SuicideNCT05346133
Adapting the Suicide Safety Planning Intervention for Delivery to Adolescents in Mozambican Primary Care Settings
A study testing Suicide Prevention Intervention for Adolescents in people with Suicide and Adolescent Behavior, run by Columbia University at 2 sites in Mozambique.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Adolescent Behavior
- What is being tested?
- Suicide Prevention Intervention for Adolescents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesMozambique
- Study dates
- 18 Apr 2022to 8 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
- Parent or guardian of participating adolescent
- Present with adolescent at intervention clinics
Show all 9Show fewer
- Portuguese-speaking
- Provide permission for adolescent participation Provide informed consent
- Providers in adolescent services at intervention clinics
Who cannot join
- Having acute illness which requires immediate continued care
- Lacking lack of capacity/cognitive impairment for assent
- Caretaker:
- Lacking lack of capacity/cognitive impairment for assent
- Provider:
Trial locations and contacts
2 sites in 1 country.
Mozambique2 sites
Centro de Saude Alto Mae
Maputo
Centro de Saude Bagamoio
Maputo
About this study
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.
Read the 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.
- Conditions
- Suicide, Adolescent Behavior
- Being tested
- Suicide Prevention Intervention for Adolescents
- Medical subject headings
- Suicide, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide Prevention Intervention for AdolescentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Suicide Prevention Intervention for Adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Secondary outcomes (1)
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."
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start18 Apr 2022
- Primary completion18 Oct 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kathryn L. Lovero, PhD, Columbia University
- Investigators
- Kate Lovero, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346133
- Sponsor's protocol ID
- 8129
- Other IDs
- K01MH120258
- Status last verified
- Feb 2023
- First submitted
- 13 Apr 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the Suicide Safety Planning Intervention for Delivery to Adolescents in Mozambican Primary Care Settings
- ClinicalTrials.gov ID
- NCT05346133
- Acronym / sponsor ID
- 8129
- Conditions
- Suicide, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPI-A Adolescents | Other | Behavioral: Suicide Prevention Intervention for AdolescentsAdolescents 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. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
- Parent or guardian of participating adolescent
Key exclusion criteria (5 listed)
- Having acute illness which requires immediate continued care
- Lacking lack of capacity/cognitive impairment for assent
- Lacking lack of capacity/cognitive impairment for assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suicide Prevention Intervention for AdolescentsSuicide 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. | Behavioural | SPI-A Adolescents |
Primary outcome
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).
1 secondary outcome
Frequency of Suicide Safety Plan use
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Lovero, PhD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suicide Prevention Intervention for Adolescents in people with Suicide and Adolescent Behavior, run by Columbia University at 2 sites in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicide risk (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.