Suicide Prevention Interventions for Autism

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Shari Jager-Hyman, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Acute psychosis, Intoxication, Mania, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Safety Planning Intervention tailored for Autistic Individuals (SPI-A) for suicide prevention?

The Autism Adapted Safety Plan (AASP), which is similar to SPI-A, is being tested for its feasibility and acceptability in autistic adults, indicating a focus on tailoring safety plans for this group. Additionally, clinicians report using safety planning as a suicide prevention strategy across different groups, suggesting its general applicability. ^{1 2 3 4 5}

Is the Safety Planning Intervention for Autistic Individuals safe for humans?

The research does not provide specific safety data for the Safety Planning Intervention tailored for autistic individuals, but it is based on widely used safety plans in suicide prevention, which are generally considered safe. ^{1 2 3 6 7}

How is the Safety Planning Intervention tailored for Autistic Individuals different from other treatments for suicide prevention?

This treatment is unique because it is specifically designed for autistic individuals, addressing their specific needs and challenges, unlike general safety plans which are not tailored for autism. It includes structured follow-up contacts to ensure ongoing support, which is not typically part of standard safety planning interventions. ^{1 3 8 9 10}

Research Team

Danielle Roubinov, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Shari Jager-Hyman, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

You can speak and understand English.

I'm sorry, but it seems like the criterion you provided is incomplete. Can you please provide more information?

I am over 18 and can consent, or if under 18, my parents can consent for me.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Safety Planning Intervention tailored for Autistic individuals (SPI-A) or SPI-A plus structured follow-up contacts (SPI-A+)

6 weeks

At least 2 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in suicidal ideation, behavior, and other mental health outcomes

12 months

Follow-up assessments at 1, 6, and 12 months

Treatment Details

Interventions

• Safety Planning Intervention tailored for Autistic Individuals (Behavioral Intervention)
• Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts (Behavioral Intervention)

Trial Overview 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+).

Participant Groups

Group I: Safety Planning Intervention Tailored for Autistic Individuals Active Control 1 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 Contacts Active Control 1 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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Dr. Jeff Sperring

Seattle Children's Hospital

Chief Executive Officer since 2015

MD from Indiana University School of Medicine

Dr. Jeff Ojemann

Seattle Children's Hospital

Chief Medical Officer since 2022

MD from Washington University in St. Louis

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Catherine Krawczeski

Nationwide Children's Hospital

Chief Medical Officer

MD

Timothy C. Robinson

Nationwide Children's Hospital

Chief Executive Officer since 2019

BSc in Psychology and Business Administration from Indiana University

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborator

Trials

93

Recruited

25,200+

Dr. Bradley L. Schlaggar

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Chief Executive Officer since 2018

MD/PhD from Washington University in St. Louis

Dr. Ali Fatemi

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Chief Medical Officer since 2019

MD from Medical University of Vienna, MBA from Johns Hopkins Carey Business School

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Joseph W. St. Geme III

Children's Hospital of Philadelphia

Chief Medical Officer since 2021

MD, PhD, MPH

Madeline Bell

Children's Hospital of Philadelphia

Chief Executive Officer since 2015

BSc in Nursing from Villanova University, MSc in Organizational Dynamics from the University of Pennsylvania

Findings from Research

The Autism Adapted Safety Plan (AASP) is the first safety plan specifically designed for autistic adults at risk of self-harm and suicidal behavior, aiming to provide structured support during crises.

This pilot study will assess the feasibility and acceptability of the AASP among 90 participants, focusing on their experiences and the effectiveness of recruitment methods, which could inform larger future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapted suicide safety plans to address self-harm, suicidal ideation, and suicide behaviours in autistic adults: protocol for a pilot randomised controlled trial. Rodgers, J., Goodwin, J., Nielsen, E., et al.[2023]

The study developed a new assessment tool called the Risk Assessment Checklist for Self-Injury in Autism-Medical (RASCA-M) to evaluate medical risk factors associated with self-injurious behavior in non-verbal children with autism spectrum disorder (ASD).

