Teachers Delivering Task-Shifted Mental Health Care to Adolescents in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Mean Number of Dropouts (Reach)
研究概览
简要总结
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted adolescent mental health care.
Participants: Principals of 60 rural, low-cost private secondary schools of the Darjeeling Himalayas will be invited to participate as a school and an individual. Teachers will be approached individually. Two students per teacher who meet inclusion criteria will be randomly chosen for enrollment.
Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods CRCT, clustered at schools, of Tealeaf-A's Reach, Adoption & Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness & Maintenance (Secondary Outcomes, clinically-based).
详细描述
The overarching goal of this proposal is to address the youth mental health crisis by increasing access to high quality, alternative, sustainable adolescent mental health care. The overall objective of this proposal is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted adolescent mental health care. In Darjeeling, India, the investigators will test Tealeaf (Teachers Leading the Frontlines - Mansik Swastha [Mental Health in Nepali]) as adapted for adolescents (Tealeaf-Adolescent; "Tealeaf-A"). Created in Darjeeling, Tealeaf centers on training and supervising elementary school teachers to deliver "education as mental health therapy" (Ed-MH) to children (age 5-12). Ed-MH is the investigators' novel, task-shifting, therapy modality that minimizes the time teachers need to deliver care by fitting it into their work.8 In Ed-MH, teachers use evidence-based therapeutic techniques adapted for use in their existing interactions with students in need (e.g., while teaching) and streamlined for care for any diagnosis ("transdiagnostic"). Tealeaf-A's adaptation (inclusive of Ed-MH) is supported by a Doris Duke Charitable Foundation (DDCF), Fund to Retain Clinical
Scientists (FRCS), Caregivers at Carolina COVID (Corona Virus Disease) award. The investigators' central hypotheses are that teachers can deliver Tealeaf-A (task-shifted mental health care fitted into their work) with fidelity, stakeholders (teachers, adolescents, parents, principals) will find Tealeaf-A acceptable & feasible, and adolescents in Tealeaf-A will show preliminary indicators of mental health symptom improvement versus a comparator. The investigators' rationale stems from two trials in Darjeeling where mental health symptoms of children in Tealeaf improved from clinical to neurotypical. The investigators propose a mixed methods explanatory sequential study, collecting quantitative (QUAN) then qualitative data (qual) to explain QUAN (QUAN-qual). The investigators' specific aims are:
- To determine if teachers can deliver Tealeaf-A with fidelity, with positive acceptability & feasibility for stakeholders, and leading to preliminary indicators of improved adolescent mental health outcomes (QUAN). Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, the investigators hypothesize that a pilot cluster randomized controlled trial (CRCT) of Tealeaf-A clustered at the school level (n=6 schools, 72 teachers, 144 students) will show that:
- Hypothesis 1a (H1a): Teachers can deliver Tealeaf-A with fidelity and positive feasibility & acceptability for stakeholders (Reach, Adoption, Implementation; Primary Outcomes), and
- Hypothesis 1b (H1b): Adolescents in Tealeaf-A will have preliminary indicators of improved student mental health symptoms versus a comparator (Effectiveness, Maintenance; Secondary Outcomes).
- To explore under what circumstances teachers can deliver Tealeaf-A with fidelity, with positive acceptability & feasibility for stakeholders, and that leads to preliminary indicators of improved adolescent mental health outcomes (qual; QUAN - qual). Guided by the Consolidated Framework for Implementation Research (CFIR), the investigators will explore the role of intervention and contextual factors in Aim 1 outcomes by completing key informant interviews with randomly selected stakeholders stratified by stakeholder group, school, and trial arm (n=42) 3 months Post intervention. Mixed methods data integration will occur in side-by-side QUAN-qual joint display tables. As this Aim is exploratory, it does not have a hypothesis to test. Based on previous results and review of the literature, though, the investigators discuss in Aim 2 in "Research Design & Methods" the anticipated findings.
Tealeaf-A Adaptation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will not be blinded; adolescents must assent, and parents consent, to receive mental health care and teachers will be aware they are delivering care. One research assistant (RA) will not be blinded to observe teachers' fidelity. Otherwise, personnel are blinded.
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LCP (Low-Cost Private) Secondary Schools
- •Enrolled families earning <$10 daily
- •Located in greater Darjeeling
- •Principal must also be eligible to participate
- •Principals:
- •>18 years old
- •Employed at enrolled school
- •Not suspected or convicted of child maltreatment
- •>18 years old
- •Employed at enrolled school
- •Not suspected or convicted of child maltreatment
- •Age 13 - 17 years
- •Student of enrolled teacher
- •Borderline or clinical Total Problem or subscale score of YSR (Youth Self-Report) and TRF (Teacher's Report Form)
- •Each student has a lead teacher (2/teacher), with their other teachers also involved
- •>18 years old
- •Guardian of enrolled student
- •Not suspected or convicted of child maltreatment
排除标准
- •Exclusion criteria will be set as each participant not meeting inclusion criteria as set for their group.
结局指标
主要结局
Mean Number of Dropouts (Reach)
时间窗: Month 9 of Academic Years 1 and 2
Dropout standards were set to indicate positive retention within arm per the investigators' previous trials and CRCTs clustered at schools and between arm per mental health therapy RCTs. Data will be analyzed at month 9 of Academic Years 1 and 2 (with month 0 being the start of training) with means compared to 10% dropout standard within arm.
Applied Mental Health Research Dissemination and Implementation Adoption Scale scores (Adoption)
时间窗: Month 0, Month 9 of Academic Years 1 and 2
Each student, guardian, teacher, and principal will fill out the Applied Mental Health Research (AMHR) Dissemination and Implementation (D\&I) Adoption scale. In other LMICs, these scales had adequate internal consistencies (0.61 to 0.95). They will be translated into Nepali, back-translated, and reviewed by a study collaborator. Each scale has 13-20 items. Each item is rated from 0 ("not at all") to 3 ("a lot") or "don't know/not applicable"; an average score of 2 or more per scale is a positive outcome. Data will be collected at Month 0 (post-training, pre-care) and/or starting at Month 9 (post) of Academic Years 1 and 2
Applied Mental Health Research Dissemination and Implementation Adoption Scale scores (Implementation)
时间窗: Month 9 of Academic Years 1 and 2
(3A) Fidelity: Observation checklists are from a 2018 fidelity study. The threshold was set within arm per the 2018 study and between arm per mental health care fidelity RCTs. Data will be collected at Month 9, when teachers are expected to have optimal fidelity across arms. (3B) Feasibility \& acceptability: AMHR specifics, data collection timing, and 3A \& 3B analyses are per "Adoption".
次要结局
- Change in Teacher's Report Form & Youth Self-Report (Effectiveness)(Month 0 up until Month 21 relative to Academic Years 1 and 2)
- Maintenance (Teacher's Report Form & Youth Self-Report)(Month 9, 12, 15, and 21 of Academic Year 2)