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Trial record 41 of 6084 for:    zero

Randomized Trial of Stepped Care for Suicide Prevention in Teens and Young Adults (Step2Health)

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ClinicalTrials.gov Identifier: NCT03092271
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Kaiser Foundation Research Institute
University of Washington
Information provided by (Responsible Party):
Joan Asarnow, University of California, Los Angeles

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. ..

Condition or disease Intervention/treatment Phase
Suicidal Behavior Self-Harm, Deliberate Suicidal Ideation Suicide Behavioral: Stepped Care for Suicide Prevention Behavioral: Zero Suicide Quality Improvement Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to one of two conditions: 1) Zero suicide Best Practices/Quality Improvement; or 2) Zero suicide Best Practices/Quality Improvement plus stepped care for suicide prevention intervention
Masking: Single (Outcomes Assessor)
Masking Description: Assessments will be conducted by assessors who are naive to randomization assignment. Every effort will be made to conceal all information regarding randomization and randomization assignment to staff involved in assessment, recruitment, or other study activities that could lead to bias. It is not possible to conceal randomization status from intervention staff, as they will be delivering the intervention.
Primary Purpose: Prevention
Official Title: Randomized Trial of Stepped Care for Suicide Prevention in Teens and Young Adults
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Active Comparator: Zero Suicide Quality Improvement (ZSQI)
Zero suicide best practices as implemented through a health system zero suicide quality improvement initiative
Behavioral: Zero Suicide Quality Improvement
ZSQI

Experimental: Stepped Care for Suicide Prevention
ZSQI plus a stepped care intervention that matches intensity of services to youth risk level.
Behavioral: Stepped Care for Suicide Prevention
ZSQI plus Stepped Care for Suicide Prevention

Behavioral: Zero Suicide Quality Improvement
ZSQI




Primary Outcome Measures :
  1. Suicide Attempt Behavior [ Time Frame: 12-month observation period ]
    fatal and nonfatal suicide attempts/suicide attempt behaviors


Secondary Outcome Measures :
  1. Suicide Events [ Time Frame: 12-month observation period ]
    fatal and nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, active suicidal ideation

  2. Self Harm Episodes [ Time Frame: 12-month observation period ]
    suicide attempts, undetermined self-harm, and nonsuicidal self-injury

  3. Suicidality [ Time Frame: 12-month observation period ]
    Continuous measure of suicidality

  4. Depression [ Time Frame: 12-month observation period ]
    Continuous depressive symptom score



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. Age 12-24 years

Exclusion Criteria:

  1. Mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; drug dependence)
  2. 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)
  3. Youth receives majority of mental health care outside of the Kaiser-Permanente health system.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092271


Contacts
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Contact: Joan R Asarnow, PhD 310 825-0408 jasarnow@mednet.ucla.edu
Contact: Gregory N Clarke (503) 335-6673 greg.clarke@kpchr.org

Locations
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United States, California
University of California Los Angeles (UCLA) Active, not recruiting
Los Angeles, California, United States, 90095-6968
United States, Oregon
Kaiser Permanente Northwest Recruiting
Portland, Oregon, United States, 97227-1098
Contact: Shelley Reetz    503-335-6359    Shelley.N.Reetz@kpchr.org   
Principal Investigator: Gregory N Clarke, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Kaiser Foundation Research Institute
University of Washington

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Responsible Party: Joan Asarnow, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03092271     History of Changes
Other Study ID Numbers: 112147
16-001594 ( Other Identifier: UCLA IRB )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only fully anonymized and de-identified data as approved by the Institutional Review Board. The study principal investigator will collaborate with National Institute of Mental Health to finalize public use dataset procedures, ensure that the rights and privacy of all individual research participants are protected, and that Protected Personal Health Information is protected as required by law and approved by the study Institutional Review Board. The plan is for a limited access database of anonymized and de-identified data to be created. This data set will be available after study papers are completed and accepted for publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joan Asarnow, University of California, Los Angeles:
suicide
suicide attempt
self harm
depression

Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms