Clinical trial NCT00692302: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Suicide
Keywords: Suicide Attempts
Adolescents
Suicidal
Adolescent Suicide Attempters
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-06-06
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Suicide attempt or repetitive self-harm 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

Primary outcomes:
measure: Suicide Attempt
timeFrame: 3-months
measure: Suicide-related hospitalizations
timeFrame: Measured at month 3
Secondary outcomes:
Other outcomes:
measure: Suicide Attempts
timeFrame: 3-months
measure: Suicide-related hospitalizations
timeFrame: 3-months
measure: Suicide-related ED Visits
timeFrame: 3-Months
measure: Suicide-related ED visits
timeFrame: Final assessment
measure: Youth Depression
timeFrame: 3-months
measure: Youth Hopelessness
timeFrame: 3-months
measure: Parent Depression
timeFrame: 3 Months
measure: Parent Hopelessness
timeFrame: 3 Months
measure: Youth Suicidality (Ideation and Behavior)
timeFrame: 3 months
measure: Youth Social Adjustment
timeFrame: 3 months
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Joan R. Asarnow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Babeva KN, Klomhaus AM, Sugar CA, Fitzpatrick O, Asarnow JR. Adolescent Suicide Attempt Prevention: Predictors of Response to a Cognitive-Behavioral Family and Youth Centered Intervention. Suicide Life Threat Behav. 2020 Feb;50(1):56-71. doi: 10.1111/sltb.12573. Epub 2019 Jul 26.