NCT00692302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2019

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

9.9 years

First QC Date

June 4, 2008

Last Update Submit

March 24, 2025

Conditions

Suicide

Keywords

Suicide AttemptsAdolescentsSuicidalAdolescent Suicide Attempters

Outcome Measures

Primary Outcomes (2)

  • 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

Other Outcomes (10)

  • Suicide Attempts

    3-months

  • Suicide-related hospitalizations

    3-months

  • Suicide-related ED Visits

    3-Months

  • +7 more other outcomes

Study Arms (3)

SAFETY I

EXPERIMENTAL

Phase I participants who will receive SAFETY

Behavioral: SAFETY

SAFETY II

EXPERIMENTAL

Phase II participants who will receive SAFETY

Behavioral: SAFETY

Control

ACTIVE COMPARATOR

Phase II participants who will receive enhanced usual care

Behavioral: Enhanced usual care

Interventions

SAFETYBEHAVIORAL

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 ISAFETY II
Enhanced usual careBEHAVIORAL

Enhanced usual care will include treatment as usual enhanced by study support.

Control

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Suicide attempt or repetitive self-harm in the 3 months before study entry

You may not qualify if:

  • Psychosis
  • Substance dependency
  • Immediate risk of out-of-home placement
  • Symptoms/conditions that would interfere with assessment and/or intervention protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

Los Angeles, California, 90024, United States

Location

Related Publications (3)

  • 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.

    PMID: 28545756RESULT

  • 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.

    PMID: 25255931RESULT

  • 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.

    PMID: 31350782RESULT

Related Links

MeSH Terms

Conditions

SuicideSuicide, Attempted

Interventions

Safety

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Accident PreventionAccidentsPublic HealthEnvironment and Public Health

Study Officials

  • Joan R. Asarnow, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry & Biobehavioral Sciences

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

March 1, 2006

Primary Completion

February 1, 2016

Study Completion

October 18, 2019

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

US(1)