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Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)
This study is currently recruiting participants.
Study NCT00692302   Information provided by National Institute of Mental Health (NIMH)
First Received: June 4, 2008   Last Updated: March 9, 2009   History of Changes

June 4, 2008
March 9, 2009
March 2006
February 2010   (final data collection date for primary outcome measure)
  • Hospitalization [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: Yes ]
  • Repeat suicide attempts [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: Yes ]
  • Satisfaction with mental health services [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00692302 on ClinicalTrials.gov Archive Site
 
 
 
Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)
Family Based Intervention for Adolescent Suicide Attempters

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

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Suicide
  • Behavioral: SAFETY
  • Behavioral: Enhanced usual care
  • Experimental: Phase I participants who will receive SAFETY
  • Experimental: Phase II participants who will receive SAFETY
  • Active Comparator: Phase II participants who will receive enhanced usual care
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Suicide attempt 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
Both
12 Years to 19 Years
No
Contact: Joan R. Asarnow, PhD 310-794-4962
United States
 
NCT00692302
Joan Rosenbaum Asarnow, PhD, University of California, Los Angeles
R34 MH078082, DSIR 84 CT-S
National Institute of Mental Health (NIMH)
 
Principal Investigator: Joan R. Asarnow, PhD University of California, Los Angeles
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP