NCT05346133

Brief Summary

Globally, suicide is ranked as the second leading cause of death for youth ages 10-24 years, and more than 75% of all deaths by suicide occur in low- and middle-income countries (LMIC). However, the vast majority of adolescents in LMIC do not have access to mental health care, and contextually appropriate strategies for delivering evidence-based interventions for managing suicide risk are needed to expand services to these areas. In the present study, the investigators will adapt and pilot test the Suicide Safety Planning Intervention for Adolescents (SPI-A) delivered by primary care providers in Mozambique, an LMIC in southeastern Africa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

April 13, 2022

Last Update Submit

February 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in suicide risk

    Measuring change in suicide risk as measured by the "Columbia-Suicide Severity Rating Scale" (abbreviated as C-SSRS) at baseline (inclusion) and after 1 month. Scores range from 1-3 with 1 being low risk (the better outcome), 2 being moderate risk, and 3 being high risk (the worse outcome).

    1 month

Secondary Outcomes (1)

  • Frequency of Suicide Safety Plan use

    1 month

Other Outcomes (1)

  • Frequency of use of specific coping behaviors.

    1 month

Study Arms (1)

SPI-A Adolescents

OTHER

Adolescents with moderate risk will receive the SPI-A intervention from the provider. Adolescents with high risk will be immediately taken to the mental health specialist at the primary care clinic. Following creation of the safety plan, patients are followed-up with at least twice to assess risk and review their plan. Following completion of the pilot, the investigators will interview all included providers as well as 18 adolescents who participated in SPI-A and their caregivers.

Behavioral: Suicide Prevention Intervention for Adolescents

Interventions

Suicide Safety Planning Intervention (SPI). SPI is a very brief intervention (20-45 minutes) that provides patients with specific strategies to use to decrease the risk of suicidal behavior. SPI begins with psychoeducation about suicide risk, then the clinician and patient collaboratively create a stepwise plan that includes a simple list of individually tailored, concrete coping mechanisms to be enacted during or leading up to a crisis. The 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. SPI providers work with caregivers to help them monitor warning signs of suicide risk, encourage the use of the safety plan by their adolescent, and reduce access to lethal means in the home.

SPI-A Adolescents

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 12-19
  • Portuguese-speaking
  • Provide informed assent (ages 12-17) or consent (ages 18-19)
  • Caregiver provides permission to participate (ages 12-17) Interview Interview

You may not qualify if:

  • Having acute illness which requires immediate continued care
  • Lacking lack of capacity/cognitive impairment for assent
  • Caretaker:
  • Parent or guardian of participating adolescent
  • Present with adolescent at intervention clinics
  • Portuguese-speaking
  • Provide permission for adolescent participation Provide informed consent
  • Lacking lack of capacity/cognitive impairment for assent
  • Provider:
  • \- Providers in adolescent services at intervention clinics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Saude Alto Mae

Maputo, Mozambique

Location

Centro de Saude Bagamoio

Maputo, Mozambique

Location

MeSH Terms

Conditions

SuicideAdolescent Behavior

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Kate Lovero, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Sociomedical Sciences

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 26, 2022

Study Start

April 18, 2022

Primary Completion

October 18, 2022

Study Completion

December 8, 2022

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations