Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465381
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-11
Brief Title:
Safety Planning and Cognitive Behavioral Therapy for Adolescent Suicide Prevention in Mozambique
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Safety Planning and Cognitive Behavioral Therapy for Adolescent Suicide Prevention in Mozambique A Hybrid EffectivenessImplementation Cluster Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 andor 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 HIVAIDS 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 ideationdepressive 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 barriersfacilitators 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 highestlowest effectivenessimplementation 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 schooluniversity-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
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 andor 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 HIVAIDS 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 ideationdepressive 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 barriersfacilitators 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 highestlowest effectivenessimplementation 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 schooluniversity-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH134882 | NIH | None | None |