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Completed

NCT Number: NCT00692302

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

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

Completed

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Key information

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California

Los Angeles, California, 90024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAFETY

Behavioral

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.

Enhanced Usual Care

Behavioral

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

Primary outcomes

  1. Suicide Attempt

    Time frame: 3-months

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

  2. Suicide-related hospitalizations

    Time frame: Measured at month 3

    SACA, adapted

Other outcomes

  1. Suicide Attempts

    Time frame: 3-months

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

  2. Suicide-related hospitalizations

    Time frame: 3-months

    SACA, adapted

  3. Suicide-related ED Visits

    Time frame: 3-Months

    SACA, adapted

  4. Suicide-related ED visits

    Time frame: Final assessment

    SACA, adapted

  5. Youth Depression

    Time frame: 3-months

    CES-D

  6. Youth Hopelessness

    Time frame: 3-months

    BHS

  7. Parent Depression

    Time frame: 3 Months

    CES-D

  8. Parent Hopelessness

    Time frame: 3 Months

    BHS

  9. Youth Suicidality (Ideation and Behavior)

    Time frame: 3 months

    HASS

  10. Youth Social Adjustment

    Time frame: 3 months

    SAS-SR for Youth

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Family Based Intervention for Adolescent Suicide Attempters

Important dates

Study start
2006
Primary completion
2016
Study completion
2019
First posted
Jun 6, 2008
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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