RecruitingNot Applicable

Teachers Leading the Front Lines - Adolescent

India216 participantsStarted 2024-02-29

Plain-language 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).

Who can participate

Age range

13 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Number of Dropouts (Reach)

Timeframe: Month 9 of Academic Years 1 and 2

Applied Mental Health Research Dissemination and Implementation Adoption Scale scores (Adoption)

Timeframe: Month 0, Month 9 of Academic Years 1 and 2

Applied Mental Health Research Dissemination and Implementation Adoption Scale scores (Implementation)

Timeframe: Month 9 of Academic Years 1 and 2

Trial details

NCT IDNCT06248203

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-01

Contact for this trial

Christina Cruz, MD; EdM

347-721-1458 christina_cruz@med.unc.edu

View on ClinicalTrials.gov More Adolescent Behavior trials

Plain-language summary

Who can participate

Age range

13 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Number of Dropouts (Reach)

Timeframe: Month 9 of Academic Years 1 and 2

Applied Mental Health Research Dissemination and Implementation Adoption Scale scores (Adoption)

Timeframe: Month 0, Month 9 of Academic Years 1 and 2

Applied Mental Health Research Dissemination and Implementation Adoption Scale scores (Implementation)

Timeframe: Month 9 of Academic Years 1 and 2