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Background <p>Mental health conditions affect a substantial proportion of school-aged children in low-resource settings, yet access to evidence-based care remains limited. In rural India, shortages of child mental health specialists, socioeconomic adversity, and structural barriers to care contribute to a large unmet need. Tealeaf is a transdiagnostic model of teacher-delivered mental health care that embeds evidence-based therapeutic techniques into routine classroom interactions. Developed in partnership with communities in the Darjeeling Himalayas, Tealeaf has demonstrated feasibility, acceptability, and effectiveness signals. This trial will evaluate its real-world effectiveness and examine implementation and contextual factors influencing care.</p> Methods <p>We will conduct a hybrid study of effectiveness, implementation, and context using a batched stepped-wedge cluster randomized controlled trial. Schools are organized into two batches, each consisting of multiple sequences. Within each batch, schools begin with enhanced usual care before crossing over to the Tealeaf intervention according to a randomized stepped-wedge schedule. In Tealeaf, teachers are trained to identify children with mental health needs and deliver individualized, transdiagnostic therapeutic strategies throughout the academic year. The primary effectiveness outcome is teacher-reported child mental health status; secondary outcomes include parent-reported symptoms, adaptive functioning, academic achievement, and attendance. Implementation outcomes will be assessed using the RE-AIM framework. A parallel qualitative study will generate contextual understanding through longitudinal ethnography, interviews, participant observation, and field notes. Qualitative analyses will examine how caregiving norms, institutional environments, and social conditions shape perceptions of mental health and influence implementation and variation in outcomes. Quantitative analyses will use mixed-effects models appropriate for batched stepped-wedge designs, with integration of qualitative and quantitative findings to assess contextual moderators of effectiveness and implementation.</p> Discussion <p>This study will generate rigorous evidence on the effectiveness of teacher-delivered, transdiagnostic mental health care in under-resourced school settings, while elucidating how implementation processes and context shape real-world impact.</p> Trial registration <p>ClinicalTrials.gov: NCT05179759 (protocol ID 21–2499), registered prospectively on January 5, 2022, <a href="https://clinicaltrials.gov/ct2/show/NCT05179759">https://clinicaltrials.gov/ct2/show/NCT05179759</a>. Clinical Trials Registry–India: CTRI/2022/02/040398, registered prospectively on February 18, 2022, <a href="https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=CTRI/2022/02/040398">https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=CTRI/2022/02/040398</a>.</p>

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Teacher-delivered transdiagnostic child mental healthcare in rural Indian primary schools (Tealeaf): study protocol for a batched stepped-wedge cluster randomized controlled trial with a hybrid effectiveness-implementation-context design

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月4日

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  • Michael Matergia,
  • Priscilla Giri,
  • Roshan P. Rai,
  • Molly Lamb,
  • Deepa Pandit,
  • Surekha Bhattarai,
  • Arpana Thapa,
  • Choden Dukpa,
  • Rinzi Lama,
  • Christina Cruz

摘要

Background

Mental health conditions affect a substantial proportion of school-aged children in low-resource settings, yet access to evidence-based care remains limited. In rural India, shortages of child mental health specialists, socioeconomic adversity, and structural barriers to care contribute to a large unmet need. Tealeaf is a transdiagnostic model of teacher-delivered mental health care that embeds evidence-based therapeutic techniques into routine classroom interactions. Developed in partnership with communities in the Darjeeling Himalayas, Tealeaf has demonstrated feasibility, acceptability, and effectiveness signals. This trial will evaluate its real-world effectiveness and examine implementation and contextual factors influencing care.

Methods

We will conduct a hybrid study of effectiveness, implementation, and context using a batched stepped-wedge cluster randomized controlled trial. Schools are organized into two batches, each consisting of multiple sequences. Within each batch, schools begin with enhanced usual care before crossing over to the Tealeaf intervention according to a randomized stepped-wedge schedule. In Tealeaf, teachers are trained to identify children with mental health needs and deliver individualized, transdiagnostic therapeutic strategies throughout the academic year. The primary effectiveness outcome is teacher-reported child mental health status; secondary outcomes include parent-reported symptoms, adaptive functioning, academic achievement, and attendance. Implementation outcomes will be assessed using the RE-AIM framework. A parallel qualitative study will generate contextual understanding through longitudinal ethnography, interviews, participant observation, and field notes. Qualitative analyses will examine how caregiving norms, institutional environments, and social conditions shape perceptions of mental health and influence implementation and variation in outcomes. Quantitative analyses will use mixed-effects models appropriate for batched stepped-wedge designs, with integration of qualitative and quantitative findings to assess contextual moderators of effectiveness and implementation.

Discussion

This study will generate rigorous evidence on the effectiveness of teacher-delivered, transdiagnostic mental health care in under-resourced school settings, while elucidating how implementation processes and context shape real-world impact.

Trial registration

ClinicalTrials.gov: NCT05179759 (protocol ID 21–2499), registered prospectively on January 5, 2022, https://clinicaltrials.gov/ct2/show/NCT05179759. Clinical Trials Registry–India: CTRI/2022/02/040398, registered prospectively on February 18, 2022, https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=CTRI/2022/02/040398.