Safety Planning and Cognitive Behavioral Therapy for Adolescent Suicide Prevention in Mozambique

NCT06465381 | Recruiting DMC

• 2 other identifiers: STUDY00019158R01MH134882
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 7

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.

Conditions

Suicide Prevention

Keywords

Suicidal Behavior; Safety Planning Intervention; Transdiagnostic Cognitive Behavioral Therapy for Suicide Prevention; Suicidal Ideation; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Suicidal Behavior

  As reported on the Columbia Suicide Severity Rating Scale. The responses of the C-SSRS tool are yes or no options that indicate the user's level of risk as low, moderate or high risk of suicide.

  6-months post intervention

Secondary Outcomes (4)

• Suicidal Behavior - Supplementary analysis of primary outcome

  3-months post intervention

• Suicidal Ideation

  3-, 6-, 12-, and 24-months post intervention

• Depressive Symptoms

  3-, 6-, 12-, and 24-months post intervention

• Suicidal Behavior - Maintenance Indicators

  12-, and 24-months post intervention

Study Arms (3)

Enhanced Usual Care

OTHER

In school randomized to EUC, youth who are determined to be high risk of suicide using the C-SSRS will be transported to the local government emergency psychiatric services that Dr. Cumbe (Co-I) directs in his role as Provincial Director of Mental Health services in Sofala Province. For students with moderate risk, they will receive information and referral to local government mental health and youth friendly services. At follow-up outcome ascertainment time points, those in the EUC arm will be re-assessed for suicide risk and uptake of referral services.

Behavioral: Enhanced Usual Care

Safety Planning Intervention

EXPERIMENTAL

If the student attends a school that has been randomized to SPI alone, youth will be asked to participate in a collaborative approach to create a stepwise safety plan that includes a simple list of individually tailored, concrete coping mechanisms to be enacted during or leading up to a crisis. The seven steps of the safety plan include: 1) recognizing warning signs of a crisis; 2) employing internal coping strategies; 3) using social contacts and settings to distract from suicidal thoughts; 4) seeking help from family members or close friends; 5) contacting healthcare or emergency services; and 6) reducing access to means. Youth will be followed-up at 2- and 4-weeks post intake to assess suicide risk and review their safety plan. Youth who are determined to be high risk of suicide using the C-SSRS will be transported to the local government emergency psychiatric services.

Behavioral: Safety Planning Intervention

Transdiagnostic Cognitive Behavioral Therapy for Suicide Prevention

EXPERIMENTAL

In schools randomized to TCBT-S, youth will receive 1) the safety planning intervention as outlined above 2) psychoeducation focused on suicidal thoughts and behaviors and how TCBT-S is expected to contribute to recovery; 3) cognitive restructuring adapted to focus on the thoughts and feelings that occur during individual's suicidal thoughts or behaviors; 4) linking the getting active module to coping strategies included in the safety plan for acute distress tolerance and crisis avoidance; and 5) problem solving focused on addressing problems believed to be contributing to suicidal thoughts and behaviors; and 6) relaxation techniques to help manage overwhelming emotions and/or physical sensations that may contribute to suicidal thoughts and behaviors. TCBT-S will be implemented in 6-8 sessions each spaced one week apart. Youth who are determined to be high risk of suicide using the C-SSRS will be transported to the local government emergency psychiatric services.

Behavioral: Transdiagnostic Cognitive Behavioral Therapy for Suicide Prevention

Interventions

Transdiagnostic Cognitive Behavioral Therapy for Suicide Prevention BEHAVIORAL

All behavioral interventions will be provided by a trained nonspecialist healthcare worker, descriptions of each intervention can be found under treatment arm/group descriptions.

Transdiagnostic Cognitive Behavioral Therapy for Suicide Prevention

Safety Planning Intervention BEHAVIORAL

All behavioral interventions will be provided by a trained nonspecialist healthcare worker, descriptions of each intervention can be found under treatment arm/group descriptions.

Safety Planning Intervention

Enhanced Usual Care BEHAVIORAL

All behavioral interventions will be provided by a trained nonspecialist healthcare worker, descriptions of each intervention can be found under treatment arm/group descriptions.

Enhanced Usual Care

Eligibility Criteria

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

You may qualify if:

• Youth enrolled in a secondary school in Sofala Province that is located within 30 minutes of a health facility that hosts both an urgent care and mental health department.
• Youth enrolled in 9th and/or 10th and/or 11th grade.
• Legal guardian has provided consent to participate if under 18 or if youth is age 18 or older and has provided consent to participate.
• Youth has assented to participation.
• \. Youth expresses active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS).

You may not qualify if:

• Youth and/or guardian has not provided consent to participate, or responsible party is unable to provide informed consent.
• Youth is not enrolled in a participating secondary school.
• Youth declines to assent.
• Youth is a ward of the State or any other agency, institution, or entity.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Washington: lead

Study Sites (7)

9 Secondary Schools

Beira, Mozambique

RECRUITING

1 Secondary School

Caia, Mozambique

RECRUITING

1 Secondary School

Cheringoma., Mozambique

RECRUITING

1 Secondary School

Chibabava, Mozambique

RECRUITING

4 Secondary Schools

Dondo, Mozambique

RECRUITING

1 Secondary School

Maringue, Mozambique

RECRUITING

4 Secondary Schools

Nhamatanda, Mozambique

RECRUITING

Related Publications (1)

• Wagenaar BH, Muanido A, Turner M, Lovero KL, Darnell D, Sharma M, Comtois KA, Ramiro I, Cumbe VFJ. Safety planning and transdiagnostic cognitive behavioral therapy for adolescent suicide prevention in Mozambique: study protocol for the SPI/TCBT-S hybrid effectiveness/implementation cluster randomized trial. BMC Psychiatry. 2025 Jul 1;25(1):656. doi: 10.1186/s12888-025-07102-w.

  PMID: 40598126 DERIVED

MeSH Terms

Conditions

Suicide Prevention; Suicidal Ideation; Depression

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Bradley Wagenaar, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Turner, LICSW

CONTACT

206-543-8382; morgank2@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Global Health

Model Details: Using a three-arm parallel cluster RCT the investigators will randomize 7 secondary schools each to enhanced usual care, Safety Planning Intervention, and Transdiagnostic Cognitive Behavioral Therapy for Suicide prevention (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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 18, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

MO (7)