Clinical trial NCT05398250: A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum
Official title: A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicidal and Self-injurious Behavior
Suicide
Autism Spectrum Disorder
Keywords: Suicide Prevention
Autism Spectrum Disorder
Safety Planning Intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Pennsylvania
name: Nationwide Children's Hospital
name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Children's Hospital of Philadelphia
name: Seattle Children's Hospital
First posted: 2022-05-31
Enrollment: 1665
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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+).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in suicidal ideation and behavior
timeFrame: Through 12 months of follow-up
Secondary outcomes:
measure: Change in mental health treatment utilization
timeFrame: Up to 12 months
measure: Change in quality of life
timeFrame: Up to 12 months
measure: Change in well-being
timeFrame: Up to 12 months
measure: Change in skills to manage suicidal ideation
timeFrame: Up to 12 months
measure: Change in access to lethal means
timeFrame: Up to 12 months
measure: Change in safety plan use
timeFrame: Up to 12 months
measure: Change in acute care services for suicidality
timeFrame: Up to 12 months
measure: Intervention acceptability
timeFrame: Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years
measure: Intervention feasibility
timeFrame: Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Pennsylvania
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Danielle Roubinov, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Shari Jager-Hyman, PhD
role: PRINCIPAL_INVESTIGATOR
References: