What side effects are associated with this type of intervention?

The Safety Planning Intervention tailored for Autistic individuals (SPI-A) focuses on creating a personalized safety plan to manage suicidal thoughts and behaviors. Common side effects for similar interventions, which often include cognitive-behavioral therapy (CBT) and other psychosocial strategies, are generally minimal but can include temporary increases in distress or anxiety as individuals confront and work through difficult emotions. These interventions are typically well-tolerated, with the primary goal being to provide immediate coping strategies and reduce the risk of suicide.

What prior FDA approvals exist?

The FDA has approved various pharmacological treatments for managing suicidal thoughts, particularly in the context of depression and other mental health disorders. Selective serotonin reuptake inhibitors (SSRIs) are commonly used and have been studied for their effects on pediatric depression and suicidality. Additionally, the FDA has issued warnings about increased suicidal thinking with certain medications, such as atomoxetine. However, there are no specific FDA approvals mentioned for non-pharmacological interventions like the Safety Planning Intervention tailored for Autistic individuals (SPI-A), which focuses on creating personalized safety plans to manage suicidal thoughts and behaviors.

What other types of research exist?

A promising novel alternative to SPI-A for managing suicidal thoughts in autistic individuals is the Safety Planning Intervention tailored for Autistic individuals plus structured follow-up contacts (SPI-A+). This approach not only includes creating a personalized safety plan but also incorporates regular follow-up contacts to provide ongoing support and monitoring, which may enhance its effectiveness and acceptability.

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Suicide Prevention Interventions for Autism

N/A

Recruiting

Led By Shari Jager-Hyman, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

15-24 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patient participants: 1-month follow-up; clinician and health system leader participants: up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two methods to prevent suicide in autistic youth aged 12-24. One method involves creating a personalized safety plan, while the other adds ongoing support through periodic check-ins. The safety plan helps individuals recognize warning signs and use coping strategies, and the check-ins provide continuous support.

Who is the study for?

This trial is for young people aged 15-24 with autism who have had suicidal thoughts or behaviors. They must speak English and have received a safety plan tailored for autistic youth during a clinical visit. Those over 18 can consent themselves, while those under need parental consent.

What is being tested?

The study compares two suicide prevention strategies specifically designed for autistic individuals: one is the Safety Planning Intervention (SPI-A), and the other adds structured follow-up contacts to SPI-A (SPI-A+).

What are the potential side effects?

Since this trial involves non-medical interventions focused on planning and follow-ups, there are no direct medical side effects; however, discussing sensitive topics like self-harm may cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 15 and 24 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patient participants: 1-month follow-up; clinician and health system leader participants: up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patient participants: 1-month follow-up; clinician and health system leader participants: up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and patient participants: 1-month follow-up; clinician and health system leader participants: up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feeling suicidal (finding)

Secondary study objectives

Change in access to lethal means

Change in acute care services for suicidality

Therapeutic procedure

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Safety Planning Intervention Tailored for Autistic IndividualsActive Control1 Intervention

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.

Group II: Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up ContactsActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Safety Planning Intervention tailored for Autistic individuals (SPI-A) involves creating a personalized safety plan that includes identifying warning signs, employing internal coping strategies, utilizing social contacts for distraction, reaching out to family members or friends for support, contacting mental health professionals, and reducing access to lethal means. These mechanisms are crucial for patients with suicidal thoughts as they provide structured, immediate steps to manage crises, enhance coping skills, and ensure access to support networks, thereby reducing the risk of suicide attempts and improving overall safety.

Effectiveness of collaborative care in reducing suicidal ideation: An individual participant data meta-analysis.