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临床试验/NCT04723277
NCT04723277已完成不适用

TeaLeaF: Teachers Leading the Frontlines

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
550
试验地点
2
主要终点
Mean Difference at Endline on the Strengths and Difficulties Questionnaire Total Difficulties Score

研究概览

简要总结

Twenty percent of all children struggle with mental health challenges, most of whom will remain unrecognized, unsupported, and unable to access quality care. A major barrier to closing this care gap is a lack of evidence-based delivery models that are contextualized to low-resource settings. The aim of this study is to evaluate the efficacy of teacher-delivered transdiagnostic mental healthcare for children in rural primary schools of India. Implementation process and context will also be examined.

This is a stepped-wedge cluster randomized controlled trials (SW-CRCT), with an embedded qualitative evaluation, that will be conducted in low-cost private primary schools in the rural Darjeeling Himalayas of India.

The primary outcome is children's mental health status measured by the Achenbach System of Empirically Based Assessment (ASEBA) Teacher Report Form and Strengths and Difficulties Questionnaire. Secondary outcomes include: 1) daily functioning measured by the Adaptive Behavior Assessment System (ABAS-3), 2) academic achievement measured by the Annual Status of Education Report (ASER) tool, and 3) school attendance. Outcome data will be collected at baseline and endline in each academic year. The primary analysis for each outcome is the mean score at endline for children receiving targeted intervention (Tealeaf: Mansik Swastha or Enhanced Usual Care) between trial arms. The primary hypothesis is that children receiving mental health struggles receiving the Tealeaf intervention will demonstrate improved mental health compared to children with mental health struggles receiving enhanced usual care.

The goal of the embedded qualitative study will be to explore the effect of cultural and social context on intervention implementation and efficacy, how and why changes may occur, and the culture, context, and community in which the study occurs. This qualitative research will be driven by the scientific standard of advanced qualitative methods (ethnography and participant observation).

This trial may offer a new approach to caring for children with mental health struggles that is potentially scalable in India as it empowers existing classroom teachers.

详细描述

Expanding access to children's mental health care is a critically important global health challenge. There is a substantial gap between who would benefit and those who receive care. Task-shifting has been one widely used approach to closing care gaps for other health challenges. However, alternative models for mental health care delivery targeting school-aged children, including task-shifting, are rare. Classroom teachers are uniquely positioned to deliver children's mental health care in a transdiagnostic task-shifting model.

TeaLeaf (TEAchers LEAding the Frontlines) is a research program based in the Darjeeling Himalayas with the goal to develop, test, and scale alternative and combined models of education and mental health care that leverage classroom teachers and synergies between the fields of education and child psychiatry to improve the lives of children with mental health struggles. A novel mental health program (Tealeaf-Mansik Swastha) has been developed with the aims to (i) improve access to evidence-based mental healthcare for children, (ii) improve children's mental health outcomes, and (iii) improve children's wellbeing, development, and academic functioning. Through this intervention teachers are empowered to incorporate simple, easy-to-use yet evidence-based mental health techniques in their everyday interaction with targeted students. This model shifts the paradigm of care from difficult to access episodic intervention to ongoing, therapeutic interactions occurring through their day.

Formative and pilot studies have demonstrated that teachers can deliver evidence-based mental health care with fidelity, and that this approach is broadly acceptable to stakeholders, and an early signal for effectiveness. In the present study, an evaluation of efficacy will be coupled with an embedded qualitative exploration of context and process. Evaluating efficacy, implementation processes of the program, and the context in which it occurs will generate valuable insights into how children's mental health care can best be delivered in resource-limited settings.

The primary objective of the study is to evaluate the efficacy of teacher-delivered transdiagnostic mental healthcare for school-aged children in resource-limited primary schools. The primary hypothesis is that children receiving the Tealeaf intervention will demonstrate improved mental health compared to children receiving Enhanced Usual Care (EUC). Secondary objectives are: 1) to evaluate the efficacy of the intervention with regards to children's daily functioning, academic achievement, and school attendance; 2) to explore the influence of culture and social context on intervention implementation and efficacy; 3) to evaluate implementation processes in order to understand how and why change may occur; and 4) to explore the locatedness of the site of intervention within the larger historical and socio-cultural context.

The study will be conducted as a SW-CRCT. Within the four-year TeaLeaF trial, a prospective 3-year sub-study has been defined. The original protocol was modified to include this sub-study [TeaLeaF(+); registered at Clinical Trials Registry - India (CTR-T)] due to the emergence of the COVID-19 pandemic. TeaLeaF(+) is a 3-year SW-CRCT with a similar structure and analysis plan to TeaLeaF but prospectively defined to begin in 2021. This sub-study will facilitate adjustment in the light of many changes in the broader context arising as a result of the impact of the COVID-19 pandemic and associated school closure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Complete double-blinding is not possible in this mental health intervention trial as trial participants and the intervention team will be aware of their status. However, to minimize bias and the risk of unmasking, the field team will be separated into intervention and data collection teams. The data collection team will be blinded to intervention allocation at the cluster-level and treatment status at the individual child level. Additionally, while over time it may be likely that children and caregivers are aware of the intervention delivered, they will not be explicitly informed of this allocation.

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Does not receive government aid (i.e., not subject to the rules and regulations of government or government-aided schools
  • At least 3 full-time classroom teachers on staff
  • Annual student fees $180/11,500 Indian rupee (INR) or less
  • Employed at a participating school
  • Have primary teaching responsibility in the primary grade level
  • Are 18 years or older
  • Enrolled in class I-IV
  • Enrolled in the classroom of a participating teacher

排除标准

  • Not located in the rural Darjeeling Himalayas (defined as the Mirik, Kurseong, and Darjeeling Sadar sub-divisions of the Darjeeling District and outside the statutory towns of Darjeeling, Kurseon, and MIrik)
  • Have been convicted and/or are under investigation for any child-related misconduct or maltreatment.
  • Do not have a parent or guardian who can provide informed consent

结局指标

主要结局

Mean Difference at Endline on the Strengths and Difficulties Questionnaire Total Difficulties Score

时间窗: 8 months from baseline

The Strengths and Difficulties Questionnaire Total is a standardized tool to measure for psychopathology in children and adolescents. A Total Difficulties scale score is derived by summing items from four problem subscales (emotional, conduct, hyperactivity/inattention, and peer relationship), while a fifth subscale (prosocial functioning) does not contribute to the overall severity score. Scores also include an internalizing score, externalizing score, and impact score. Individual problem scale items are scored from 0 to 2 (with higher scores indicating greater problem severity).

Mean Difference on the Achenbach System of Empirically Based Assessment (ASEBA) Teacher Report Form Total Problem Scale

时间窗: 8 months from baseline

ASEBA Teacher Report Form (TRF) Total Problems Scale is a standardized tool to assess health challenges in children. A raw score is derived by summing responses to 113 problem behavior questions with responses scored from 0 to 2. Higher scores indicate greater problem severity. This raw score is converted into T-scores, and children with Total Problem Scale t-scores lower than 60 are classified in the normal group, children with scores ranging from 60-63 are classified as borderline, and children with scores above 63 were classified as clinical.

次要结局

  • Mean Difference on Global Adaptive Composite Score of a locally-contextualized version of the Adaptive Behavior Assessment System 3rd Edition (ABAS-3).(8 months from baseline)
  • Mean Difference in Proportion of School Days Absent(8 months from baseline)
  • Mean Difference on Annual Status of Education Report (ASER) Composite Score(8 months from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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