NCT03092271

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. ..

Trial Health

87
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

March 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

4.9 years

First QC Date

March 21, 2017

Last Update Submit

November 2, 2022

Conditions

Suicidal BehaviorSelf-Harm, DeliberateSuicidal IdeationSuicide

Keywords

suicidesuicide attemptself harmdepression

Outcome Measures

Primary Outcomes (1)

  • Suicide Attempt Behavior

    fatal and nonfatal suicide attempts/suicide attempt behaviors

    12-month observation period

Secondary Outcomes (4)

  • Suicide Events

    12-month observation period

  • Self Harm Episodes

    12-month observation period

  • Suicidality

    12-month observation period

  • Depression

    12-month observation period

Study Arms (2)

Zero Suicide Quality Improvement (ZSQI)

ACTIVE COMPARATOR

Zero suicide best practices as implemented through a health system zero suicide quality improvement initiative

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.

Behavioral: Stepped Care for Suicide PreventionBehavioral: Zero Suicide Quality Improvement

Interventions

Stepped Care for Suicide PreventionBEHAVIORAL

ZSQI plus Stepped Care for Suicide Prevention

Stepped Care for Suicide Prevention
Zero Suicide Quality ImprovementBEHAVIORAL

ZSQI

Stepped Care for Suicide PreventionZero Suicide Quality Improvement (ZSQI)

Eligibility Criteria

Age12 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California Los Angeles (UCLA)

Los Angeles, California, 90095-6968, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227-1098, United States

Location

Related Publications (3)

  • 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.

    PMID: 41448486DERIVED

  • 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.

    PMID: 36228984DERIVED

  • 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.

    PMID: 32368793DERIVED

MeSH Terms

Conditions

Self-Injurious BehaviorSuicidal IdeationSuicideSuicide, AttemptedDepression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 27, 2017

Study Start

April 3, 2017

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(2)