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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH078082 | U.S. NIH Grant/Contract | View source | |
| DSIR 84 CT-S |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of an individually tailored suicide prevention treatment program called SAFETY in reducing suicide and suicide attempts in adolescents.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAFETY I | Experimental | Phase I participants who will receive SAFETY |
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| SAFETY II | Experimental | Phase II participants who will receive SAFETY |
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| Control | Active Comparator | Phase II participants who will receive enhanced usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAFETY | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Attempt | Derived from adapted C-SSRS that incorporates questions from the Suicide History Interview | 3-months |
| Suicide-related hospitalizations | SACA, adapted | Measured at month 3 |
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| Measure | Description | Time Frame |
|---|---|---|
| Suicide Attempts | Derived from adapted C-SSRS that incorporates questions from the Suicide History Interview | 3-months |
| Suicide-related hospitalizations | SACA, adapted |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan R. Asarnow, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Los Angeles | California | 90024 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28545756 | Result | 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. | |
| 25255931 | Result | 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. |
| Label | URL |
|---|---|
| Center for Trauma-Informed Adolescent Suicide, Self-harm \& Substance Abuse Treatment \& Prevention | View source |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012449 | Safety |
| ID | Term |
|---|---|
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Enhanced usual care | Behavioral | Enhanced usual care will include treatment as usual enhanced by study support. |
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| 3-months |
| Suicide-related ED Visits | SACA, adapted | 3-Months |
| Suicide-related ED visits | SACA, adapted | Final assessment |
| Youth Depression | CES-D | 3-months |
| Youth Hopelessness | BHS | 3-months |
| Parent Depression | CES-D | 3 Months |
| Parent Hopelessness | BHS | 3 Months |
| Youth Suicidality (Ideation and Behavior) | HASS | 3 months |
| Youth Social Adjustment | SAS-SR for Youth | 3 months |
| 31350782 | Result | 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. |