Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)
Primary Purpose
Suicide
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAFETY
Enhanced usual care
Sponsored by
About this trial
This is an interventional treatment trial for Suicide focused on measuring Suicide Attempts, Adolescents, Suicidal, Adolescent Suicide Attempters
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
Sites / Locations
- University of CaliforniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
SAFETY I
SAFETY II
Control
Arm Description
Phase I participants who will receive SAFETY
Phase II participants who will receive SAFETY
Phase II participants who will receive enhanced usual care
Outcomes
Primary Outcome Measures
Hospitalization
Repeat suicide attempts
Satisfaction with mental health services
Secondary Outcome Measures
Full Information
NCT ID
NCT00692302
First Posted
June 4, 2008
Last Updated
June 5, 2013
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00692302
Brief Title
Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)
Official Title
Family Based Intervention for Adolescent Suicide Attempters
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide Attempts, Adolescents, Suicidal, Adolescent Suicide Attempters
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SAFETY I
Arm Type
Experimental
Arm Description
Phase I participants who will receive SAFETY
Arm Title
SAFETY II
Arm Type
Experimental
Arm Description
Phase II participants who will receive SAFETY
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Phase II participants who will receive enhanced usual care
Intervention Type
Behavioral
Intervention Name(s)
SAFETY
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Intervention Description
Enhanced usual care will include treatment as usual enhanced by study support.
Primary Outcome Measure Information:
Title
Hospitalization
Time Frame
Measured at Month 3
Title
Repeat suicide attempts
Time Frame
Measured at Month 3
Title
Satisfaction with mental health services
Time Frame
Measured at Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan R. Asarnow, PhD
Phone
310-794-4962
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan R. Asarnow, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan R. Asarnow, PhD
Phone
310-794-4962
First Name & Middle Initial & Last Name & Degree
Joan R. Asarnow, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
28545756
Citation
Asarnow JR, Hughes JL, Babeva KN, Sugar CA. Cognitive-Behavioral Family Treatment for Suicide Attempt Prevention: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):506-514. doi: 10.1016/j.jaac.2017.03.015. Epub 2017 Apr 5.
Results Reference
derived
PubMed Identifier
25255931
Citation
Asarnow JR, Berk M, Hughes JL, Anderson NL. The SAFETY Program: a treatment-development trial of a cognitive-behavioral family treatment for adolescent suicide attempters. J Clin Child Adolesc Psychol. 2015;44(1):194-203. doi: 10.1080/15374416.2014.940624. Epub 2014 Sep 25.
Results Reference
derived
Learn more about this trial
Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)
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