Teachers Leading the Front Lines - Adolescent — TeaLeaf-A  

Depression Clinical Trial

Official title: Teachers Delivering Task-Shifted Mental Health Care to Adolescents in India

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial Description

The overarching goal of this proposal is to address the youth mental health crisis by increasing access to high quality, alternative, sustainable adolescent mental health care. The overall objective of this proposal is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted adolescent mental health care. In Darjeeling, India, the investigators will test Tealeaf (Teachers Leading the Frontlines - Mansik Swastha [Mental Health in Nepali]) as adapted for adolescents (Tealeaf-Adolescent; "Tealeaf-A"). Created in Darjeeling, Tealeaf centers on training and supervising elementary school 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.8 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 (Corona Virus Disease) award. The investigators' central hypotheses are that teachers can deliver Tealeaf-A (task-shifted mental health care fitted into their work) with fidelity, stakeholders (teachers, adolescents, parents, principals) will find Tealeaf-A acceptable & feasible, and adolescents in Tealeaf-A will show preliminary indicators of mental health symptom improvement versus a comparator. The investigators' rationale stems from two trials in Darjeeling where mental health symptoms of children in Tealeaf improved from clinical to neurotypical. The investigators propose a mixed methods explanatory sequential study, collecting quantitative (QUAN) then qualitative data (qual) to explain QUAN (QUAN-qual). The investigators' specific aims are:

1. To determine if teachers can deliver Tealeaf-A with fidelity, with positive acceptability & feasibility for stakeholders, and leading to preliminary indicators of improved adolescent mental health outcomes (QUAN). Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, the investigators hypothesize that a pilot cluster randomized controlled trial (CRCT) of Tealeaf-A clustered at the school level (n=6 schools, 72 teachers, 144 students) will show that:

• Hypothesis 1a (H1a): Teachers can deliver Tealeaf-A with fidelity and positive feasibility & acceptability for stakeholders (Reach, Adoption, Implementation; Primary Outcomes), and

• Hypothesis 1b (H1b): Adolescents in Tealeaf-A will have preliminary indicators of improved student mental health symptoms versus a comparator (Effectiveness, Maintenance; Secondary Outcomes).

2. To explore under what circumstances teachers can deliver Tealeaf-A with fidelity, with positive acceptability & feasibility for stakeholders, and that leads to preliminary indicators of improved adolescent mental health outcomes (qual; QUAN - qual). Guided by the Consolidated Framework for Implementation Research (CFIR), the investigators will explore the role of intervention and contextual factors in Aim 1 outcomes by completing key informant interviews with randomly selected stakeholders stratified by stakeholder group, school, and trial arm (n=42) 3 months Post intervention. Mixed methods data integration will occur in side-by-side QUAN-qual joint display tables. As this Aim is exploratory, it does not have a hypothesis to test. Based on previous results and review of the literature, though, the investigators discuss in Aim 2 in "Research Design & Methods" the anticipated findings.

Tealeaf-A Adaptation:

Implemented over a school year, Tealeaf has six components. (1) Teachers first complete six days of training on components 2-6, delivered by the investigators' local collaborator's team (DLRP) of psychiatric social workers with 8 years of experience with Tealeaf. (2) Teachers then nominate students for care based on their judgment, grounded in their everyday interactions with students. This method was chosen based on accuracy (as in "Evidence") and to avoid 1:1 screenings that may identify to others which students need mental health support. (3) They next analyze these students' symptoms with basic functional behavioral assessments. (4) Informed by behavior analyses, they then develop an individualized response using the 4Cs plan (Cause, Change, Connect, and Cultivate). Behavior plans (4Cs) are the chosen care framework (not manualized care) as they align with how teachers individualize teaching to students' needs. The goal of the 4Cs is to improve mental health through and in addition to learning, whereas typical behavior plans solely target improved learning. Teachers have improved learning but not mental health symptoms when individualizing pedagogy using behavior plans; individualization alone was not sufficient. In the 4Cs, teachers pick transdiagnostic therapeutic techniques to deliver from an Ed-MH menu of evidence-based options. For children, Tealeaf's current target, Ed-MH adapts Cognitive Behavior Play Therapy (CBPT) measures for classroom delivery. Based in Cognitive Behavior Therapy (CBT), CBPT is accessible to children <10 years old using both talk and play therapy. Play therapy for children and CBT for youth >10 years old have repeatedly improved symptoms. Ed-MH techniques include managing behaviors in class, 1:1 sessions, and adjusting knowledge transfer processes. (5) Working with caregivers as they see fit, as professional clinicians do, teachers encourage 4Cs use at home. (6) Teachers deliver Ed-MH over a school year, with supervision every two weeks and guided by iterative 4Cs as students' needs evolve.

