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

巴基斯坦青少年抑郁症的学校阶梯护理治疗——序贯多重分配随机试验 (SMART-STEP)

• 批准号: 10704136
• 负责人: Syed Usman Hamdani
• 金额: $ 48.39万
• 依托单位: SHIFA TAMEER-E-MILLAT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-14 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10704136
• 关键词: Address; Adolescent; Adopted; Advisory Committees; Anxiety; Behavioral; COVID-19 pandemic; Caring; Cognitive Therapy; Communities; Computers; Counseling; Country; Data; Decision Trees; Development; Development Plans; Early identification; Economics; Effectiveness; Effectiveness of Interventions; Emotional; Ensure; Guidelines; Health; Heterogeneity; Human; Income; Intervention; Knowledge; Life; Low income; Measures; Mediator; Mediterranean Region; Mental Depression; Mental Health; Mental Health Services; Mental disorders; Mental health promotion; National Institute of Mental Health; Pakistan; Parents; Patient Self-Report; Patients; Performance; Personal Satisfaction; Persons; Phase; Prevalence; Problem Solving; Psychosocial Assessment and Care; Questionnaires; Recommendation; Reporting; Research; Research Personnel; Resources; Schools; Sequential Multiple Assignment Randomized Trial; Site; Specialist; Specific qualifier value; Stress; Subgroup; Symptoms; System; Teacher Professional Development; Technology; Therapeutic; Thinking; Time; Training; Training Programs; Treatment outcome; Well in self; Work; World Health Organization; Youth; adverse outcome; aged; anxiety management; behavior test; career development; chatbot; child depression; clinical outcome measures; cognitive testing; common symptom; cost; cost effective; cost-effectiveness evaluation; depressive symptoms; design; dosage; effective intervention; effectiveness evaluation; effectiveness testing; evidence base; experience; feasibility testing; health literacy; improved; mental health policy; optimal treatments; programs; psychoeducation; psychoeducational; psychologic; psychological distress; recruit; reduce symptoms; relapse prevention; response; scale up; school health; self help; skills; stress management; stress reduction; success; symptom treatment; symptomatic improvement; teacher; treatment as usual; treatment optimization; trial design

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.

项目总结 抑郁和焦虑(常见的精神障碍，CMD‘s)是造成健康负担的主要因素 世界各地的青少年，并与不良后果有关1.在巴基斯坦，报告的流行率 对在校青少年情绪问题的估计在25%-35%3，4之间。 被确定为一个可扩展的平台，以弥合青少年心理健康的治疗差距5.然而，在 在巴基斯坦，不存在促进青少年心理健康的以学校为基础的方案的正式制度。要解决这个问题 未得到满足的需求，总统促进巴基斯坦人心理健康的计划，一项雄心勃勃的计划，扩大 以学校为基础的心理健康项目在全国范围内启动7，8。在总统的 计划并通过我们的NIMH U19全球心理健康研究中心，SIRE(学校健康实施 网络：地中海东部地区)，我们1)改编和可行性测试了世卫组织学校心理健康 将方案(SMHP)9纳入在线教师培训方案(增强的学校心理健康方案[eSMHP]， Www.learnwith shine.org)和2)支持认知行为量表的开发和可行性测试 以治疗(CBT)为基础，WHO STAR(青少年可持续技术减轻压力)自助聊天- BOT解决在巴基斯坦低资源公立学校学习的青少年的慢性精神障碍症状。 ESMHP和STAR的试点实施已经确定有必要将这些干预措施整合到一个步骤 护理包，并确定它们的最佳递送顺序，以解决演示和 随着时间的推移，CMD症状的进展，并确保具有成本效益的大规模实施。因此， 智能步进研究的目的是调查eSMHP(低强度和最少资源)的有效性 强化治疗)(与常规治疗相比--TAU)作为一种一线治疗，以改善 青少年中的抑郁症，并将自助聊天机器人作为增强策略(二线治疗) 解决对eSMHP和TAU没有反应的早期迹象。通过使用顺序多重赋值 随机试验(SMART)设计比较这些干预策略的时机和剂量，我们将 回答“什么对青少年抑郁症有效，对谁有效，在什么情况下有效，为什么对青少年抑郁症有效？” 巴基斯坦。我们假设接受eSMHP治疗的青少年会出现抑郁症状的改善。 与TAU相比，在没有反应的青少年中，使用STAR自助聊天来增强eSMHP- BOT(与继续最初的干预相比)将从基线到9个月改善抑郁症状。 我们将通过建立外部咨询委员会、咨询利益攸关方和参与 青年指导项目实施。下一步，精明步骤试验将调查(成本) 阶梯式护理套餐的有效性。这些研究目标与我的研究事业发展是一致的 计划成为全球心理健康专家，优化对患有低度慢性精神疾病的青少年的干预措施。 该项目由收入群体组成，并由一支经验丰富的合作调查员和顾问团队提供支持。