Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05179759 |
| Other study ID # |
21-2499 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 2026 |
Study information
| Verified date |
January 2024 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: The primary aim of this research is to evaluate the effectiveness of
teacher-delivered transdiagnostic mental healthcare for school-aged children in
resource-limited primary schools.
Participants: Within 60 rural, low-cost private primary schools of the Darjeeling Himalayas,
all teachers meeting eligibility criteria will be invited to participate in training and the
intervention. The number of teachers consented and enrolled into the study will be determined
by the size of the school. The number of students nominated by a teacher is at their
discretion (including an option to not nominate any student in a given year if they do not
perceive any of the student's to be appropriate for the intervention) However, based on the
research team's pilot data and prior experience, teachers will be provided with the
suggestion that they nominate two children to receive targeted intervention. For each child
receiving intervention, a paired parent or guardian will be recruited and enrolled to the
study.
Procedures (methods): Effectiveness will be evaluated through a stepped-wedge cluster
randomized controlled trial (SW-CRCT) with an embedded mixed methods evaluation of
implementation and qualitative study of context (guided by the RE-AIM framework). Year 1 will
include 60 schools in the control arm, year 2 will include 40 schools in the control arm and
20 in the intervention arm, year 3 will include 20 schools in the control arm and 40 in the
intervention arm, and year 4 will include 60 schools in the intervention arm.
Description:
Expanding access to children's mental health care is a critically important global health
challenge. Twenty percent of all children suffer from significant mental health concerns,
most of whom will remain unrecognized, unsupported and affected throughout their lives. In
India and low and middle income countries (LMICs), the burden of children's mental illness is
particularly heavy due to large populations with high proportions of children and
adolescents, high rates of adverse childhood events and poverty, limited resources to care
for children and under-recognition of their mental health struggles. Despite prevalence rates
in India estimated to be on the high end of the global burden, less than 1% of Indian
children and adolescents with mental health struggles are receiving treatment. The need to
address this care gap is further intensified by the adverse impact of the ongoing Covid-19
pandemic. Task-shifting of mental health care tasks to non-specialist providers and lay
individuals in LMICs has been shown repeatedly to increase access to care and improve mental
health outcomes; it represents a promising approach to delivery of child mental healthcare.
However, alternative models for children's mental healthcare, including task-shifting, are
rare and reflect several significant barriers. Provision of such care occurring in the
context of children's evolving cognitive and emotion-recognition abilities requires knowledge
of and experience in child development. Furthermore, given limited funding and few
professional providers for children's mental health, sustainable care models likely need to
leverage existing systems and require few or no additional human resources. With relevant
professional experience and consistent access to children within existing education systems,
teachers are uniquely positioned to address these barriers and deliver care to children.
School-based mental health interventions are commonly conceptualized using the Multi-Tiered
Systems of Support (MTSS) framework which defines three levels of support corresponding with
Tier 1(promotion), Tier 2 (prevention), and Tier 3 (intervention & treatment). Several
studies have demonstrated that teachers can successfully deliver whole-school or
whole-class-based interventions targeting universal mental health prevention and promotion in
resource-constrained settings. Far fewer efforts though have been undertaken to evaluate the
possibility of Tier 3 interventions in which teachers directly provide care to select
children-in-need. Teachers in an HIC have been able to feasibly deliver a subset of
therapeutic techniques to children diagnosed with Conduct Disorder and an ongoing study in
Kenya has shown teacher-delivered Trauma-focused-Cognitive Behavioral Therapy for children
who have experienced parental death is feasible and acceptable. While these studies suggest
promise for teacher-delivered indicated care, teachers in these handful of studies delivered
prescribed, manualized care. While such a structure is at the heart of task-shifted care for
adults and adolescents, it differs from the typical Tier 1 and Tier 2 structure that is
either whole-school or whole-class-based.6 It may be that few interventions study teachers
delivering Tier 3 care as the typical Tier 3 structure, predominantly one-on-one sessions, is
not conducive to teachers delivering care on top of their typical duties. Further, the care
in these studies focuses on singular diagnoses, limiting the teacher-lay counselors' reach.
Given the limited time teacher-lay counselors would have to deliver indicated care, a
transdiagnostic approach would maximize the children and categories of struggles teachers
could reach while potentially minimizing the amount of training teachers would need to
deliver such care.
To address this gap, the research team has developed a novel intervention, Tealeaf, to
task-shift to to teachers the delivery of care to indicated school-aged children facing
mental distress. Tealeaf is unique in that teachers deliver care utilizing a
trans-diagnostic, non-manualized, evidence-based approach that they can customize and
integrate into their existing workflows. In work preceding this trial, members of this
research group conducted studies in rural Darjeeling to assess the feasibility, acceptability
and potential efficacy of Tealeaf.
Through this work, the research team has documented an emergent therapy modality that they
have called "education as mental health therapy" (Ed-MH). Ed-MH relies on teachers shifting
their professional practice to incorporate mental health techniques into their workflow with
the primary goal of improving individual children's mental wellbeing. Transdiagnostic,
indicated mental health care that is primarily incorporated into existing workflows is
feasible for teachers to deliver and acceptable to teachers, caregivers, and children.
Further, the research team has established strong face validity for the efficacy of Tealeaf.
Children receiving this care have consistently demonstrated significant improvement in their
mental health from baseline and an (ad-hoc) showed substantial/significant impact for
children receiving Tealeaf as compared to Enhanced Usual Care [publication forthcoming].
Finally, the potential risks associated with Tealeaf have been well evaluated and no serious
adverse events have occurred over multiple years of piloting. Overall, the research team's
prior research demonstrates that teacher-delivered transdiagnostic mental health care (Ed-MH)
may be a potentially efficient, sustainable, and impactful approach. The research team
believes the next logical step is to assess the effectiveness of this care model through
real-world implementation. To accomplish this, with funding support from the Mariwala Health
Initiative, the research team will conduct a hybrid three-variable hybrid study of
effectiveness, implementation, and context. Evaluating intervention effectiveness,
implementation processes and outcomes, and the context in which it occurs will generate
valuable insight into how children's mental health care can best be delivered in
resource-limited settings.
