Clinical trial NCT04723277: Efficacy of Teacher-delivered Child Mental Healthcare in Primary Schools of India
Official title: TeaLeaF: Teachers Leading the Frontlines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Disorders
Keywords: child
child behavior
child behavior disorders
global health
India
mental health
schools
school mental health services
school teachers/psychology
students/psychology
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of North Bengal, India
name: Darjeeling Ladenla Road Prerna
name: Broadleaf Health and Education Alliance
name: University of Colorado, Denver
name: American Academy of Child Adolescent Psychiatry.
First posted: 2021-01-25
Enrollment: 550
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Expanding access to children's mental health care is a critically important global health challenge. There is a substantial gap between who would benefit and those who receive care. Task-shifting has been one widely used approach to closing care gaps for other health challenges. However, alternative models for mental health care delivery targeting school-aged children, including task-shifting, are rare. Classroom teachers are uniquely positioned to deliver children's mental health care in a transdiagnostic task-shifting model.

TeaLeaf (TEAchers LEAding the Frontlines) is a research program based in the Darjeeling Himalayas with the goal to develop, test, and scale alternative and combined models of education and mental health care that leverage classroom teachers and synergies between the fields of education and child psychiatry to improve the lives of children with mental health struggles. A novel mental health program (Tealeaf-Mansik Swastha) has been developed with the aims to (i) improve access to evidence-based mental healthcare for children, (ii) improve children's mental health outcomes, and (iii) improve children's wellbeing, development, and academic functioning. Through this intervention teachers are empowered to incorporate simple, easy-to-use yet evidence-based mental health techniques in their everyday interaction with targeted students. This model shifts the paradigm of care from difficult to access episodic intervention to ongoing, therapeutic interactions occurring through their day.

Formative and pilot studies have demonstrated that teachers can deliver evidence-based mental health care with fidelity, and that this approach is broadly acceptable to stakeholders, and an early signal for effectiveness. In the present study, an evaluation of efficacy will be coupled with an embedded qualitative exploration of context and process. Evaluating efficacy, implementation processes of the program, and the context in which it occurs will generate valuable insights into how children's mental health care can best be delivered in resource-limited settings.

The primary objective of the study is to evaluate the efficacy of teacher-delivered transdiagnostic mental healthcare for school-aged children in resource-limited primary schools. The primary hypothesis is that children receiving the Tealeaf intervention will demonstrate improved mental health compared to children receiving Enhanced Usual Care (EUC). Secondary objectives are: 1) to evaluate the efficacy of the intervention with regards to children's daily functioning, academic achievement, and school attendance; 2) to explore the influence of culture and social context on intervention implementation and efficacy; 3) to evaluate implementation processes in order to understand how and why change may occur; and 4) to explore the locatedness of the site of intervention within the larger historical and socio-cultural context.

The study will be conducted as a SW-CRCT. Within the four-year TeaLeaF trial, a prospective 3-year sub-study has been defined. The original protocol was modified to include this sub-study \[TeaLeaF(+); registered at Clinical Trials Registry - India (CTR-T)\] due to the emergence of the COVID-19 pandemic. TeaLeaF(+) is a 3-year SW-CRCT with a similar structure and analysis plan to TeaLeaF but prospectively defined to begin in 2021. This sub-study will facilitate adjustment in the light of many changes in the broader context arising as a result of the impact of the COVID-19 pandemic and associated school closure.

The study setting is the rural Darjeeling Himalayas, a region of the state of West Bengal in India. The primary site of the intervention will be rural, low-cost community private schools. Low-cost private schools (rather than government schools) were chosen for this study because 1) this is the setting where the highest proportion of children in rural Darjeeling are educated, 2) implementation is more likely to occur with fidelity and quality in this setting, and 3) this setting represents a better environment for assessment of intervention efficacy.

The analysis for the primary outcome (mental health status) and secondary outcomes (daily functioning, academic achievement, and school attendance) will be conducted as a comparison between the intervention arm (Tealeaf) and control arm (EUC) within the context of the stepped wedge framework. The primary analysis will be based on child-level data for children receiving targeted intervention and will be a comparison of mean scores at endline.

A secondary analysis, utilizing a similar approach will be conducted to compare outcomes among a representative subsample of children not selected for targeted intervention between trial arms. An additional secondary analysis will be used to compare children selected to receive intervention with this representative subsample within each trial arm.

Additional analyses will be conducted for the following pre-specified subgroups: 1) gender/sex, 2) age (\<=; \>=8 years old) and 3) baseline mental health status. The investigators will also conduct a series of pre-specified exploratory analysis on sub-scales or domains for the main outcome measures. A cost-analysis will be performed to estimate the resources required to deliver Tealeaf and EUC.

All analysis will be conducted for both the 4-year TeaLeaF trial and the 3-year post-COVID sub-study \[Tealeaf(+)\]

The overarching goals 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. Grounded research techniques will be used to understand the participant's views and experiences in their context and to shed light on how 'process' aspects of the Tealeaf intervention are impacting communities, teachers, children, and families in a specific cultural context.

To that effect, the qualitative research will not be based on hypothesis testing. Rather it will be driven by the scientific standards of advanced qualitative methods (ethnography and participant observation) where iterative learning and reflection drive data collection and analysis. For this research, a subsample of schools will be selected through stratified purposive sampling. Within each school, in-depth longitudinal direct observation and interviews (and as needed focus groups) with school principals, teachers, parents, caregivers, and children enrolled in the study. This will be supplemented with field notes, process documentation, and data arising from project monitoring.

This trial is the first to evaluate the efficacy of teacher-delivered transdiagnostic mental healthcare for school-aged children in primary schools of a low-to-middle income county. The results of this study are expected to contribute to the limited evidence base for alternative models of children's mental health care in low-resource settings.

During the first year of the trial (2021), the study team will only use the first primary outcome measure, Mean Difference on the Achenbach System of Empirically Based Assessment (ASEBA) Teacher Report Form Total Problem Scale for the following reasons:

1. There is no control group to compare against
2. There is no EUC condition
3. During the 2021 year, we are most interested in identifying any confounding of primary outcome during COVID

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Mean Difference on the Achenbach System of Empirically Based Assessment (ASEBA) Teacher Report Form Total Problem Scale
timeFrame: 8 months from baseline
measure: Mean Difference at Endline on the Strengths and Difficulties Questionnaire Total Difficulties Score
timeFrame: 8 months from baseline
Secondary outcomes:
measure: Mean Difference on Global Adaptive Composite Score of a locally-contextualized version of the Adaptive Behavior Assessment System 3rd Edition (ABAS-3).
timeFrame: 8 months from baseline
measure: Mean Difference on Annual Status of Education Report (ASER) Composite Score
timeFrame: 8 months from baseline
measure: Mean Difference in Proportion of School Days Absent
timeFrame: 8 months from baseline
Other outcomes:
Locations:
city: Darjeeling
country: India
facility: DLR Prerna
state: West Bengal
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Christina Cruz, MD, EdM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tealeaf: Mansik Swastha [Internet]. @TeleafMansikSwastha. [cited 2020 Oct 8]. Available from: https://www.facebook.com/TealeafMansikSwastha
citation: 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/