AutismNCT06552871

Participatory Research for Suicide Prevention in Autism

A study testing Forming Love around Autistic People to Prevent Suicide in people with Autism and Suicide Prevention, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this study is to pilot test a new educational intervention for organization members focused on suicide prevention for autistic people. The main questions it aims to answer are: Does participating in the intervention increase participants' knowledge, skills, and actions to support suicide prevention for… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Autism, Suicide Prevention
What is being tested?: Forming Love around Autistic People to Prevent Suicide
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 5 Sep 2024to 5 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Active member of an organization whose work impacts autistic people
Age 18+
Fluent English language to participate in virtual educational intervention

Who cannot join

No access to an internet-connected device
Unable to participate in a virtual educational intervention

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Utah
Salt Lake City, Utah, 84108

Other trials in United States

About this study

The goal of this study is to pilot test a new educational intervention for organization members focused on suicide prevention for autistic people. The main questions it aims to answer are:

Does participating in the intervention increase participants' knowledge, skills, and actions to support suicide prevention for autistic people?
What feedback do participants have to help improve the intervention?

Participants will:

engage in a four-part virtual educational intervention
answer questions via online survey before, after, and 3-months after the intervention
participate in an optional interview to provide feedback

Read the detailed description

This study will pilot test a new four-part virtual educational intervention called Forming Love around Autistic People to Prevent Suicide (FLAPS).

Participants will be active members of an organization (e.g., paid employee, volunteer, stakeholder) whose work impacts autistic people. They will participate in four virtual educational sessions led by trained facilitators.

The educational intervention will provide current research evidence and community-informed information about suicide risk and prevention, and engage participants in active discussions to expand their knowledge and skills as well as to promote action planning to support suicide prevention for autistic people in their community.

Participants will provide demographic and descriptive information and complete the Steps Toward Prevention (Autism Community Suicide Prevention) measure at three time-points (Pre-intervention, post-intervention [approximately 2 months after baseline], and 3-months after intervention). The Steps Toward Prevention (Autism Community Suicide Prevention) measure will assess participants' knowledge, skills, and actions to support suicide prevention for autistic people. They will also be provided an option to complete a short interview to provide feedback about the FLAPS intervention.

Conditions: Autism, Suicide Prevention
Being tested: Forming Love around Autistic People to Prevent Suicide
Keywords: educational intervention, pilot test
Medical subject headings: Autistic Disorder, Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Forming Love around Autistic People to Prevent SuicideBehavioural
Also called FLAPS
Four-part virtual educational intervention

Study groups in NCT06552871
Study group	Role	What they receive
FLAPS intervention	Experimental	Participants receiving FLAPS intervention Receives: Behavioral: Forming Love around Autistic People to Prevent Suicide

What is being measured

The primary outcome is the main question the study is designed to answer.

Steps Toward Prevention - Autism Community Suicide Prevention: Knowledge & Capacity
Self-report measure of knowledge, skills, and actions to support suicide prevention for autistic people. This reported data is for the Knowledge \& Capacity scale of the Steps Toward Prevention - Autism Community Suicide Prevention measure. This scale inquires about how true eight statements are for the respondent currently on a 5-point scale (Definitely not true - Definitely true). Scores are averaged across the items (1-5 possible range). Higher numbers indicate greater knowledge and capacity for suicide prevention.
Measured: Pre-intervention, post-intervention (approximately 2 months after baseline), and 3-months after intervention
Steps Toward Prevention - Autism Community Suicide Prevention: Actions
Self-report measure of knowledge, skills, and actions to support suicide prevention for autistic people. This reported data is for the Actions scale of the Steps Toward Prevention - Autism Community Suicide Prevention measure. This inquires about how often the respondent has done twelve types of actions in the past month on a 5-point scale (Never - More than once a week). Scores are averaged across the items (1-5 possible range). Higher numbers indicate greater engagement in actions for suicide prevention.
Measured: Pre-intervention, post-intervention (approximately 2 months after baseline), and 3-months after intervention

Secondary outcomes (1)

Qualitative Interview
Open-ended interview questions to understand additional outcomes that participants experienced that they attribute to the intervention.
Measured: Post intervention (approximately 2 months after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 20245 Aug 2025

