Adolescent BehaviorAdolescent - Emotional ProblemMental Health IssuePsychosocial FunctioningDepressionAnxiety
Investigational drug(s) / intervention(s)
Tealeaf-Mansik Swasta (Tealeaf) as adapted for AdolescentsEnhanced Usual Care (EUC)
Tealeaf-Mansik Swasta (Tealeaf) as adapted for Adolescents: The 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): 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.
Study summary
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
Sex
ALL
Min age
13 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Schools:
* LCP (Low-Cost Private) Secondary Schools
* Enrolled families earning \<$10 daily
* Located in greater Darjeeling
* Principal must also be eligible to participate
Principals:
* \>18 years old
* Employed at enrolled school
* Not suspected or convicted of child maltreatment
Teachers:
* \>18 years old
* Employed at enrolled school
* Not suspected or convicted of child maltreatment
Students:
* Age 13 - 17 years
* Student of enrolled teacher
* Borderline or clinical Total Problem or subscale score of YSR (Youth Self-Report) and TRF (Teacher's Report Form)
* Each student has a lead teacher (2/teacher), with their other teachers also involved
Guardians
* \>18 years old
* Guardian of enrolled student
* Not suspected or convicted of child maltreatment
Exclusion Criteria:
* Exclusion criteria will be set as each participant not meeting inclusion criteria as set for their group.
Primary outcome measure(s)
Mean Number of Dropouts (Reach) — Month 9 of Academic Years 1 and 2 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) — Month 0, Month 9 of Academic Years 1 and 2 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) — Month 9 of Academic Years 1 and 2 (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".
Trial sites (1)
Facility
City
Region
Status
Darjeeling Ladenla Road Prerna
Darjeeling
West Bengal
Recruiting
More University of North Carolina, Chapel Hill trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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