NCT05398250

A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,665 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 12 Years – 99 Years
• Healthy volunteers: Not accepted

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+).

Detailed description

\*\*Participants\*\* Participants are from three distinct groups: health systems leaders, clinicians, and autistic youth (patients). The autistic youth participant pool is comprised of three subgroups, described below. 1. "Basic EHR-Only" Arm: Population: All individuals 12-24yo scheduled for a clinical visit with a consented clinician during the study recruitment period qualify for this arm. The total number of subjects for this subgroup is expected to exceed 15k individuals. Participation is limited to Electronic Health Record (EHR) review only. Participants will not have contact with the study team. 2. "Enhanced EHR-Only" Arm: Population: Individuals meeting the above criteria who also receive one of the interventions of interest (SPI-A or SPI-A+) during routine clinical care. Approximately 250-400 individuals are expected to qualify for this arm. Participation is limited to EHR review and abstraction to evaluate outcomes related to the SPI-A and SPI-A+ interventions. Participants will not have contact with the study team. 3. "Active Patient-Reported Outcomes (PRO)" Arm: Population: Individuals meeting the criteria for the "Enhanced EHR-Only" arm who are referred by a participating clinician to the study team and provide informed con/assent to participate in survey and interview data collection constitute this arm. Participation consists of medical records review and abstraction, as well as survey and interview data collection. Please note that enrollment into this arm concluded 9/1/2025. \*\*Aims\*\* This study includes three aims: 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), as derived from electronic health records (EHR) and patient reported outcomes (PRO) data. Secondary patient-centered outcomes are mental health treatment initiation and engagement (EHR and PRO), use of acute care services for suicidality (EHR and PRO), quality of life (PRO), well-being (PRO), skills to manage SI (PRO), access to lethal means (PRO), and safety plan use (PRO). 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

• Suicidal Ideation
• Suicidal and Self-injurious Behavior
• Suicide
• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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

Timeline

• Start date: 2022-08-23
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2022-05-31
• Last updated: 2026-02-10

Locations

5 sites across 1 country: United States