. The research team noted that some families are still in treatment at the time of the 24-week assessment, so these data do not capture post-treatment thoughts and behaviors. To better assess post-treatment outcomes, a 32-week assessment was added to protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Family-based treatment
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
干预措施: Family-based treatment (FBT) (Behavioral)
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
干预措施: Integrative family therapy (Behavioral)
结局指标
主要结局
Body mass index percentile
时间窗: Up to 32-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
时间窗: Up to 32-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.
次要结局
- Acceptability, Appropriateness, and Feasibility of Intervention Measure(Up to 3 years)
- Therapeutic Technique Scale(Up to 3 years)
- Engagement(Up to 3 years)
- Enrollment(Up to 3 years)
- 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)
- Multi-theoretical List of Therapeutic Interventions(Up to 32-weeks post randomization)
- Therapeutic Technique Scale(Up to 3 years)
- Engagement(Up to 3 years)
- Client Satisfaction Questionnaire(Up to 32-weeks post randomization)
- Enrollment(Up to 3 years)
- Attendance(Up to 32-weeks post randomization)
- Completion(Up to 32-weeks post randomization)
研究者
Andrea Goldschmidt
Associate Professor
University of Pittsburgh