Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia Nervosa

确认青少年神经性厌食症适应性治疗的功效/机制

• 批准号: 9884814
• 负责人: JAMES D LOCK
• 金额: $ 73.88万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-24 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9884814
• 关键词: Achievement; Address; Adolescent; Aftercare; Age; Ambulatory Care; Anorexia Nervosa; Behavior; Behavioral; Blinded; Body Weight; Body Weight Changes; California; Cessation of life; Child; Code; DSM-V; Data; Development; Disease remission; Eating; Evidence based treatment; Failure; Family; Family Study; Feeding behaviors; Gender; Height; Intervention; Mediating; Mediator of activation protein; Obsession; Outcome; Parents; Participant; Patients; Pilot Projects; Psychotherapy; Quality of life; Randomized; Recovery; Reporting; Risk; San Francisco; Self Efficacy; Signal Transduction; Site; Tail; Treatment outcome; Universities; Videotape; Weight; Weight Gain; adaptive intervention; alternative treatment; arm; base; clinically significant; comorbidity; design; evidence base; experience; family structure; feeding; follow-up; high risk; improved; improved outcome; outcome prediction; parental role; precision medicine; premature; primary outcome; response; skills; treatment arm; treatment effect; weight restoration

Confirming the efficacy/mechanism of an adaptive treatment for adolescent anorexia nervosa In adolescent anorexia nervosa (AN) 30-40% fully recover with Family Based Treatment (FBT) and remain so 3-4 years after treatment, but those who do not remit have a high risk of developing enduring AN with accompanying co-morbidities, much reduced quality of life, premature death, and for which there is no evidence-based treatment. Studies of FBT find that weight gain by session 4 predicts outcome in 85-90% of cases;  thus, one way to improve outcomes in line with precision medicine is to match treatments to patients depending on weight gain at session 4 by offering an alternative treatment to meet the specific needs of poor early responders (~44%). The aim of this study in response to RFA-MH-16-425 is to determine if an adaptive outpatient treatment compatible with FBT could significantly improve outcomes by addressing poor early response and add to our understanding of the mechanisms of treatment in FBT. We developed a 3- session (Intensive Parent Coaching-IPC) intervention to increase parental skills at re-feeding for this poor early responding group demonstrating the feasibility of using a randomized adaptive design employing IPC. Compared to expected weight restoration rates in poor early responders, 50% more participants achieved weight restoration than expected with an average mean weight of 96.7% by EOT (preliminary efficacy signal of Cohen's d= 0.82). Previous studies have shown that FBT specifically targets parental self-efficacy as the mechanism to promote weight restoration in their children with AN. Consistent with these studies, data from the current pilot RCT suggest that parents whose children do not gain 2.4 kg by session 4 report lower levels of self-efficacy related to re-feeding as early as session 2; however, after receiving FBT+IPC, parental self- efficacy scores in this group improve and become indistinguishable from those of parents of early responders. While these preliminary data are promising, a sufficiently powered and controlled RCT using an adaptive randomized design employing FBT+IPC as the adaptive intervention for poor early responders is needed to understand the role of parental efficacy and re-feeding behaviors in FBT before recommending an adaptive approach. To conduct an adequately powered study (0.87 (alpha=.05, two-tailed)), 150 adolescents (75 per site) will be randomized at 2 sites (Stanford University and the University of California, San Francisco) to either standard FBT or an adaptive treatment arm (FBT+IPC) where those who do not gain 2.4 kg by session 4 will receive additional treatment (FBT+IPC). Assessments (blinded to treatment condition) will be conducted at baseline, 3, 9 (EOT) and at 6 and 12-month follow-up. Our primary outcome will be achievement of weight remission (>94% expected mean percent BMI adjusted for age, height and gender).

确认青少年厌食症的自适应治疗的效率/机制 在青少年厌食症中（AN）30-40％通过家庭治疗（FBT）完全康复，并保持 因此，治疗后3 - 4年 参与合并症，生活质量大大降低，过早死亡，并且没有 循证治疗。 FBT的研究发现，在85-90％ 案件；因此，根据精确医学一致改善结果的一种方法是将治疗匹配 患者通过提供替代治疗来满足特定需求，这取决于第4节的体重增加 早期反应不佳（〜44％）。这项研究以响应RFA-MH-16-425的目的是确定是否是否 适应与FBT兼容的自适应门诊治疗可以通过解决贫困 早期反应并增加了我们对FBT治疗机制的理解。我们开发了3- 会议（密集的家长教练-IPC）干预措施，以提高父母的技能，以重新喂食这个贫穷的早期 响应组证明了使用IPC使用随机自适应设计的可行性。 与差的早期响应者的预期体重恢复率相比，获得的参与者增加了50％ 重量恢复比预期的，平均平均重量为96.7％，EOT（初步效率信号 科恩的d = 0.82）。先前的研究表明，FBT专门针对父母的自我效能感 用An促进孩子体重恢复的机制。与这些研究一致，来自 当前的飞行员RCT表明，孩子们没有收获2.4公斤的父母报告较低的水平 自我效能与早在第2次会议上有关；但是，在收到FBT+IPC后，父母自我 该小组的效率得分与早期响应者的父母的效率得分有所改善，并没有区别。 虽然承诺这些初步数据，但使用自适应的RCT足够动力和控制 采用FBT+IPC的随机设计是为较差的早期响应者的适应性干预措施 在推荐适应性之前，了解父母效率和重新喂养行为的作用 方法。进行足够动力的研究（0.87（alpha = .05，两尾）），150名青少年（每人75 站点）将在两个地点（斯坦福大学和加利福尼亚大学，旧金山）随机分配 标准FBT或自适应治疗部门（FBT+IPC），在第4次会议上不增长2.4公斤的人将 获得额外的治疗（FBT+IPC）。评估（对治疗状况蒙蔽）将在 基线，3、9（EOT）以及6个月和12个月的随访。我们的主要结果将是实现体重 缓解（> 94％的预期平均BMI百分比针对年龄，身高和性别调整）。