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Suicidal BehaviorStep2HealthNCT03092271

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

A study testing Stepped Care for Suicide Prevention and Zero Suicide Quality Improvement in people with Suicidal Behavior and Self-Harm, Deliberate, run by University of California, Los Angeles at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 12 to 24 years
What is being tested?
Stepped Care for Suicide Prevention and Zero Suicide Quality Improvement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
2 sitesUnited States
Study dates
3 Apr 2017to 1 Mar 2022
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095-6968

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227-1098

Other trials in United States

About this study

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. ..

Read the 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.

Being tested
Stepped Care for Suicide Prevention, Zero Suicide Quality Improvement
Keywords
suicide, suicide attempt, self harm, depression
Medical subject headings
Self-Injurious Behavior, Suicidal Ideation, Suicide, Suicide, Attempted, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stepped Care for Suicide PreventionBehavioural

    ZSQI plus Stepped Care for Suicide Prevention

  • Zero Suicide Quality ImprovementBehavioural

    ZSQI

Study groups in NCT03092271
Study groupRoleWhat they receive
Zero Suicide Quality Improvement (ZSQI)Active comparatorZero suicide best practices as implemented through a health system zero suicide quality improvement initiative
Receives: Behavioral: Zero Suicide Quality Improvement
Stepped Care for Suicide PreventionExperimentalZSQI plus a stepped care intervention that matches intensity of services to youth risk level.
Receives: Behavioral: Stepped Care for Suicide Prevention; Behavioral: Zero Suicide Quality Improvement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suicide Attempt Behavior

    fatal and nonfatal suicide attempts/suicide attempt behaviors

    Measured: 12-month observation period

Secondary outcomes (4)
  1. Suicide Events

    fatal and nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, active suicidal ideation

    Measured: 12-month observation period

  2. Self Harm Episodes

    suicide attempts, undetermined self-harm, and nonsuicidal self-injury

    Measured: 12-month observation period

  3. Suicidality

    Continuous measure of suicidality

    Measured: 12-month observation period

  4. Depression

    Continuous depressive symptom score

    Measured: 12-month observation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2017
  2. Study start3 Apr 2017
  3. Primary completion1 Mar 2022
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092271
Sponsor's protocol ID
112147
Other IDs
16-001594
Acronym
Step2Health
Status last verified
Nov 2022
First submitted
21 Mar 2017
Last updated
4 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Asarnow JR, Clarke GN, Firemark AJ, Bedics J, Miranda J, Zhang L, Duan N, Comulada WS. Stratified Stepped-Care for Reducing Suicide Attempts and Self-Harm in Youth: A Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2025 Dec 23:S0890-8567(25)02238-5. doi: 10.1016/j.jaac.2025.12.008. Online ahead of print.

    PubMed 41448486
  • Sheppler CR, Edelmann AC, Firemark AJ, Sugar CA, Lynch FL, Dickerson JF, Miranda JM, Clarke GN, Asarnow JR. Stepped care for suicide prevention in teens and young adults: Design and methods of a randomized controlled trial. Contemp Clin Trials. 2022 Dec;123:106959. doi: 10.1016/j.cct.2022.106959. Epub 2022 Oct 11.

    PubMed 36228984
  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

    PubMed 32368793

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