About this trial
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted adolescent mental health care.
Participants: Principals of 60 rural, low-cost private secondary schools of the Darjeeling Himalayas will be invited to participate as a school and an individual. Teachers will be approached individually. Two students per teacher who meet inclusion criteria will be randomly chosen for enrollment.
Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods CRCT, clustered at schools, of Tealeaf-A's Reach, Adoption \& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \& Maintenance (Secondary Outcomes, clinically-based).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
LCP (Low-Cost Private) Secondary Schools
Enrolled families earning <$10 daily
Located in greater Darjeeling
Principal must also be eligible to participate
Disqualifiers
Exclusion criteria will be set as each participant not meeting inclusion criteria as set for their group.
Trial design
Crossover
Treatments tested in this trial
Tealeaf-Mansik Swasta (Tealeaf) as adapted for Adolescents
BehavioralThe investigators will test Tealeaf (Teachers Leading the Frontlines - Mansik Swastha \[Mental Health in Nepali\]) as adapted for adolescents. Tealeaf is a task-shifting intervention in which teachers deliver transdiagnostic mental health care. Created in Darjeeling, Tealeaf centers on training and supervising teachers to deliver "education as mental health therapy" (Ed-MH) to children (age 5-12). Ed-MH is the investigators' novel, task-shifting, therapy modality that minimizes the time teachers need to deliver care by fitting it into their work. In Ed-MH, teachers use evidence-based therapeutic techniques adapted for use in their existing interactions with students in need (e.g., while teaching) and streamlined for care for any diagnosis ("transdiagnostic"). Tealeaf-A's adaptation (inclusive of Ed-MH) is supported by a Doris Duke Charitable Foundation (DDCF), Fund to Retain Clinical Scientists (FRCS), Caregivers at Carolina COVID award.
Enhanced Usual Care (EUC)
BehavioralEnhanced 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.
Treatment groups
Trial outcomes
Primary outcomes
Mean Number of Dropouts (Reach)
Dropout standards were set to indicate positive retention within arm per the investigators' previous trials and CRCTs clustered at schools and between arm per mental health therapy RCTs. Data will be analyzed at month 9 of Academic Years 1 and 2 (with month 0 being the start of training) with means compared to 10% dropout standard within arm.
Applied Mental Health Research Dissemination and Implementation Adoption Scale scores (Adoption)
Each student, guardian, teacher, and principal will fill out the Applied Mental Health Research (AMHR) Dissemination and Implementation (D\&I) Adoption scale. In other LMICs, these scales had adequate internal consistencies (0.61 to 0.95). They will be translated into Nepali, back-translated, and reviewed by a study collaborator. Each scale has 13-20 items. Each item is rated from 0 ("not at all") to 3 ("a lot") or "don't know/not applicable"; an average score of 2 or more per scale is a positive outcome. Data will be collected at Month 0 (post-training, pre-care) and/or starting at Month 9 (post) of Academic Years 1 and 2
Applied Mental Health Research Dissemination and Implementation Adoption Scale scores (Implementation)
(3A) Fidelity: Observation checklists are from a 2018 fidelity study. The threshold was set within arm per the 2018 study and between arm per mental health care fidelity RCTs. Data will be collected at Month 9, when teachers are expected to have optimal fidelity across arms. (3B) Feasibility \& acceptability: AMHR specifics, data collection timing, and 3A \& 3B analyses are per "Adoption".
Secondary outcomes
Change in Teacher's Report Form & Youth Self-Report (Effectiveness)
To estimate effect sizes for all TRF (Teacher's Report Form) and YSR (Youth Self-Report) scores Pre-Post within arm, and between arms, the investigators will calculate Cohen's d. The TRF measures problem behaviors that children may present in school. This is done through questions about the child's academic performance, questions comparing the child to their peers, and a 112 item scale with answer options from 0 ("not true") to 2 ("very true or often true"). The YSR is a 112 item scale that measures "problem behaviors" with answer options from 0 ("not true") to 3 ("very true or often true"). The investigators will compare scores at these same time points using multilevel, multivariable generalized linear regression models (up to 2 levels \[teacher, school\]) to (1) account for nested data collection (e.g., 1 teacher rating multiple students) and (2) control for sex/gender, other relevant demographics (e.g., income), and potential confounders (e.g., outpatient care).
Maintenance (Teacher's Report Form & Youth Self-Report)
For Maintenance, the investigators will compare TRF and YSR scores at Month 9 minus scores at Months 12, 15, and 21 of Academic Year 2 using multilevel, multivariable generalized linear regression models (see "Effectiveness").
Sponsors and contacts
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University of North Carolina, Chapel Hill
Lead sponsor
University of North Bengal, India
Collaborator
Darjeeling Ladenla Road Prerna
Collaborator
Broadleaf Health and Education Alliance
Collaborator
University of Colorado, Denver
Collaborator
Doris Duke Charitable Foundation
Collaborator