A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,665
- 试验地点
- 5
- 主要终点
- Change in suicidal ideation and behavior
研究概览
简要总结
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+).
详细描述
**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.
- "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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(A) Patient Participants
- •Please note that that eligibility criteria differ for each distinct patient subgroup as defined below.
- •A.1 - Basic EHR-Only Arm
- •Inclusion criteria:
- •12-24 years old
- •Scheduled for a clinical visit with a consented clinician
排除标准
- •A.2 - Enhanced EHR-Only Arm:
- •Inclusion criteria:
- •Meets inclusion criteria for the Basic EHR-Only arm
- •Receives one of the interventions being studied (SPI-A or SPI-A+) as part of routine clinical care
- •Exclusion criteria: Presence of documentation that the patient declines all research participation
- •A.3 - Active PRO Arm:
- •Inclusion Criteria:
- •Meets inclusion criteria for the Enhanced EHR-Only 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)
- •Exclusion Criteria: Altered mental status that precludes ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
- •(B) 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
- •Exclusion Criteria: None
- •(C) 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
- •Exclusion Criteria: None
研究组 & 干预措施
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.
干预措施: Safety Planning Intervention tailored for Autistic Individuals (Behavioral)
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.
干预措施: Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts (Behavioral)
结局指标
主要结局
Change in suicidal ideation and behavior
时间窗: Through 12 months of follow-up
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.
次要结局
- Change in mental health treatment utilization(Up to 12 months)
- Change in quality of life(Up to 12 months)
- Intervention acceptability(Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years)
- Intervention feasibility(Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years)
- Change in well-being(Up to 12 months)
- Change in acute care services for suicidality(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)
- Change in safety plan use(Up to 12 months)