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New study tests tailored suicide prevention for autistic youth

NCT ID NCT05398250

Symptom relief Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two suicide prevention programs designed specifically for autistic youth aged 12-24. One program is a safety planning intervention (SPI-A), and the other adds follow-up contacts (SPI-A+). Researchers will track changes in suicidal thoughts and behaviors over a year to see which approach works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Safety Planning Intervention tailored for Autistic individuals (SPI-A) with or without follow-up contacts
What this could lead to
If successful, this could provide effective, tailored suicide prevention strategies for autistic youth, a group at high risk.
What could go wrong
This is a large study but still early in testing these specific adaptations. Results may not apply to all autistic youth, and the interventions may not reduce suicide rates as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,665 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

(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 Exclusion criteria: None 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

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Self-Injurious Behavior Suicidal Ideation Suicide Suicide Prevention

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder Suicidal and self-injurious behavior Suicidal ideation Suicide

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21113, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.