Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06465381 |
Other study ID # |
STUDY00019158 |
Secondary ID |
R01MH134882 |
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2025 |
Est. completion date |
March 31, 2029 |
Study information
Verified date |
June 2024 |
Source |
University of Washington |
Contact |
Morgan Turner, LICSW |
Phone |
206-543-8382 |
Email |
morgank2[@]uw.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This implementation research project aims to test the effectiveness and implementation
outcomes of suicide safety planning along and a transdiagnostic cognitive behavioral
intervention for suicide prevention on decreasing suicidal behaviors in secondary school
students in Mozambique. This study will also result in hypothesized mechanisms of
intervention effects, costs and cost-effectiveness.
Description:
More than 75% of suicide deaths occur in low-and middle-income countries (LMICs) and almost
90% of adolescents who die by suicide live in LMICs. Globally, suicide is the fourth leading
cause of death for youth and young adults aged 15-29. The African WHO region has the highest
age-standardized suicide rates in the world, with countries like Mozambique having suicide
rates almost three times the global average. Six of the top 10 countries by suicide rates in
the world are in the African region. Despite this, there are few to no evidence-based
adolescent suicide prevention packages developed for, and tested in, the African context.
This is an urgent need to safeguard the well-being of youth and young adults.
Data from the investigative team suggest that 15-25% of high school students in Mozambique
are experiencing current suicidal ideation (SI), ~40% of those with ideation have past month
suicidal behavior (SB), and 9% have had a lifetime suicide attempt. Approximately 50% of
youth expressing SI or SB also express clinically significant symptoms of depression,
anxiety, and/or PTSD. To address this problem, the proposed work builds upon innovations in
the field and a decades-long partnership between the University of Washington and government
partners in Mozambique. First, while the Suicide Safety Planning Intervention (SPI) has
evidence in high-income contexts, investigators have conducted what the investigators believe
to be the first pilot of SPI among adolescents 12-19 in the African region and found it
feasible for delivery by non-specialists and acceptable by adolescents. Second, the
investigative team adapted and demonstrated the feasibility, acceptability, and initial
effectiveness of the Common Elements Treatment Approach (CETA), a transdiagnostic CBT-based
therapy delivered by non-specialists in Mozambique. For young adults aged 18-24, CETA was
shown to decrease depressive symptoms by 80% and reduce suicidal ideation from 20% to <3% by
visit five. The results of this work have led to the national scale-up of CETA in HIV/AIDS
settings in Mozambique. The investigators believe that these two evidence-based practices,
both with demonstrated feasibility in Mozambique, have the potential to be powerful
interventions to prevent adolescent suicidal behavior. Yet, a recent meta-analysis found
lower comorbidity of psychiatric disorders and suicidal behavior in LMICs (~50%) compared to
high-income countries (~90%). Therefore, it is possible that applying CETA to address
psychiatric symptoms may not lead to significant decreases in suicidal behavior above and
beyond SPI alone. For these reasons, the investigators propose to test both SPI alone and the
integration of SPI into CETA - adapted for adolescent suicide prevention - to create a
transdiagnostic CBT intervention for suicide (TCBT-S) delivered by non-specialists in
Mozambican secondary schools. Due to limited resources for mental health in the African
region the investigators aim to test whether the potential gains in effectiveness with the
more resource intensive TCBT-S justify its scale-up versus the brief SPI intervention. This
study will also generate evidence on costs, implementation determinants, and potential
mechanisms of intervention effects to optimize intervention components and implementation
strategies for future scale-up, if effective. The specific aims are to:
Specific Aim 1: Test the effectiveness of SPI and TCBT-S for decreasing suicidal behaviors,
compared to Enhanced Usual Care (EUC). Using a three-arm parallel cluster RCT the
investigators will randomize 7 secondary schools each to EUC, SPI, and TCBT-S (21 schools
total) to evaluate effects on suicidal behaviors (primary) and suicidal ideation/depressive
symptoms (secondary). EUC will involve screening and active referral to government youth
friendly mental health service programs. Exploratory analyses will examine mechanisms of
intervention effects.
Specific Aim 2: Assess implementation outcomes and determinants (barriers/facilitators) to
EUC, SPI, and TCBT-S implementation using the RE-AIM evaluation framework. RE-AIM domains
will be populated separately and compared across arms. The investigators will conduct a
sequential quantitative to qualitative explanatory analysis - organized around the
Consolidated Framework for Implementation Research - among individuals and clusters with
highest/lowest effectiveness/implementation outcomes to explore determinants of
implementation.
Specific Aim 3: Estimate the cost and cost-effectiveness of SPI and TCBT-S, compared to EUC.
The investigators will conduct micro-costing and time-and-motion observation separately for
each study arm to estimate incremental costs of implementing each intervention. The
investigators will construct a Markov model parameterized with cost and trial outcomes data
to project budget impact and cost-effectiveness for scale-up to provincial and national
levels.
This proposal is innovative in being one of the first to rigorously test suicide prevention
interventions among African adolescents. In response to the NOSI for Youth Suicide in LMICs
(NOT-MH-21-090), this project proposes to test "prevention strategies to reduce suicide risk
and promote resilience among young people aged10-24 years in LMICs". Specifically, this study
"integrates suicide prevention strategies within existing community-level platforms such as
school/university-based programs" and includes analyses to "determine how to improve fidelity
of implementation and economic evaluation of suicide prevention programs for young people".
If effective, SPI or TCBT-S have a large potential to be rapidly scaled up to safeguard youth
mental health in Mozambique and other similar LMICs.