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

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Suicide

Treatments: Behavioral: Enhanced usual care; Behavioral: SAFETY

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00692302

DSIR 84 CT-S

R34MH078082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

SAFETY I

Experimental group

Description:

Phase I participants who will receive SAFETY

Treatment:

Behavioral: SAFETY

SAFETY II

Experimental group

Description:

Phase II participants who will receive SAFETY

Treatment:

Behavioral: SAFETY

Control

Active Comparator group

Description:

Phase II participants who will receive enhanced usual care

Treatment:

Behavioral: Enhanced usual care