Teachers Leading the Front Lines - Adolescent

NCT06248203 | Recruiting

• 1 other identifier: 23-1838
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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).

Conditions

Adolescent - Emotional Problem; Mental Health Issue; Psychosocial Functioning; Depression; Anxiety; Adolescent Behavior

Outcome Measures

Primary Outcomes (3)

• 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.

  Month 9 of Academic Years 1 and 2

• 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

  Month 0, Month 9 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".

  Month 9 of Academic Years 1 and 2

Secondary Outcomes (2)

• Change in Teacher's Report Form & Youth Self-Report (Effectiveness)

  Month 0 up until Month 21 relative to Academic Years 1 and 2

• Maintenance (Teacher's Report Form & Youth Self-Report)

  Month 9, 12, 15, and 21 of Academic Year 2

Study Arms (2)

Tealeaf - Adolescent

EXPERIMENTAL

The Tealeaf-A arm will have three randomized schools. Teachers in the Tealeaf-A arm will receive six days of training and then supervision every 2 weeks to deliver care.

Behavioral: Tealeaf-Mansik Swasta (Tealeaf) as adapted for Adolescents

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

The EUC arm will have three randomized schools and will be used as an ethical comparator for the Tealeaf-A arm. Teachers will receive two days of training, all materials, and no supervision.

Behavioral: Enhanced Usual Care (EUC)

Interventions

Enhanced Usual Care (EUC) BEHAVIORAL

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.

Enhanced Usual Care (EUC)

Tealeaf-Mansik Swasta (Tealeaf) as adapted for Adolescents BEHAVIORAL

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.

Also known as: Tealeaf-A

Tealeaf - Adolescent

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• 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

Study Sites (1)

Darjeeling Ladenla Road Prerna

Darjeeling, West Bengal, 734101, India

RECRUITING

Related Publications (16)

• van Ginneken N, Tharyan P, Lewin S, Rao GN, Meera SM, Pian J, Chandrashekar S, Patel V. Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-income countries. Cochrane Database Syst Rev. 2013 Nov 19;(11):CD009149. doi: 10.1002/14651858.CD009149.pub2.

  PMID: 24249541 BACKGROUND

• van Ginneken N, Chin WY, Lim YC, Ussif A, Singh R, Shahmalak U, Purgato M, Rojas-Garcia A, Uphoff E, McMullen S, Foss HS, Thapa Pachya A, Rashidian L, Borghesani A, Henschke N, Chong LY, Lewin S. Primary-level worker interventions for the care of people living with mental disorders and distress in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD009149. doi: 10.1002/14651858.CD009149.pub3.

  PMID: 34352116 BACKGROUND

• Patel V, Kieling C, Maulik PK, Divan G. Improving access to care for children with mental disorders: a global perspective. Arch Dis Child. 2013 May;98(5):323-7. doi: 10.1136/archdischild-2012-302079. Epub 2013 Mar 9.

  PMID: 23476001 BACKGROUND

• Shinde S, Weiss HA, Varghese B, Khandeparkar P, Pereira B, Sharma A, Gupta R, Ross DA, Patton G, Patel V. Promoting school climate and health outcomes with the SEHER multi-component secondary school intervention in Bihar, India: a cluster-randomised controlled trial. Lancet. 2018 Dec 8;392(10163):2465-2477. doi: 10.1016/S0140-6736(18)31615-5. Epub 2018 Nov 22.

  PMID: 30473365 BACKGROUND

• Burns BJ, Costello EJ, Angold A, Tweed D, Stangl D, Farmer EM, Erkanli A. Children's mental health service use across service sectors. Health Aff (Millwood). 1995 Fall;14(3):147-59. doi: 10.1377/hlthaff.14.3.147.

