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Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)

Family Based Intervention for Adolescent Suicide Attempters

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00692302
Enrollment
72
Registered
2008-06-06
Start date
2006-03-31
Completion date
2019-10-18
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

Suicide Attempts, Adolescents, Suicidal, Adolescent Suicide Attempters

Brief summary

This study will evaluate the effectiveness of an individually tailored suicide prevention treatment program called SAFETY in reducing suicide and suicide attempts in adolescents.

Detailed description

Suicide is consistently a leading cause of death among adolescents in the United States, making suicide prevention a serious public health concern. The risk factors for suicide vary but are often related to depression and other mental disorders, substance abuse, a major stressful event, and family history of suicide. Despite the morbidity and mortality associated with suicide attempts in adolescents, there is a lack of empirically supported treatment strategies and consensus regarding the best practices for suicide prevention. The SAFETY intervention is an individually tailored treatment strategy that integrates family- and community-based interventions and cognitive behavioral therapy and links youth to needed services and resources. SAFETY may be an effective means of reducing suicide attempts and improving mental health in at-risk adolescents. This study will evaluate the effectiveness of SAFETY in reducing suicide and suicide attempts in adolescents. This study will be divided into two phases. Participants in Phase I will all receive 12 weeks of the family-based cognitive behavioral therapy intervention SAFETY. Phase I will be used to develop the intervention manual, protocols, and adherence measures for SAFETY in Phase II. Phase I participants will undergo assessments at baseline and Week 12. Assessments will last 90 minutes and will include a series of interviews and questionnaires concerning family, general health, and mental health-related issues. Participants in Phase II will be assigned randomly to receive 12 weeks of SAFETY or enhanced usual care. The frequency of sessions, which will involve both youth and parent participants, will vary on the basis of the individual needs of participants. SAFETY sessions will be individually tailored for each participant's specific needs and will include the following elements: (1) family- and community-based interventions aimed at mobilizing family and community networks that support youth safety, adaptive behavior, and reasons for living; (2) cognitive behavioral treatment modules that focus on decreasing suicidality and preventing repeat suicide attempts; and (3) an individualized care linkage strategy that links youth to needed services and resources. At baseline, Week 12, and Month 6, all youth and parent participants will undergo the same assessments that were performed during Phase I.

Interventions

BEHAVIORALSAFETY

Participants will receive a family-based cognitive behavioral therapy intervention called SAFETY for 12 weeks. The SAFETY intervention is an individually tailored intervention strategy that integrates (1) family- and community-based interventions aimed at mobilizing family and community networks that support youth safety, adaptive behavior, and reasons for living; (2) cognitive behavioral treatment modules that focus on decreasing suicidality and preventing repeat suicide attempts; and (3) an individualized care linkage strategy that links youth to needed services and resources.

BEHAVIORALEnhanced usual care

Enhanced usual care will include treatment as usual enhanced by study support.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

* Suicide attempt or repetitive self-harm in the 3 months before study entry

Exclusion criteria

* Psychosis * Substance dependency * Immediate risk of out-of-home placement * Symptoms/conditions that would interfere with assessment and/or intervention protocols

Design outcomes

Primary

MeasureTime frameDescription
Suicide Attempt3-monthsDerived from adapted C-SSRS that incorporates questions from the Suicide History Interview
Suicide-related hospitalizationsMeasured at month 3SACA, adapted

Other

MeasureTime frameDescription
Suicide-related ED Visits3-MonthsSACA, adapted
Suicide-related ED visitsFinal assessmentSACA, adapted
Youth Depression3-monthsCES-D
Youth Hopelessness3-monthsBHS
Suicide Attempts3-monthsDerived from adapted C-SSRS that incorporates questions from the Suicide History Interview
Parent Hopelessness3 MonthsBHS
Youth Suicidality (Ideation and Behavior)3 monthsHASS
Youth Social Adjustment3 monthsSAS-SR for Youth
Parent Depression3 MonthsCES-D
Suicide-related hospitalizations3-monthsSACA, adapted

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026