Youth Partners in Care for Suicide Prevention

Suicide and Self-harm Clinical Trial

— YPIC-SP  

Official title:

Youth Partners in Care for Suicide Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304065
• Other study ID #: SP-2020C3-21078
• Status: Recruiting
• Phase: Phase 2
• Start date: October 17, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: Lucas Zullo, PhD
• Phone: 310 794-4962
• Email: lzullo[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized comparative effectiveness trial will compare two evidence-based approaches to emergency care for youth ages 15-24 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.

Description:

Rationale and Importance of Study: Suicide is currently the second leading cause of death for U.S. youth ages 15-24, 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 1,516 youth ages 15-24 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1516
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

Inclusion Criteria:

• age 15-24;
• 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.

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicide
• Suicide and Self-harm
• Suicide Prevention

Intervention

Behavioral:
• SAFETY-A within usual ED Care
SAFETY-A is a single session collaborative, strengths-based, developmentally nuanced, cognitive-behavioral intervention (CBT) to increase safety and mental health treatment initiation. The therapist works with the youth and family (or significant other, SO) separately and together to build hope and reasons for living, develop a personal safety plan, increase protective supports; and increase motivation for and linkage to treatment.
• Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts
COMB, includes SAFETY-A within usual ED care plus CLASP therapeutic and caring follow-up contacts designed to strengthen safety and treatment initiation and engagement. Core functions of CLASP include: building hope/reducing hopelessness; enhancing social/family support; strengthening problem-solving; and increasing treatment initiation and engagement.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Ronald Reagan Medical Center	Los Angeles	California
United States	Brown University	Providence	Rhode Island
United States	University of Utah	Salt Lake City	Utah
United States	Olive View UCLA Education and Research Center	Sylmar	California

Sponsors (7)

Lead Sponsor	Collaborator
University of California, Los Angeles	Brown University, Duke University, Olive View-UCLA Education & Research Institute, Patient-Centered Outcomes Research Institute, RAND, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ordinal suicidality scale: Clinical	Ranges from nonsuicidal through ideation, behavior, attempts, and deaths	Through 12 months of follow-up
Other	Quality of life and functioning: Clinical	PROMIS Global Health Questionnaire , 0-100	Change from baseline through 12 months of follow-up
Primary	Suicide Attempts: Primary Clinical Outcome	suicide attempts fatal, nonfatal, and interrupted	Through 12 months of follow-up
Primary	Mental Health Treatment Initiation: Primary Service Use Outcome	initiation of mental health treatment after discharge from ED/hospital	Through 12 months of follow-up
Secondary	Self-Harm: Secondary Clinical Outcome	Any self-harm including suicidal, nonsuicidal, and ambiguous self-harm	Through 12 months of follow-up
Secondary	Treatment engagement: Secondary Service Use Outcome	Treatment dose received	Through 12 months of follow-up

External Links

•   Study description on PCORI site