Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-29 @ 12:04 PM
Study NCT ID:
NCT05346133
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2022-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adapting the Suicide Safety Planning Intervention for Delivery to Adolescents in Mozambican Primary Care Settings
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Adapting the Suicide Safety Planning Intervention for Delivery to Adolescents in Mozambican Primary Care Settings
Status:
COMPLETED
Status Verified Date:
2023-02
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K01MH120258 | NIH | None | https://reporter.nih.gov/quic… | View |