Preliminary validation of the RASCA-M showed promising results in terms of content validity, criterion-related validity, and interobserver agreement, indicating it could effectively identify underlying medical issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Development and Testing of the Risk Assessment Checklist for Self-Injury in Autism-Medical (RACSA-M). Alberts, LB., Kettering, TL.[2022]

Clinicians feel more confident in screening for suicide risk in non-autistic clients compared to autistic clients, indicating a potential gap in training or resources for assessing suicidal risk in autistic individuals.

While clinicians use Safety Planning, an evidence-based suicide prevention strategy, at similar rates for both autistic and non-autistic clients, they find it more acceptable for non-autistic clients, suggesting a need for improved acceptance and implementation of these strategies for autistic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Health Clinicians' Screening and Intervention Practices to Reduce Suicide Risk in Autistic Adolescents and Adults. Jager-Hyman, S., Maddox, BB., Crabbe, SR., et al.[2020]

The case study highlights that a 17-year-old male with autism spectrum disorder (ASD) attempted suicide, indicating a potentially higher risk for suicidal behaviors in individuals with ASD than previously understood.

The report emphasizes the importance of understanding the unique characteristics of suicidal behaviors in adolescents with ASD and outlines strategies for preventing future suicide attempts, although specific prevention methods are not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attempted suicide of an adolescent with autism spectrum disorder. Mikami, K., Onishi, Y., Matsumoto, H.[2014]

A systematic review identified only 30 relevant studies out of 818 titles, highlighting a significant gap in research on treatment outcomes for older adolescents and adults with autism spectrum disorders (ASDs).

The review found that most studies used non-standardized assessments and lacked valid measures specifically designed for adults with ASDs, which limits the effectiveness of treatment evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures in intervention trials for adults with autism spectrum disorders; a systematic review of assessments of core autism features and associated emotional and behavioural problems. Brugha, TS., Doos, L., Tempier, A., et al.[2021]

Children with autism spectrum disorder (ASD) initially showed a 12% higher risk of injury compared to those without ASD, but this risk decreased to lower than that of non-ASD children after adjusting for demographic factors and co-occurring conditions.

The study suggests that co-occurring conditions, such as seizures and depression, may contribute to the increased injury risk in children with ASD, indicating that addressing these conditions could help reduce injury rates and improve overall safety for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injuries among children with autism spectrum disorder. Jain, A., Spencer, D., Yang, W., et al.[2019]

An 11-year-old girl with Autism Spectrum Disorder (ASD) and adjustment disorder was successfully treated after a suicide attempt, highlighting the importance of addressing both environmental triggers and personal relationships in her recovery.

The treatment focused on reducing risk factors and enhancing protective factors, leading to a complete absence of suicidal ideation or re-attempts during the course of her care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide Leap of an 11-Year-Old Girl with Autism Spectrum Disorder. Takahashi, Y., Mikami, K., Akama, F., et al.[2020]

Over 90% of adolescents recently hospitalized for suicide risk reported having access to their safety plans after discharge, indicating high retention and potential for use during critical periods.

While safety plan use and suicidal ideation both declined over time, the relationship between them varied by sex: girls showed a correlation in changes, while boys' safety plan use decreased regardless of their suicidal ideation changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety plan use in the daily lives of adolescents after psychiatric hospitalization. May, AM., Al-Dajani, N., Ballard, ED., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Adapted suicide safety plans to address self-harm, suicidal ideation, and suicide behaviours in autistic adults: protocol for a pilot randomised controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Preliminary Development and Testing of the Risk Assessment Checklist for Self-Injury in Autism-Medical (RACSA-M). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mental Health Clinicians' Screening and Intervention Practices to Reduce Suicide Risk in Autistic Adolescents and Adults. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Attempted suicide of an adolescent with autism spectrum disorder. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Outcome measures in intervention trials for adults with autism spectrum disorders; a systematic review of assessments of core autism features and associated emotional and behavioural problems. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Injuries among children with autism spectrum disorder. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Suicide Leap of an 11-Year-Old Girl with Autism Spectrum Disorder. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Safety plan use in the daily lives of adolescents after psychiatric hospitalization. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Safety planning-type interventions for suicide prevention: meta-analysis. [2022]

10. Israel pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. [2022]