NCT04723277

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

January 20, 2021

Last Update Submit

January 12, 2023

Conditions

Child Behavior Disorders

Keywords

childchild behaviorchild behavior disordersglobal healthIndiamental healthschoolsschool mental health servicesschool teachers/psychologystudents/psychology

Outcome Measures

Primary Outcomes (2)

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

    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.

    8 months from baseline

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

    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).

    8 months from baseline

Secondary Outcomes (3)

  • 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 on Annual Status of Education Report (ASER) Composite Score

    8 months from baseline

  • Mean Difference in Proportion of School Days Absent

    8 months from baseline

Study Arms (6)

Tealeaf - Year 1: Clusters (schools) and associated participants assigned to sequence 1

EXPERIMENTAL

Clusters (schools) and associated participants assigned to sequence 1 will be under the EUC condition in the 1st year of trial participation and under the Tealeaf condition in all subsequent years.

Behavioral: Enhanced Usual Care (EUC)

Enhanced Usual Care - Year 1: Clusters (schools) and associated participants assigned to sequence 2

ACTIVE COMPARATOR

Clusters (schools) and associated participants assigned to sequence 2 will be under the EUC condition in the 1st and 2nd year of trial participation and under the Tealeaf condition in all subsequent years.

Behavioral: Enhanced Usual Care (EUC)

Tealeaf - Year 2: Clusters (schools) and associated participants assigned to sequence 1

EXPERIMENTAL

Active intervention: 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.

Behavioral: Tealeaf-Mansik Swasta (Tealeaf)

Enhanced Usual Care - Year 2: Clusters (schools) and associated participants assigned to sequence 2

ACTIVE COMPARATOR

EUC (control arm)

Behavioral: Enhanced Usual Care (EUC)

Tealeaf - Year 3: Clusters (schools) and associated participants assigned to sequence 1

EXPERIMENTAL

Active intervention: 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.

Behavioral: Tealeaf-Mansik Swasta (Tealeaf)

Enhanced Usual Care - Year 3: Clusters (schools) and associated participants assigned to sequence 2

ACTIVE COMPARATOR

Active intervention: 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.

Behavioral: Tealeaf-Mansik Swasta (Tealeaf)

Interventions

Tealeaf-Mansik Swasta (Tealeaf)BEHAVIORAL

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.

Enhanced Usual Care - Year 3: Clusters (schools) and associated participants assigned to sequence 2Tealeaf - Year 2: Clusters (schools) and associated participants assigned to sequence 1Tealeaf - Year 3: Clusters (schools) and associated participants assigned to sequence 1
Enhanced Usual Care (EUC)BEHAVIORAL

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.

Enhanced Usual Care - Year 1: Clusters (schools) and associated participants assigned to sequence 2Enhanced Usual Care - Year 2: Clusters (schools) and associated participants assigned to sequence 2Tealeaf - Year 1: Clusters (schools) and associated participants assigned to sequence 1

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Schools:
  • 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
  • Teachers:
  • Employed at a participating school
  • Have primary teaching responsibility in the primary grade level
  • Are 18 years or older
  • Children
  • Enrolled in class I-IV
  • Enrolled in the classroom of a participating teacher

You may not qualify if:

  • Schools:
  • 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)
  • Teachers
  • Have been convicted and/or are under investigation for any child-related misconduct or maltreatment.
  • Children:
  • Do not have a parent or guardian who can provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DLR Prerna

Darjeeling, West Bengal, 73401, India

Location

Related Publications (3)

  • Tealeaf: Mansik Swastha [Internet]. @TeleafMansikSwastha. [cited 2020 Oct 8]. Available from: https://www.facebook.com/TealeafMansikSwastha

    BACKGROUND

  • Global Child Mental Health Collaborative: creating, testing, and implementing alternative systems of child and adolescent mental health care. [Internet]. [cited 2020 Oct 7]. Available from: https://globalchildmentalhealth.web.unc.edu/

    BACKGROUND

  • Giri P, Lamb MM, Fuentes VC, Thapa A, Bhattarai S, Dukpa C, Shrestha CC, Ekhteraei S, Vanderburg JL, Windsor B, Rauniyar AK, Hampanda K, Gaynes BN, Lama R, Matergia M, Cruz CM. Comparative child mental health and academic outcomes after primary school teachers deliver task-shifted mental health care in India. Discov Ment Health. 2025 Jun 18;5(1):90. doi: 10.1007/s44192-025-00217-2.

    PMID: 40531254DERIVED

MeSH Terms

Conditions

Child Behavior DisordersChild BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehaviorPersonal Satisfaction

Study Officials

  • Christina Cruz, MD, EdM

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: The study will be conducted as a stepped-wedge cluster randomized trial. Given the nature of the intervention, each school will be a cluster and each step will be an academic year. Randomization will occur at the school level. All schools will initially receive the control condition (EUC) and will be randomly and sequentially transitioned into the intervention arm. A qualitative exploration of context and process will be embedded within the framework of the randomized control trial. An embedded approach has been chosen to facilitate a high level of integration between the qualitative and quantitative components of the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 25, 2021

Study Start

January 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) generated during and/or analyzed during the study will not be publicly available due to the potential for deductive disclosure but may be available from Darjeeling Ladenla Road (DLR) Prerna on reasonable request.

Locations

IN(1)