School based stepped care TrEatment for adolescent depression in Pakistan- a Sequential Multiple Assignment Randomized Trial (SMART-STEP)

项目摘要 抑郁和焦虑（常见精神障碍，CMD）是健康负担的主要贡献者， 全世界的青少年，并与不良结局相关1，2。在巴基斯坦，报告的流行率 据估计，在校青少年的情绪问题在25%-35%之间3，4。学校被 被确定为弥合青少年心理健康治疗差距的可扩展平台5，6。但在 在巴基斯坦，没有正式的以学校为基础的促进青少年心理健康的方案。为了解决这个 未满足的需求，促进巴基斯坦人心理健康的总统计划，一项雄心勃勃的计划， 学校为基础的心理健康方案，以整个国家，发起了7，8。在总统的保护伞下， 通过我们的NIMH U19全球心理健康研究中心，SHINE（学校健康实施 网络：东地中海地区），我们1）改编和可行性测试了世界卫生组织学校心理健康 计划（SMHP）9纳入在线教师培训计划（加强学校心理健康计划[eSMHP]， www.learnwithshine.org）和2）支持开发和可行性测试的认知行为 治疗（CBT）的基础上，世界卫生组织明星（可持续技术，为青少年减少压力）自助聊天- 以解决在巴基斯坦低资源公立学校学习的青少年的CMD症状10。 eSMHP和STARS的试点实施已经确定，需要将这些干预措施纳入一个逐步的 护理包，并确定他们的最佳交付顺序，以解决异质性的介绍， 随着时间的推移，CMD的症状的进展，并确保具有成本效益的实施规模。因此 “智能步骤研究”的目的是调查eSMHP（低强度和最少资源）的有效性 强化治疗）（与TAU治疗）作为一线治疗，以改善 青少年抑郁症，以及STARS自助聊天机器人作为增强策略（二线治疗）， 解决对eSMHP和TAU无应答的早期迹象。通过使用顺序多重分配 随机试验（SMART）设计，比较这些干预策略的时间和剂量，我们将 在公立学校中回答“什么有效，对谁有效，在什么条件下有效，为什么有效”。 巴基斯坦我们假设接受eSMHP的青少年将表现出抑郁症状的改善 与TAU相比，在无应答的青少年中，通过STARS自助聊天增强eSMHP- bot（与继续进行初始干预相比）将从基线到9个月改善抑郁症症状。 我们将开始我们的工作，建立一个外部咨询委员会，咨询利益相关者， 青年人指导项目实施。下一步，SMART-STEP试验将调查（成本） 阶梯式护理包的有效性。这些研究目标与我的研究职业发展相一致 计划成为全球心理健康专家，优化对低血糖青少年CMD的干预措施， 该项目由一个经验丰富的共同调查员和顾问小组提供支助。

Project summary Depression and anxiety (common mental disorders, CMD’s) are the leading contributors to health burden in adolescents worldwide and are associated with adverse outcomes1,2. In Pakistan, the reported prevalence estimates of emotional problems in school going adolescents range between 25%- 35%3,4. Schools have been identified as a scalable platform to bridge the treatment gap for adolescent mental health5,6. However, in Pakistan, no formal system for school-based programs to promote youth mental health exists. To address this unmet need, a President’s Program to Promote Mental Health of Pakistanis, an ambitious plan to scale-up the school based mental health programs to the entire country, was initiated7,8. Under the umbrella of the President’s program and through our NIMH U19 Global Mental Health Research Hub, SHINE (School Health Implementation Network: Eastern Mediterranean Region), we 1) adapted and feasibility tested the WHO School Mental Health Program (SMHP)9 into an online teachers’ training program (Enhanced School Mental Health Program [eSMHP], www.learnwithshine.org) and 2) supported the development and feasibility testing of the Cognitive Behavioral Therapy (CBT) based, WHO STARS (Sustainable Technology for Adolescent to Reduce Stress) self-help chat- bot to address the symptoms of CMDs in adolescents studying in low resource public schools of Pakistan10. Pilot implementation of eSMHP and STARS has identified a need to integrate these interventions into a stepped care package and to determine their optimal delivery sequence to address heterogeneity in the presentation and progression of CMDs’ symptoms over time, and to ensure cost-effective implementation at-scale. Therefore, the aim of the ‘SMART-STEP study’ is to investigate the effectiveness of eSMHP (low intensity and least resource intensive treatment) (vs. Treatment as Usual-TAU) as a front-line treatment to improve the symptoms of depression in adolescents, and STARS self-help chat-bot as an augmentation tactic (second-line treatment) to address early signs of non-response to the eSMHP and TAU. By using Sequential Multiple Assignment Randomized Trial (SMART) design to compare the timing and dosage of these intervention strategies, we will answer ‘what works, for whom, under what conditions and why for adolescent depression’ in public schools of Pakistan. We hypothesize that adolescents who receive the eSMHP will show improved symptoms of depression compared to TAU, and among non-responding adolescents, augmenting eSMHP with the STARS self-help chat- bot (vs. continue with the initial intervention) will improve symptoms of depression from baseline to 9-months. We will begin our work by establishing an External Advisory Committee, consulting stakeholders and engaging young people to guide project implementation. Next, the SMART-STEP trial will investigate the (cost) effectiveness of stepped care package. These research aims are aligned with my research career development plans to become a global mental health expert in optimizing interventions for adolescents with CMDs in low- income communities and are supported by a highly experienced team of co-investigators and consultants.