A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum
NCT ID: NCT05398250
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1665 participants
INTERVENTIONAL
2022-08-23
2026-09-30
Brief Summary
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Detailed Description
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Aim 1: Among autistic youth (age 12-24) at risk for suicide, compare the effectiveness of SPI-A vs. SPI-A+. The primary outcomes of interest are suicidal ideation (SI) and suicidal behavior (SB). Secondary patient-centered outcomes are mental health treatment initiation and engagement, quality of life, well-being, skills to manage SI, access to lethal means, safety plan use, and acute care services for suicidality.
Aim 2: Compare implementation outcomes of acceptability and feasibility for the two interventions from the perspectives of patients, clinicians, and health system administrators.
Aim 3: Explore patient characteristics that may moderate the relationship between intervention and SI and SB.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Safety Planning Intervention Tailored for Autistic Individuals
The 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
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.
Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts
The 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.
Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts
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
Interventions
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Safety Planning Intervention tailored for Autistic Individuals
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.
Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able and willing to provide informed consent (age ≥18) or assent and parental consent (age \<18)
* Able to speak English
* Have received a safety plan tailored for autistic youth during a clinical visit
* 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
* 18-99 years old
* 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
* Able and willing to provide informed consent
* 18-99 years old
Exclusion Criteria
Clinician Participants
Health System Leader Participants
12 Years
99 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Pennsylvania
OTHER
Nationwide Children's Hospital
OTHER
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
OTHER
Children's Hospital of Philadelphia
OTHER
Seattle Children's Hospital
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Danielle Roubinov, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Shari Jager-Hyman, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Kennedy Krieger Institute
Baltimore, Maryland, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-2110
Identifier Type: -
Identifier Source: org_study_id
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