Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Estimated Body Weight (EBW)
研究概览
简要总结
The investigators are conducting a randomized controlled trial using an adaptive design for adolescents (ages 12-18) with anorexia nervosa to compare standard Family Based Treatment (FBT) to adaptive FBT with an Intensive Parental Coaching (IPC) component. If participants do not reach expected milestones by session 4 of treatment, participants may be randomized to receive additional IPC or continue treatment as usual with regular FBT.
详细描述
Potential subjects aged 12 to 18 with anorexia nervosa (AN) will be recruited from Stanford University, University of California, San Francisco, other bay-area medical programs and clinics, and online advertisement to the population at large. If participants are deemed eligible, participants will be invited for a baseline interview (about 2 hours in duration) during which the investigators will conduct interviews and collect questionnaire measures. Then, participants and participants' families will begin Family Based Treatment (FBT) with a study therapist at Stanford University or University of California, San Francisco, respectively. All assessments and treatments are conducted through tele-health.
At session 4, if participants have not gained 2.4kg, an indicator of early treatment response, participants and participants' families will be randomized to receive either treatment as usual (FBT) or an adaptive form of FBT, during which families will receive additional Intensive Parental Coaching (IPC). If participants have reached weight milestones (i.e., 2.4kg at session 4), participants will continue FBT as usual.
At 3 months of treatment and end of treatment, the investigators will collect the same measures taken at baseline. The investigators also ask that families participate in 6- and 12-month follow-up, respectively.
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
- Double (Investigator, 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
- 否
入选标准
- •12-18 years of age and living with participants' families
- •meeting DSM-5 criteria for AN (both subtypes) except for the amenorrhea requirement
- •medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine.
排除标准
- •associated physical illness that necessitates hospitalization
- •psychotic illness, mental retardation, or any other mental illnesses that would prohibit the use of psychotherapy
- •current dependence on drugs or alcohol
- •physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
- •previous FBT
- •currently taking medication for co-morbid disorders that cannot be safely discontinued on a stable dose for less than 2 months
- •in the case of patients with current, or a history of sexual or physical abuse by family members, perpetrators of the abuse will be excluded from treatment.
结局指标
主要结局
Estimated Body Weight (EBW)
时间窗: following 9 months of treatment
individual with anorexia nervosa's body weight at end of treatment
次要结局
未报告次要终点
研究者
James Dale Lock
MD, PhD
Stanford University