  PMID: 7498888 BACKGROUND

• Kola L, Kohrt BA, Hanlon C, Naslund JA, Sikander S, Balaji M, Benjet C, Cheung EYL, Eaton J, Gonsalves P, Hailemariam M, Luitel NP, Machado DB, Misganaw E, Omigbodun O, Roberts T, Salisbury TT, Shidhaye R, Sunkel C, Ugo V, van Rensburg AJ, Gureje O, Pathare S, Saxena S, Thornicroft G, Patel V. COVID-19 mental health impact and responses in low-income and middle-income countries: reimagining global mental health. Lancet Psychiatry. 2021 Jun;8(6):535-550. doi: 10.1016/S2215-0366(21)00025-0. Epub 2021 Feb 24.

  PMID: 33639109 BACKGROUND

• Liang L, Ren H, Cao R, Hu Y, Qin Z, Li C, Mei S. The Effect of COVID-19 on Youth Mental Health. Psychiatr Q. 2020 Sep;91(3):841-852. doi: 10.1007/s11126-020-09744-3.

  PMID: 32319041 BACKGROUND

• Frontiers Production Office. Erratum: The Potential Emergence of "Education as Mental Health Therapy" as a Feasible Form of Teacher-Delivered Child Mental Health Care in a Low and Middle Income Country: A Mixed Methods Pragmatic Pilot Study. Front Psychiatry. 2022 Jan 18;12:838044. doi: 10.3389/fpsyt.2021.838044. eCollection 2021.

  PMID: 35115975 BACKGROUND

• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

  PMID: 10474547 BACKGROUND

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

  PMID: 19664226 BACKGROUND

• Wong G, Greenhalgh T, Westhorp G, Buckingham J, Pawson R. RAMESES publication standards: realist syntheses. J Adv Nurs. 2013 May;69(5):1005-22. doi: 10.1111/jan.12095. Epub 2013 Jan 29.

  PMID: 23356726 BACKGROUND

• Pawson R, Greenhalgh T, Harvey G, Walshe K. Realist review--a new method of systematic review designed for complex policy interventions. J Health Serv Res Policy. 2005 Jul;10 Suppl 1:21-34. doi: 10.1258/1355819054308530.

  PMID: 16053581 BACKGROUND

• Cruz CM, Dukpa C, Vanderburg JL, Rauniyar AK, Giri P, Bhattarai S, Thapa A, Hampanda K, Gaynes BN, Lamb MM, Matergia M. Teacher, caregiver, and student acceptability of teachers delivering task-shifted mental health care to students in Darjeeling, India: a mixed methods pilot study. Discov Ment Health. 2022;2(1):21. doi: 10.1007/s44192-022-00024-z. Epub 2022 Oct 31.

  PMID: 36341156 BACKGROUND

• Pearson N, Naylor PJ, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020 Oct 31;6(1):167. doi: 10.1186/s40814-020-00634-w.

  PMID: 33292770 BACKGROUND

• Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.

  PMID: 20637084 BACKGROUND

• Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

  PMID: 20053272 BACKGROUND

MeSH Terms

Conditions

Adolescent Behavior; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Christina Cruz, MD; EdM

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Cruz, MD; EdM

CONTACT

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

Michael Matergia, MD

CONTACT

857-488-7209; michael.matergia@broadleafhea.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded; adolescents must assent, and parents consent, to receive mental health care and teachers will be aware they are delivering care. One research assistant (RA) will not be blinded to observe teachers' fidelity. Otherwise, personnel are blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted as a non-randomized cluster-controlled pre-post study. Given the nature of the intervention, each school will be a cluster. All schools will initially receive the control condition (EUC) and will be transitioned into the intervention arm (Tealeaf). A qualitative exploration of context and process will be embedded within the framework of the study. An embedded approach has been chosen to facilitate a high level of integration between the qualitative and quantitative components of the study.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available 12 months after the conclusion of the trial to allow researchers to analyze data and submit for peer review.
• Access Criteria: Data will be deposited in UNC Odum Institute's UNC Dataverse, a data repository service for the University of North Carolina at Chapel Hill (UNC) research community and its partners.

Locations

IN (1)