Clinical trial NCT05304065: Youth Partners in Care for Suicide Prevention
Official title: Youth Partners in Care for Suicide Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Suicide and Self-harm
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Duke University
name: Brown University
name: University of Utah
name: Olive View-UCLA Education & Research Institute
name: RAND
name: Patient-Centered Outcomes Research Institute
First posted: 2022-03-31
Enrollment: 1600
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized comparative effectiveness trial will compare two evidence-based approaches to emergency care for youth ages 13-24 who present to the Emergency Department (ED) with suicidal ideation or behavior. Outcomes will be monitored at baseline and at 3, 6 \& 12 month follow-up assessments.

Detailed description: Rationale and Importance of Study:

Suicide is currently the second leading cause of death for U.S. youth ages 13-24, responsible for more deaths than any major illness. Youth with serious suicidal behavior or thoughts often present to the nation's Emergency Departments (EDs), particularly youth who make potentially deadly suicide attempts. Evidence is limited regarding optimal interventions for reducing the risk of fatal and nonfatal suicide attempts in these youth, and tested interventions include multiple components. One dimension along which these interventions vary is timing. Some interventions are delivered in the ED, others focus on aftercare, and others combine ED and aftercare interventions. Current evidence supports effectiveness of some interventions for reducing later suicide attempts and improving the likelihood that youth will receive mental health treatment after leaving the ED. However, evidence gaps exist regarding: 1) whether it is sufficient to focus on providing an evidence-based intervention in the ED, or whether a post-ED aftercare intervention is needed to improve youth outcomes; and 2) for which patient subgroups a combined ED and aftercare treatment may be indicated. Answering these questions is vital for guiding resource allocation, as ED care emphasizes care in the ED with limited resources for aftercare.

Study Aims:

The study addresses this evidence gap by comparing two evidence-based interventions for reducing suicide attempts and improving outcomes for youth presenting to EDs with suicidal episodes: 1) Safety-Acute(A) integrated within ED care, a crisis therapy/safety planning intervention in the ED focused on enhancing safety (previously called Family Intervention for Suicide Prevention, FISP); and 2) SAFETY-A/ED care plus the Coping Long-term with Active Suicide Program (CLASP), comprised of brief therapeutic follow-up contacts after discharge from the ED/hospital. Evidence supports benefits of both interventions individually. SAFETY-A/FISP is listed in the National Register of Evidence-Based Practices, and CLASP is being implemented in some Veterans Administration Hospitals. The first aim is to evaluate whether SAFETY-A/ED Care combined with CLASP aftercare is superior to SAFETY- A/ED Care alone for reducing the risk of suicide attempts and increasing initiation of follow-up mental health treatment. Second, the investigators examine heterogeneity of treatment effects among subgroups, hypothesizing that in this large diverse sample the strongest benefits of the combined SAFETY-A/ED Care plus CLASP intervention will be seen in youth who are from ethnic or racial minority groups, socioeconomically disadvantaged, and from rural communities. Third, the investigators aim to increase the value and relevance of the study by engaging patients, parents, family members, providers, and health and mental healthcare system stakeholders in project leadership and activities throughout the study and implement a partnered dissemination plan to enhance the potential for study findings to inform clinical practice and health care delivery.

Study Description:

The patient population includes 1,600 youth ages 13-24 presenting to EDs with suicidal ideation or behavior in 4 communities across the country selected to include a diverse population (racial, ethnic, rural vs urban, public vs private insurance): California/Los Angeles; North Carolina; Rhode Island; Utah. Youth are randomly assigned to: 1) SAFETY-A/ED Care; or 2) SAFETY-A/ED Care plus CLASP. Assessments are conducted at the start of the study and at 3, 6, and 12-month follow-ups. Primary outcomes are suicide attempts and mental health treatment initiation. Secondary outcomes are overall self-harm (including suicide attempts and non-suicidal self-harm) and treatment engagement/dose. Exploratory outcomes are: severity of youth suicidality; youth functioning and quality of life; and improvement on three problems prioritized by the youth and parent or significant other as "top problems." The investigators also examine change in identified protective and risk factors (e.g. connectedness, hopelessness, and perceived barriers to treatment). The investigators partner with diverse stakeholders, develop a Stakeholder Council, and include stakeholder partners in project leadership and activities with the goals of promoting 2-way knowledge exchange and enhancing the value of the study for improving patient care and outcomes.

Significance:

Study results will clarify whether the additional resources needed to provide brief therapeutic follow-up calls after an ED intervention leads to improved outcomes, and which patient subgroups are most likely to benefit from a treatment approach that provides therapeutic contact both during the ED visit and after discharge from the ED. This information can guide decision makers regarding how to best develop services and service systems to improve patient outcomes and achieve national suicide prevention goals, including for diverse groups to improve equity.

Eligibility criteria: Inclusion Criteria:

* age 13-24;
* past-week suicidal behavior or ideation with plan or intent

Exclusion Criteria:

* symptoms or illness that precludes informed consent or engagement in study procedures (e.g., active psychosis; drug dependence, no locator information);
* youth not fluent in English
* parent not fluent in English or Spanish.

Primary outcomes:
measure: Suicide Attempts: Primary Clinical Outcome
timeFrame: Through 12 months of follow-up
measure: Mental Health Treatment Initiation: Primary Service Use Outcome
timeFrame: Through 12 months of follow-up
Secondary outcomes:
measure: Self-Harm: Secondary Clinical Outcome
timeFrame: Through 12 months of follow-up
measure: Treatment engagement: Secondary Service Use Outcome
timeFrame: Through 12 months of follow-up
Other outcomes:
measure: Ordinal suicidality scale: Clinical
timeFrame: Through 12 months of follow-up
measure: Quality of life and functioning: Clinical
timeFrame: Change from baseline through 12 months of follow-up
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan Medical Center
state: California
city: Sylmar
country: United States
facility: Olive View UCLA Education and Research Center
state: California
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Providence
country: United States
facility: Brown University
state: Rhode Island
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of California, Los Angeles
name: Joan R Asarnow, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: David Goldston, PhD
role: PRINCIPAL_INVESTIGATOR
References: