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

Phase 1
Completed
Conditions
Suicide
Interventions
Behavioral: SAFETY
Behavioral: Enhanced usual care
Registration Number
NCT00692302
Lead Sponsor
University of California, Los Angeles
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
72
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SAFETY ISAFETYPhase I participants who will receive SAFETY
SAFETY IISAFETYPhase II participants who will receive SAFETY
ControlEnhanced usual carePhase II participants who will receive enhanced usual care
Primary Outcome Measures
NameTimeMethod
Suicide Attempt3-months

Derived from adapted C-SSRS that incorporates questions from the Suicide History Interview

Suicide-related hospitalizationsMeasured at month 3

SACA, adapted

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of California

🇺🇸

Los Angeles, California, United States

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