Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)
Recruitment status was Recruiting
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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 |
- 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: | February 2010 |
| Estimated Primary Completion Date: | February 2010 (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 |
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| 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 |
More Information
No publications provided
| Responsible Party: | Joan Rosenbaum Asarnow, PhD, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00692302 History of Changes |
| Other Study ID Numbers: | R34 MH078082, DSIR 84 CT-S |
| Study First Received: | June 4, 2008 |
| Last Updated: | March 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Suicide Attempts Adolescents Suicidal Adolescent Suicide Attempters |
Additional relevant MeSH terms:
|
Suicide Self-Injurious Behavior Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013