Teachers Leading the Frontlines (Tealeaf) - a Hybrid Effectiveness, Implement, and Context Trial

Summary

Purpose: The overall aim of this study is to evaluate the effectiveness, implementation, and contextual influences of a teacher-delivered transdiagnostic model of child mental health care (Tealeaf) for school-aged children in resource-limited primary schools in the Darjeeling Himalayas.

Participants: Within 90 rural, low-cost private primary schools across the Darjeeling and Kalimpong districts of the Indian Himalayas, all teachers meeting eligibility criteria will be invited to participate in training and the intervention. The number of teachers consented and enrolled into the study will be determined by the size of the school. The number of students nominated by a teacher is at their discretion (including an option to not nominate any student in a given year if they do not perceive any of the students to be appropriate for the intervention) However, based on the research team's pilot data and prior experience, teachers will be provided with the suggestion that they nominate two children to receive targeted intervention. For each child receiving intervention, a paired parent or guardian will be recruited and enrolled to the study.

Procedures (methods): Effectiveness will be evaluated through a botched stepped-wedge cluster randomized controlled trial with an embedded mixed methods evaluation of implementation and qualitative study of context (guided by the RE-AIM framework). Schools will begin in enhanced usual care (EUC) and cross over to the Tealeaf intervention as per a randomized schedule. In Batch 1, year 1 will include 60 schools in the control arm, year 2 will include 40 schools in the control arm and 20 in the intervention arm, year 3 will include 20 schools in the control arm and 40 in the intervention arm, and year 4 will include 60 schools in the intervention arm. Batch 2 will be operationalized in the third year of the study. In Batch 2, year 3 will include 30 schools in the control arm, year 4 will include 10 schools in the control arm and 20 schools in the intervention arm, and year 5 will include 30 schools in the intervention arm. 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.

Conditions

• Child Behavior Disorders

Interventions

BEHAVIORAL

Tealeaf

Tealeaf-Mansik Swasta (Tealeaf) Tealeaf is a task-shifting intervention in which teachers deliver transdiagnostic mental health care. Mental health challenges are understood through basic functional behavior assessments, providing a framework for the analysis of observable behaviors. Teachers deliver care primarily through the incorporation of basic therapeutic interactions into classroom instruction time, supplemented by one-on-one interactions with the child and family.

BEHAVIORAL

Enhanced Usual Care

Enhanced Usual Care (EUC) is a less intensive version of the Tealeaf intervention. The EUC service package has been designed to be the most intensive form of care that could be envisioned as viable in the study setting in the foreseeable future without a significant increase in resource investment

Sponsors & Collaborators

• Mariwala Health Initiative

  collaborator UNKNOWN

• Colorado School of Public Health

  collaborator OTHER

• University of North Bengal

  collaborator UNKNOWN

• University of Houston

  collaborator OTHER

• Broadleaf Health and Education Alliance

  collaborator OTHER

• Darjeeling Ladenla Road Prerna (DLRP)

  collaborator UNKNOWN

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Christina Cruz, MD, EdM · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-20

Primary Completion

2027-02-28

Completion

2027-02-28

Countries

• India

Study Locations