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.
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
- Conditions the study is for
- Suicidal Behavior, Self-Harm, Deliberate, Suicidal Ideation
- What is being tested?
- Stepped Care for Suicide Prevention and Zero Suicide Quality Improvement
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Suicidal Behavior, Self-Harm, Deliberate, Suicidal Ideation, Suicide
- 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 group | Role | What they receive |
|---|---|---|
| Zero Suicide Quality Improvement (ZSQI) | Active comparator | Zero suicide best practices as implemented through a health system zero suicide quality improvement initiative Receives: Behavioral: Zero Suicide Quality Improvement |
| Stepped Care for Suicide Prevention | Experimental | ZSQI 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.
Suicide Attempt Behavior
fatal and nonfatal suicide attempts/suicide attempt behaviors
Measured: 12-month observation period
Secondary outcomes (4)
Suicide Events
fatal and nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, active suicidal ideation
Measured: 12-month observation period
Self Harm Episodes
suicide attempts, undetermined self-harm, and nonsuicidal self-injury
Measured: 12-month observation period
Suicidality
Continuous measure of suicidality
Measured: 12-month observation period
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.
- First posted27 Mar 2017
- Study start3 Apr 2017
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicidal BehaviorStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Research Institute, University of Washington
- Responsible party
- Principal investigator, Joan Asarnow, University of California, Los Angeles
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 41448486Sheppler 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 36228984Storebo 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