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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00692302 |
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 |
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Suicide |
Behavioral: SAFETY Behavioral: Enhanced usual care |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Family Based Intervention for Adolescent Suicide Attempters |
Estimated Enrollment: | 60 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SAFETY I: Experimental
Phase I participants who will receive SAFETY
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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. |
SAFETY II: Experimental
Phase II participants who will receive SAFETY
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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. |
Control: Active Comparator
Phase II participants who will receive enhanced usual care
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Behavioral: Enhanced usual care
Enhanced usual care will include treatment as usual enhanced by study support.
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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.
Ages Eligible for Study: | 12 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joan R. Asarnow, PhD | 310-794-4962 |
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 |
Principal Investigator: | Joan R. Asarnow, PhD | University of California, Los Angeles |
Responsible Party: | University of California, Los Angeles ( Joan Rosenbaum Asarnow, PhD ) |
Study ID Numbers: | R34 MH078082, DSIR 84 CT-S |
Study First Received: | June 4, 2008 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00692302 History of Changes |
Health Authority: | United States: Federal Government |
Suicide Attempts Adolescents Suicidal Adolescent Suicide Attempters |
Suicide, Attempted Suicide Behavioral Symptoms Self-Injurious Behavior |
Suicide Behavioral Symptoms Self-Injurious Behavior |