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Clinical Trials/NCT05346133
NCT05346133
Completed
Not Applicable

Adapting the Suicide Safety Planning Intervention for Delivery to Adolescents in Mozambican Primary Care Settings

Columbia University2 sites in 1 country230 target enrollmentApril 18, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide
Sponsor
Columbia University
Enrollment
230
Locations
2
Primary Endpoint
Change in suicide risk
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

The investigators will provide a day-long training in SPI-A to 12 adolescent healthcare providers at 2 primary care clinics. Following the training, the providers will participate in a workshop with the research team to adapt SPI-A to their clinic setting, focusing on any SPI-A content modifications required for local adolescents (e.g. relevant examples of suicide risk warning signs), developing procedures for safe management of adolescents with imminent suicide risk in their clinic, strategies for engaging caregivers, and follow-up procedures. Providers will then be certified in SPI-A following 6-weeks of supervision. After providers are certified in SPI-A, the intervention will be pilot tested in their primary care facilities. Providers will use a standardized questionnaire to screen included adolescents for suicide risk at the end of their clinic visit. 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 (psychologist or psychiatrist) at the primary care clinic. Enrollment of participants will continue until each of the 12 primary care providers has completed SPI-A with 2 adolescents (n=24 adolescents completing SPI-A in total). Based on previous research exploring the prevalence of suicide risk in this adolescent population, the investigators anticipate needing to include 200 adolescents in total to be screened for suicide risk to identify 24 with moderate risk that will participate in SPI-A. 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. The goal of the trial is to determine 1) how primary care providers feel about delivering SPI-A, 2) how adolescents feel about participating in SPI-A, and 3) whether SPI-A results in reduced suicide risk levels in Mozambican adolescents.

Registry
clinicaltrials.gov
Start Date
April 18, 2022
End Date
December 8, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathryn L. Lovero, PhD

Assistant Professor of Sociomedical Sciences

Columbia University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in suicide risk

Time Frame: 1 month

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).

Secondary Outcomes

  • Frequency of Suicide Safety Plan use(1 month)

Study Sites (2)

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