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

University of North Carolina (UNC)

Status: Enrolling

Conditions: Suicidal Ideation; Autism Spectrum Disorder; Suicidal and Self-injurious Behavior; Suicide

Treatments: Behavioral: Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts; Behavioral: Safety Planning Intervention tailored for Autistic Individuals

Study type: Interventional

Funder types: Other

Identifiers

NCT05398250

21-2110

Details and patient eligibility

About

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+).

Full description

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). 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.

Enrollment: 1,665 estimated patients

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Participants

Inclusion Criteria:

• 12-24 years old
• 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

Exclusion Criteria:

• Altered mental status that precludes ability to provide informed assent or consent (acute psychosis, intoxication, or mania)

Clinician Participants

Inclusion Criteria:

• 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

Exclusion Criteria:

• There are no exclusion criteria for the clinician participants

Health System Leader Participants

Inclusion Criteria:

• 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:

• There are no exclusion criteria for the health system leader participants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,665 participants in 2 patient groups

Safety Planning Intervention Tailored for Autistic Individuals

Active Comparator group

Description:

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.

Treatment:

Behavioral: Safety Planning Intervention tailored for Autistic Individuals

Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts

Active Comparator group

Description:

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.

Treatment:

Behavioral: Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts