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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of California, Los Angeles
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joan Asarnow, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00692302
First received: June 4, 2008
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Suicide
Behavioral: SAFETY
Behavioral: Enhanced usual care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family Based Intervention for Adolescent Suicide Attempters

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: March 2006
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAFETY I
Phase I participants who will receive SAFETY
Behavioral: SAFETY
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.
Experimental: SAFETY II
Phase II participants who will receive SAFETY
Behavioral: SAFETY
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.
Active Comparator: Control
Phase II participants who will receive enhanced usual care
Behavioral: Enhanced usual care
Enhanced usual care will include treatment as usual enhanced by study support.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692302

Contacts
Contact: Joan R. Asarnow, PhD 310-794-4962

Locations
United States, California
University of California Recruiting
Los Angeles, California, United States, 90024
Contact: Joan R. Asarnow, PhD    310-794-4962      
Principal Investigator: Joan R. Asarnow, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Joan R. Asarnow, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Joan Asarnow, Professor of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00692302     History of Changes
Other Study ID Numbers: R34 MH078082, R34MH078082, DSIR 84 CT-S
Study First Received: June 4, 2008
Last Updated: June 5, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Suicide Attempts
Adolescents
Suicidal
Adolescent Suicide Attempters

Additional relevant MeSH terms:
Suicide
Behavioral Symptoms
Self-Injurious Behavior

ClinicalTrials.gov processed this record on November 20, 2014