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
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
More Related Trials
-
Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
NCT02350257 ·Status: COMPLETED ·Phase: NA
-
Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
NCT01667822 ·Status: COMPLETED ·Phase: PHASE3
-
Mental Health Prevention Among Preschool Children Using a Culturally Adapted Version of ICPS
NCT03383172 ·Status: UNKNOWN ·Phase: NA
-
Improving Student Mental Health: Adaptive School-based Implementation of CBT
NCT03541317 ·Status: COMPLETED ·Phase: NA
-
Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya
NCT06489314 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Implementation and Evaluation of the ChildTaks+ Intervention in the Czech Republic
NCT05554458 ·Status: COMPLETED ·Phase: NA
-
Effectiveness Study of a Treatment to Improve the Mental Health of Children and Adolescents
NCT03075475 ·Status: TERMINATED ·Phase: NA
-
School-based IPT-G for Adolescents With Depression in Nepal: a Pilot Realist C-RCT
NCT06017700 ·Status: UNKNOWN ·Phase: NA
-
Primary Care Online Emotion-regulation Treatment
NCT05032547 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of School-Based Cognitive Behavioral Therapy in Preventing Depression in Young Adolescents
NCT00360451 ·Status: COMPLETED ·Phase: PHASE3
-
Telepsychotherapy for the Treatment of Adolescents With Trichotillomania
NCT03725163 ·Status: UNKNOWN ·Phase: NA
-
Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care
NCT01147614 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents with Depression
NCT04977856 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care
NCT01565213 ·Status: COMPLETED ·Phase: PHASE3
-
Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings
NCT04928001 ·Status: COMPLETED ·Phase: NA
-
A Transdiagnostic Course for Common Mental Health Problems in Primary Care
NCT04522713 ·Status: COMPLETED ·Phase: NA
-
Development of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention for Rural High School Students
NCT07240792 ·Status: RECRUITING ·Phase: NA
-
Stepped Care Versus Group Cognitive Behaviour Therapy for Paediatric Anxiety in Primary Care
NCT06212362 ·Status: RECRUITING ·Phase: NA
-
Mental Health Prevention Among Preschool Children Effectiveness Study
NCT03683056 ·Status: UNKNOWN ·Phase: NA
-
Using Telehealth to Deliver Mental Health Services in Primary Care Settings for Children in Underserved Areas
NCT02396576 ·Status: COMPLETED ·Phase: NA
-
Task Sharing for the Care of Severe Mental Disorders in a Low-income Country
NCT02308956 ·Status: COMPLETED ·Phase: PHASE3
-
Pilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents
NCT05936255 ·Status: TERMINATED ·Phase: NA
-
Effectiveness and Cost-effectiveness of Telephone-delivered Psychotherapy for Depression in Primary Care
NCT02667366 ·Status: UNKNOWN ·Phase: NA
-
Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression
NCT02363205 ·Status: COMPLETED ·Phase: NA
-
Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System
NCT03105973 ·Status: COMPLETED ·Phase: NA