Efficacy of Teacher-delivered Child Mental Healthcare in Primary Schools of India

NCT04723277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2023-01-17

No results posted yet for this study

Summary

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.

Conditions

  • Child Behavior Disorders

Interventions

BEHAVIORAL

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. Teachers receive ongoing supervision and support from the intervention team including monthly site visits supplemented by monthly and as-needed telephone discussions.

BEHAVIORAL

Enhanced Usual Care (EUC)

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

  • University of North Bengal, India

    collaborator UNKNOWN
  • Darjeeling Ladenla Road Prerna

    collaborator UNKNOWN
  • Broadleaf Health and Education Alliance

    collaborator OTHER
  • University of Colorado, Denver

    collaborator OTHER
  • American Academy of Child Adolescent Psychiatry.

    collaborator OTHER
  • 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
2019-01-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04723277 on ClinicalTrials.gov