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Recruiting NCT06248203

NCT06248203 Teachers Leading the Front Lines - Adolescent

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Clinical Trial Summary
NCT ID NCT06248203
Status Recruiting
Phase
Sponsor University of North Carolina, Chapel Hill
Condition Adolescent Behavior
Study Type INTERVENTIONAL
Enrollment 216 participants
Start Date 2024-02-29
Primary Completion 2027-02-01

Eligibility & Interventions

Sex All sexes
Min Age 13 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Tealeaf-Mansik Swasta (Tealeaf) as adapted for AdolescentsEnhanced Usual Care (EUC)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 216 participants in total. It began in 2024-02-29 with a primary completion date of 2027-02-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

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.

Contact & Investigator

Central Contact

Christina Cruz, MD; EdM

✉ christina_cruz@med.unc.edu

📞 347-721-1458

Principal Investigator

Christina Cruz, MD; EdM

PRINCIPAL INVESTIGATOR

University of North Carolina, Chapel Hill

Frequently Asked Questions

Who can join the NCT06248203 clinical trial?

This trial is open to participants of all sexes, aged 13 Years or older, studying Adolescent Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06248203 currently recruiting?

Yes, NCT06248203 is actively recruiting participants. Contact the research team at christina_cruz@med.unc.edu for enrollment information.

Where is the NCT06248203 trial being conducted?

This trial is being conducted at Darjeeling, India.

Who is sponsoring the NCT06248203 clinical trial?

NCT06248203 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Christina Cruz, MD; EdM at University of North Carolina, Chapel Hill. The trial plans to enroll 216 participants.

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