The investigators adapted Tealeaf to address adolescent needs (Tealeaf-A) in 2022 with support from a DDCF FRCS award. Adaptations to better target adolescents include: (1) changing Ed-MH techniques from CBPT to CBT (i.e., abstract cognitive concepts rather than play approaches); (2) modifying Tealeaf's structure as students have different teachers for different subjects (where 1 teacher will be the lead and coordinate with other teachers); (3) newly compensating teachers given this additional coordination and for caring for more students since each teacher sees more students as subject teachers; and (4) enhancing confidentiality. Confidentiality adaptations included: (4a) focusing Ed-MH techniques on homework changes rather than classwork to avoid in-class additional attention; (4b) limiting what is shared with caregivers to safety information; and (4c) having discrete spaces in schools to meet 1:1.

Tealeaf and Ed-MH's mechanism of action for improving mental health symptoms is through teachers guiding adolescents to consistently practice coping skills and emotion regulation for long periods of time (a school day) and in real time (in the moments of concern). Like counselors, Tealeaf teachers help students gain insight and acquire coping skills. Teachers take the therapy activities farther, though, by overseeing adolescents practicing coping skills, reinforcing positive behavior, and supporting them in moments of struggle, all in real time. It is ideally how teachers would work with students as guided by a therapist, but here themselves determine how to therapeutically respond to a student's mental health needs since therapists are rare. Moreover, as a role model, teachers already play a key role in the social, emotional, and academic development of students and interact with them individually in moments of concern. Ed-MH allows teachers to deliver therapy in shared moments, in real-time. Professional and lay counselors, instead, can only reflect from afar on moments the student is willing to share in the office.

A second mechanism of action is through teachers delivering care that can target education symptoms of mental health as seen in India. In the Ed-MH example in "Background", the student had poor schoolwork due to anxiety. His teacher can target his poor schoolwork (the education symptom of his mental health) and anxiety by improving schoolwork quality (an education intervention) through building his capacity to complete assignments gradually, i.e., exposure therapy (an evidence-based therapy technique). After care, both symptoms improved.

Intervention evidence: Results from 2018 and 2019 pilot Tealeaf trials show that mental health care delivery for children can be shifted to teachers. (1) Teachers (n=19) nominated students (n=36) with moderate accuracy, 72% sensitivity and 62% specificity, aligned with identification by lay counselors in LMICs (Low- or Middle-Income Countries) and teachers in HICs (High-Income Countries). (2) Teachers (n=19) delivered care with fidelity, on average at or above 60% fidelity to protocol, similar to mental health professionals' fidelity to new therapies. (3) Teachers (n=19) found it feasible to deliver therapy when integrated into their workflow (Ed-MH), citing choice of therapeutic techniques and the ability to incorporate them into teaching.(4) Teachers, families, and students found it acceptable for teachers to deliver mental health care.Teachers cited flexible care delivery, families cited impact, and students cited being treated well. (5) Children's mental health symptoms improved after receiving Ed-MH from their teachers, an early signal of impact. Symptoms improved on average from clinical to neurotypical, i.e., from the 77th to the 60th percentile baseline to end line on a gold standard measure in 2018 (n=36) and from the 84th to the 68th percentile in 2019 (n=26). While supported children in 2019 had neurotypical symptom levels at end line, children receiving enhanced usual care (n=188) remained at clinical levels (81st percentile). These findings support teachers' delivery of task-shifted, indicated child mental health care that is transdiagnostic and integrated into their work. This structure is similar to teacher-delivered adolescent promotion and prevention that has improved mental health outcomes. Thus, a next logical step is to test teachers' delivery of indicated adolescent care structured similarly to (1) adolescent prevention & promotion and (2) indicated children's care.

The investigators' rationale for pilot testing Tealeaf-A is based on Tealeaf's promising results as there is an urgent need to identify and deliver evidence-based adolescent mental health interventions to tackle the adolescent mental health care gap that worsened into a crisis during the COVID pandemic. Adapting Tealeaf to adolescents and its testing would occur ideally after completing the investigators' Type 1 hybrid effectiveness-implementation trial of Tealeaf for children (ongoing, in year 2 of 4). Of note, Tealeaf skipped over efficacy (lab-like setting) to effectiveness testing (real world), as literature supports skipping efficacy testing of task-shifted mental health care. Task-shifting improves mental health outcomes in lab-like settings and is now recommended to be tested in specific forms (e.g., teacher-delivery) for specific contexts to study its effects in real world practice. The high risk of poor care access, such as disability, to a large population of adolescents justifies Tealeaf's accelerated testing based on its promise. Also, recent implementation science literature supports parallel trials of the same intervention to accelerate research translation into practice since evidence takes 17 years on average to reach clinical practice. Supported by literature, creating Tealeaf-A given promising results was then supported by a DDCF FRCS award, further substantiating the accelerated pursuit of Tealeaf-A. Also, Tealeaf-A care delivery would ideally include teachers and peers. Due to resource limitations and prioritizing indicated over complementary care, a teacher-led Tealeaf-A adaptation was prioritized. A grant is pending to develop a peer component. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06248203
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Contact: Christina Cruz, MD; EdM
• Phone: 347-721-1458
• Email: christina_cruz@med.unc.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 29, 2024
• Completion date: February 1, 2026