Clinical trial NCT03092271: Randomized Trial of Stepped Care for Suicide Prevention in Teens and Young Adults
Official title: Randomized Trial of Stepped Care for Suicide Prevention in Teens and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Behavior
Self-Harm, Deliberate
Suicidal Ideation
Suicide
Keywords: suicide
suicide attempt
self harm
depression
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: University of Washington
First posted: 2017-03-27
Enrollment: 301
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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. ..

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.

Eligibility 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.

Primary outcomes:
measure: Suicide Attempt Behavior
timeFrame: 12-month observation period
Secondary outcomes:
measure: Suicide Events
timeFrame: 12-month observation period
measure: Self Harm Episodes
timeFrame: 12-month observation period
measure: Suicidality
timeFrame: 12-month observation period
measure: Depression
timeFrame: 12-month observation period
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
Study officials:
References:
citation: 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.
citation: 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.