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

Primary Purpose

Suicide, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
Suicide Prevention Intervention for Adolescents
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Adolescents:

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

Caretaker:

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

Provider:

Inclusion Criteria:

- Providers in adolescent services at intervention clinics

Sites / Locations

  • Centro de Saude Alto Mae
  • Centro de Saude Bagamoio

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SPI-A Adolescents

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Frequency of Suicide Safety Plan use
Frequency of Suicide Safety Plan use, measured by the question "In the past week, how often have you used your safety plan?" 1-month post inclusion. The outcomes range from 0-4, with 0 being "never" and 4 being "more than once a day."

Full Information

First Posted
April 13, 2022
Last Updated
February 10, 2023
Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05346133
Brief Title
Adapting the Suicide Safety Planning Intervention for Delivery to Adolescents in Mozambican Primary Care Settings
Official Title
Adapting the Suicide Safety Planning Intervention for Delivery to Adolescents in Mozambican Primary Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Adolescent Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPI-A Adolescents
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Suicide Prevention Intervention for Adolescents
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in suicide risk
Description
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).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Frequency of Suicide Safety Plan use
Description
Frequency of Suicide Safety Plan use, measured by the question "In the past week, how often have you used your safety plan?" 1-month post inclusion. The outcomes range from 0-4, with 0 being "never" and 4 being "more than once a day."
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Frequency of use of specific coping behaviors.
Description
Frequency of use of specific coping behaviors scores range from 0-2 with 2 being the better outcome (more use of coping behaviors). The average of scores is calculated across six of the following questions: "1. Try to tell yourself something calming or positive?", "2. Try to relax or do something calming?", "3. Think about reasons for living?", "4. Talk to a family member?", "5. Talk to a friend or another support person?", "6. Talk to a therapist, counselor, or doctor?", "7. Seek out emergency services?" with the answers options being never (0), sometimes (1), and always (2).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Adolescents: 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 Caretaker: 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 Provider: Inclusion Criteria: - Providers in adolescent services at intervention clinics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Lovero, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Saude Alto Mae
City
Maputo
Country
Mozambique
Facility Name
Centro de Saude Bagamoio
City
Maputo
Country
Mozambique

12. IPD Sharing Statement

Plan to Share IPD
No

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

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