Clinical trial NCT05346133: 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
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Adolescent Behavior
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-04-26
Enrollment: 230
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in suicide risk
timeFrame: 1 month
Secondary outcomes:
measure: Frequency of Suicide Safety Plan use
timeFrame: 1 month
Other outcomes:
measure: Frequency of use of specific coping behaviors.
timeFrame: 1 month
Locations:
city: Maputo
country: Mozambique
facility: Centro de Saude Alto Mae
city: Maputo
country: Mozambique
facility: Centro de Saude Bagamoio
Study officials:
affiliation: Columbia University
name: Kate Lovero, PhD
role: PRINCIPAL_INVESTIGATOR
References: