A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum
1 other identifier
interventional
1,665
1 country
5
Brief Summary
Rates of suicide have increased significantly over the past two decades, particularly among youth. Compared to the general population, autistic people are significantly more likely to think about suicide, attempt suicide, and die by suicide. Autistic individuals have identified suicide prevention as a top research priority; however, little is known about how to best help autistic youth at risk for suicide. The purpose of this study is to compare the effectiveness, feasibility, and acceptability of two suicide prevention strategies tailored for autistic individuals: the Safety Planning Intervention tailored for Autistic individuals (SPI-A) and SPI-A plus structured follow-up contacts (SPI-A+).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
August 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
February 10, 2026
February 1, 2026
5.2 years
May 25, 2022
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in suicidal ideation and behavior
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinical interview that measures suicidal ideation (range 0-5, with higher scores indicating more severe ideation) and suicidal behavior (count of total number of actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behavior). The C-SSRS will be administered at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.
Through 12 months of follow-up
Secondary Outcomes (9)
Change in mental health treatment utilization
Up to 12 months
Change in quality of life
Up to 12 months
Change in well-being
Up to 12 months
Change in skills to manage suicidal ideation
Up to 12 months
Change in access to lethal means
Up to 12 months
- +4 more secondary outcomes
Study Arms (2)
Safety Planning Intervention Tailored for Autistic Individuals
ACTIVE COMPARATORThe Safety Planning Intervention Tailored for Autistic individuals (SPI-A) is a brief collaborative intervention that results in an individually tailored plan designed to lower the short-term risk of suicide in autistic youth.
Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts
ACTIVE COMPARATORThe Safety Planning Intervention Tailored for Autistic individuals plus structured follow-up contacts (SPI-A+) is a multi-component intervention comprised of SPI-A and structured follow-up consisting of at least 2 brief contacts.
Interventions
To develop the SPI-A, clinicians work collaboratively with patients, and when indicated, their family members, to create a list of concrete coping mechanisms to be enacted leading up to or during a crisis. This list can be depicted in writing or pictorially, depending on patient preference. As part of the intervention, patients (and family members, when appropriate) also identify warning signs that signal the need to use the safety plan, as well as a detailed plan for reducing access to lethal means. SPI-A is a stand-alone intervention without a follow-up component.
SPI-A+ includes SPI-A plus a structured follow-up component. The structured follow-up component of SPI-A+ includes three elements: 1. A brief risk assessment and mood check 2. Review and, if needed, revision of SPI-A 3. Support related to outpatient mental health treatment initiation
Eligibility Criteria
You may qualify if:
- years old
You may not qualify if:
- A.2 - Enhanced EHR-Only Arm:
- Receives one of the interventions being studied (SPI-A or SPI-A+) as part of routine clinical care
- A.3 - Active PRO Arm:
- Referred to the study team by a consented clinician
- Able and willing to provide informed consent (age 18+) or assent and parental/guardian consent (age \< 18)
- Able to speak English (and, if applicable, at least one guardian also able to speak English)
- (B) Clinician Participants
- Employment as a provider serving autistic patients at one of the study sites
- Employment in a role that involves suicide risk intervention with youth patients at a participating clinic
- Able to read and speak English
- Able and willing to provide informed consent
- (C) Health System Leader Participants
- Health system or clinic leader at one of the study sites
- Employed in a role that provides administrative oversight to clinicians conducting safety plans with patients
- Able to read and speak English
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- Patient-Centered Outcomes Research Institutecollaborator
- University of Pennsylvaniacollaborator
- Nationwide Children's Hospitalcollaborator
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.collaborator
- Children's Hospital of Philadelphiacollaborator
- Seattle Children's Hospitalcollaborator
Study Sites (5)
Kennedy Krieger Institute
Baltimore, Maryland, 21113, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27510, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Roubinov, PhD
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Shari Jager-Hyman, PhD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2022
First Posted
May 31, 2022
Study Start
August 23, 2022
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Deidentified individual data that support the results will be shared after the publication of the final research report, for a period of at least 7 years.
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Deidentified individual data that support the results will be shared after the publication of the final research report, for a period of at least 7 years, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.