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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.   Last updated on September 18, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)
Official Title  Family Based Intervention for 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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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 ]
Secondary Outcome Measure 
Condition  Suicide
Intervention  Behavioral: SAFETY
Behavioral: Enhanced usual care
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  60
Start Date  March 2006
Completion Date February 2010
Eligibility Criteria 

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
Gender Both
Ages 12 Years to 19 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Joan R. Asarnow, PhD     310-794-4962        
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00692302
Organization ID MH078082
Secondary IDs †† DSIR 84 CT-S
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Joan R. Asarnow, PhD     University of California, Los Angeles    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date September 2008
First Received Date  June 4, 2008
Last Updated Date September 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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