NCT05179759

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20,160

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress85%
Feb 2022Feb 2027

First Submitted

Initial submission to the registry

December 16, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

December 16, 2021

Last Update Submit

February 6, 2026

Conditions

Child Behavior Disorders

Keywords

childchild behaviorchild behavior disordersglobal healthIndiamental healthschoolsschool mental health servicesschool teachers/psychologystudents/psychologychild mental healthschool-based interventiontask shiftingteacher-delivered carestepped-wedge cluster randomized trialimplementation sciencetransdiagnostic interventionmixed-methods researchrural health

Outcome Measures

Primary Outcomes (1)

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

    The ASEBA TRF is a standardized tool to assess school adaptive function in children. Teachers rate the child on 7-point scales in four areas: how hard he/she is working, how appropriately he/she is behaving, how much he/she is learning, and how happy he/she is. Raw and T-scores on the Adaptive Functioning Scale are derived from the sum of the individual items. A higher score indicates better school adaptive function.

    8 months from baseline

Secondary Outcomes (4)

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

    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

  • TRF Adaptive Functioning

    8 months from baseline

Study Arms (10)

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

ACTIVE COMPARATOR

Clusters (schools) and associated participants are all assigned to the EUC condition in the 1st year of trial participation and transition to Tealeaf condition in subsequent years based on randomization assignment to 1 of 6 sequences in 1 of 2 batches.

Behavioral: Enhanced Usual Care

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

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. In Year 1, no schools are assigned to Tealeaf; schools transition to Tealeaf in subsequent years based on randomized assignment to 1 of 6 sequences and 1 of 2 batches.

Behavioral: Tealeaf

Tealeaf - Year 2: Clusters (schools) and associated participants assigned to EUC (control)

ACTIVE COMPARATOR

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. Based on randomization assignment, clusters (schools) and associated participants that are in the active comparator arm receive EUC condition in Year 2 of the trial.

Behavioral: Enhanced Usual Care

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

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. In Year 2, based on randomization assignment, clusters (schools) and associated participants that are in the experimental arm receive Tealeaf intervention.

Behavioral: Tealeaf

Tealeaf - Year 3: Clusters (schools) and associated participants assigned to EUC (control)

ACTIVE COMPARATOR

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. Based on randomization assignment, clusters (schools) and associated participants that are in the active comparator arm receive EUC condition in Year 3 of the trial.

Behavioral: Enhanced Usual Care

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

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. In Year 3, based on randomization assignment, clusters (schools) and associated participants that are in the experimental arm receive Tealeaf intervention.

Behavioral: Tealeaf

Tealeaf - Year 4: Clusters (schools) and associated participants assigned to EUC (control)

ACTIVE COMPARATOR

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. Based on randomization assignment, clusters (schools) and associated participants that are in the active comparator arm receive EUC condition in Year 4 of the trial.

Behavioral: Enhanced Usual Care

Tealeaf - Year 4: Clusters (schools) and associated participants assigned to Tealeaf (experimental)

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. In Year 4, based on randomization assignment, clusters (schools) and associated participants that are in the experimental arm receive Tealeaf intervention.

Behavioral: Tealeaf

Tealeaf - Year 5: Clusters (schools) and associated participants assigned to EUC (control)

ACTIVE COMPARATOR

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. In Year 5, all schools have transitioned to Tealeaf. No schools are in the comparator arm.

Behavioral: Enhanced Usual Care

Tealeaf - Year 5: Clusters (schools) and associated participants assigned to Tealeaf (experimental)

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. In Year 5, all clusters (schools) and associated participants are in the experimental arm and receive Tealeaf intervention.

Behavioral: Tealeaf

Interventions

TealeafBEHAVIORAL

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.

Tealeaf - Year 1: Clusters (schools) and associated participants assigned to Tealeaf (experimental)Tealeaf - Year 2: Clusters (schools) and associated participants assigned to Tealeaf (experimental)Tealeaf - Year 3: Clusters (schools) and associated participants assigned to Tealeaf (experimental)Tealeaf - Year 4: Clusters (schools) and associated participants assigned to Tealeaf (experimental)Tealeaf - Year 5: Clusters (schools) and associated participants assigned to Tealeaf (experimental)
Enhanced Usual CareBEHAVIORAL

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

Also known as: EUC
Tealeaf - Year 1: Clusters (schools) and associated participants assigned to EUC (control)Tealeaf - Year 2: Clusters (schools) and associated participants assigned to EUC (control)Tealeaf - Year 3: Clusters (schools) and associated participants assigned to EUC (control)Tealeaf - Year 4: Clusters (schools) and associated participants assigned to EUC (control)Tealeaf - Year 5: Clusters (schools) and associated participants assigned to EUC (control)

Eligibility Criteria

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

You may qualify if:

  • Clusters (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 $200/14,500 Indian rupee (INR) or less
  • Low-cost private primary schools in rural Darjeeling and Kalimpong districts
  • 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:

  • Clusters (schools):
  • Not located in urban areas of the Darjeeling and Kalimpong Districts defined as the statutory towns of Darjeeling, Kurseon, Mirik and the Kalimpong Municipality.
  • 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

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 cluster randomized stepped-wedge mental health intervention trial as trial participants and the intervention team will be aware of their status (open-label at the school and teacher level). 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 to 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. Outcome assessors will remain blinded throughout data collection. The study statistician will be unblinded for analysis purposes but will have no contact with study participants.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: The study will be conducted as a batched 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. Schools will be enrolled into one of two batches and randomization will occur at the school level with multiple sequences within each batch. 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, consistent with a hybrid effectiveness-implementation-context design. 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

December 16, 2021

First Posted

January 5, 2022

Study Start

February 20, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 10, 2026

Record last verified: 2026-01

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 including in de-identified form due to the potential for deductive disclosure, but may be available on reasonable request, subject to approval by Darjeeling Ladenla Road Prerna (DLRP) and DLRP governance.

Locations

IN(1)