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Clinical Trials/NCT03092271
NCT03092271
Completed
Not Applicable

Randomized Trial of Stepped Care for Suicide Prevention in Teens and Young Adults

University of California, Los Angeles2 sites in 1 country301 target enrollmentApril 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicidal Behavior
Sponsor
University of California, Los Angeles
Enrollment
301
Locations
2
Primary Endpoint
Suicide Attempt Behavior
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This randomized controlled trial will evaluate two approaches to achieving the aspirational goal of Zero Suicide within a health system: 1) Zero Suicide Best Practices initiated through a zero suicide quality improvement initiative within a health system; and 2) Zero Suicide Best Practices plus an innovative stepped care for suicide prevention intervention for adolescents and young adults that matches treatment intensity with risk levels for suicide/self-harm. ..

Detailed Description

We propose a rigorous randomized trial to evaluate an innovative stepped care for suicide prevention intervention for adolescents and young adults, compared to a zero suicide program initiated by a health system. An effective zero suicide strategy for this age group is critically needed because this is a developmental period when: 1) suicide is the second leading cause of death, accounting for more deaths than any medical illness; 2) suicidal tendencies and behaviors often first occur in this age span; 3) rates of suicide and suicide attempts increase dramatically; and 4) effective intervention can reduce risk, suffering, and costs over lifetimes. The project combines a partnership with a health system that has strong infrastructure and commitment to quality improvement for zero suicide with a research team that has successfully implemented collaborative stepped care interventions in health systems and has expertise in clinical, health services, economics, and policy research and dissemination. We will identify and enroll 300 youths ages 12-24 with elevated suicide and suicide attempt risk using a multi-stage screening process. Eligible youths will be randomized to: 1) zero suicide best practices, which emphasizes health system quality improvement (ZSQI); or 2) ZSQI plus stepped care for suicide prevention, which integrates evidence-based suicide prevention with primary care and emergency services. Prior research demonstrates the value of similar integrated medical-behavioral health interventions for improving patient outcomes, rates of care, and continuity of care- a critical issue for zero suicide efforts, as many youths discontinue care prematurely despite continuing risk. The ZSQI plus stepped care for suicide prevention approach uses: 1) risk assessments to triage youths to appropriate care levels; 2) care managers to deliver cognitive behavior therapy and dialectical behavior therapy skills training and support primary care and emergency clinicians with patient evaluation and treatment; 3) internet-delivered cognitive-behavior therapy and dialectical behavior therapy treatment components plus access to coaching support for lower risk youths, with stepped up in-person group and/or individual treatment added for higher risk youths; and 4) regular monitoring of patient outcomes, with feedback to clinicians to facilitate decision-making and use of the stepped care algorithms. The intervention period is 12 months: 6 months of acute treatment; and 6 months of continuation treatment. Results will provide critical information for health systems and science regarding the potential to achieve zero suicide goals by integrating state of the art science with practice quality improvement.

Registry
clinicaltrials.gov
Start Date
April 3, 2017
End Date
March 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joan Asarnow

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Presence during past year of a suicide attempt, interrupted suicide attempt, aborted suicide attempt, or active suicidal ideation with a plan; or 2) past year depression, plus a history of a suicide attempt and/or recurrent self-harm;
  • Age 12-24 years

Exclusion Criteria

  • Mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; drug dependence)
  • Life threatening medical illness or other characteristics that would impede study participation (e.g. plans to move from Oregon during study period; plans for placement out of the home, insufficient locator information for follow-up)
  • Youth receives majority of mental health care outside of the Kaiser-Permanente health system.

Outcomes

Primary Outcomes

Suicide Attempt Behavior

Time Frame: 12-month observation period

fatal and nonfatal suicide attempts/suicide attempt behaviors

Secondary Outcomes

  • Suicide Events(12-month observation period)
  • Self Harm Episodes(12-month observation period)
  • Suicidality(12-month observation period)
  • Depression(12-month observation period)

Study Sites (2)

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