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

Suicide Clinical Trial

— Step2Health  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092271
• Other study ID #: 112147
• Secondary ID: 16-001594
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: March 1, 2022

Study information

• Verified date: November 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 care for suicide prevention intervention for adolescents and young adults that matches treatment intensity with risk levels for suicide/self-harm. ..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Self-Harm, Deliberate
• Self-Injurious Behavior
• Suicidal Behavior
• Suicidal Ideation
• Suicide

Intervention

Behavioral:
• Stepped Care for Suicide Prevention
ZSQI plus Stepped Care for Suicide Prevention
• Zero Suicide Quality Improvement
ZSQI

Locations

Country	Name	City	State
United States	University of California Los Angeles (UCLA)	Los Angeles	California
United States	Kaiser Permanente Northwest	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Kaiser Foundation Research Institute, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicide Attempt Behavior	fatal and nonfatal suicide attempts/suicide attempt behaviors	12-month observation period
Secondary	Suicide Events	fatal and nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, active suicidal ideation	12-month observation period
Secondary	Self Harm Episodes	suicide attempts, undetermined self-harm, and nonsuicidal self-injury	12-month observation period
Secondary	Suicidality	Continuous measure of suicidality	12-month observation period
Secondary	Depression	Continuous depressive symptom score	12-month observation period