First posted14 Aug 2024
Study start5 Sep 2024
Primary completion5 Aug 2025
Study completion5 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for AutismStudies of the same condition, open and under way.
More trials run by University of UtahThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Initial pre-post pilot test
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06552871
Sponsor's protocol ID: 00139671
Other IDs: K23MH123934
Status last verified: Jan 2026
First submitted: 7 Aug 2024
Last updated: 26 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kirby AV, Bakian AV, Zhang Y, Bilder DA, Keeshin BR, Coon H. A 20-year study of suicide death in a statewide autism population. Autism Res. 2019 Apr;12(4):658-666. doi: 10.1002/aur.2076. Epub 2019 Jan 21.
PubMed 30663277
Wexler L, McEachern D, DiFulvio G, Smith C, Graham LF, Dombrowski K. Creating a Community of Practice to Prevent Suicide Through Multiple Channels: Describing the Theoretical Foundations and Structured Learning of PC CARES. Int Q Community Health Educ. 2016;36(2):115-22. doi: 10.1177/0272684X16630886. Epub 2016 Feb 15.
PubMed 26880738
Wexler L, Rataj S, Ivanich J, Plavin J, Mullany A, Moto R, Kirk T, Goldwater E, Johnson R, Dombrowski K. Community mobilization for rural suicide prevention: Process, learning and behavioral outcomes from Promoting Community Conversations About Research to End Suicide (PC CARES) in Northwest Alaska. Soc Sci Med. 2019 Jul;232:398-407. doi: 10.1016/j.socscimed.2019.05.028. Epub 2019 May 23.
PubMed 31151026
Kirby AV, Siddeek Z, Duncan-Ishcomer B, Kripke-Ludwig R, Joyce A, Rodriguez K, Lee W, Murthi K, Feldman K, Atisme A, Darlington A, Wexler L, Nicolaidis C. Pilot Test of the Forming Love around Autistic people to Prevent Suicide Program. Autism Adulthood. 2026 Sep 9:10.1177/25739581261486816. doi: 10.1177/25739581261486816. Online ahead of print.
PubMed 42770169

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism

All Autism trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Participatory Research for Suicide Prevention in Autism
ClinicalTrials.gov ID: NCT06552871
Acronym / sponsor ID: 00139671
Conditions: Autism, Suicide Prevention
Keywords: educational intervention, pilot test
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 5 Sep 2024 (actual)
Primary completion: 5 Aug 2025 (actual)
Study completion: 5 Aug 2025 (actual)
First posted: 14 Aug 2024 (actual)
Results: Posted 26 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this study is to pilot test a new educational intervention for organization members focused on suicide prevention for autistic people. The main questions it aims to answer are:

Does participating in the intervention increase participants' knowledge, skills, and actions to support suicide prevention for autistic people?
What feedback do participants have to help improve the intervention?

Participants will:

engage in a four-part virtual educational intervention
answer questions via online survey before, after, and 3-months after the intervention
participate in an optional interview to provide feedback

Detailed description

This study will pilot test a new four-part virtual educational intervention called Forming Love around Autistic People to Prevent Suicide (FLAPS).

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Initial pre-post pilot test

Arm	Type	Receives
FLAPS intervention	Experimental	Behavioral: Forming Love around Autistic People to Prevent SuicideParticipants receiving FLAPS intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Active member of an organization whose work impacts autistic people
Age 18+
Fluent English language to participate in virtual educational intervention

Key exclusion criteria (2 listed)

No access to an internet-connected device
Unable to participate in a virtual educational intervention

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Forming Love around Autistic People to Prevent SuicideAlso: FLAPSFour-part virtual educational intervention	Behavioural	FLAPS intervention

Primary outcome

Steps Toward Prevention - Autism Community Suicide Prevention: Knowledge & Capacity
Time frame: Pre-intervention, post-intervention (approximately 2 months after baseline), and 3-months after intervention
Self-report measure of knowledge, skills, and actions to support suicide prevention for autistic people. This reported data is for the Knowledge \& Capacity scale of the Steps Toward Prevention - Autism Community Suicide Prevention measure. This scale inquires about how true eight statements are for the respondent currently on a 5-point scale (Definitely not true - Definitely true). Scores are averaged across the items (1-5 possible range). Higher numbers indicate greater knowledge and capacity for suicide prevention.
Steps Toward Prevention - Autism Community Suicide Prevention: Actions
Time frame: Pre-intervention, post-intervention (approximately 2 months after baseline), and 3-months after intervention
Self-report measure of knowledge, skills, and actions to support suicide prevention for autistic people. This reported data is for the Actions scale of the Steps Toward Prevention - Autism Community Suicide Prevention measure. This inquires about how often the respondent has done twelve types of actions in the past month on a 5-point scale (Never - More than once a week). Scores are averaged across the items (1-5 possible range). Higher numbers indicate greater engagement in actions for suicide prevention.

1 secondary outcome

Qualitative Interview
Time frame: Post intervention (approximately 2 months after baseline)

Results and safety

Results posted to the registry on 26 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLAPS	51	49

Primary outcome: Steps Toward Prevention - Autism Community Suicide Prevention: Knowledge & Capacity

Time frame: Pre-intervention, post-intervention (approximately 2 months after baseline), and 3-months after intervention. Mean (Standard Deviation). Unit: Scores on a 5-point scale

Measure	FLAPS n = 51
Pre-study data: Knowledge & Capacity	3.98 (0.53)
Post-study data: Knowledge & Capacity	4.54 (0.54)
Follow-up data: Knowledge & Capacity	4.52 (0.56)

FLAPS: Mixed effects GLM Coefficient: 0.35, p <0.001, Mixed Models Analysis

Primary outcome: Steps Toward Prevention - Autism Community Suicide Prevention: Actions

Time frame: Pre-intervention, post-intervention (approximately 2 months after baseline), and 3-months after intervention. Mean (Standard Deviation). Unit: Scores on a 5-point scale

Measure	FLAPS n = 50
Pre-study data: Actions	2.95 (0.93)
Post-study data: Actions	3.55 (0.83)
Follow-up data: Actions	3.53 (0.79)

FLAPS: Mixed effects GLM Coefficient: 0.38, p <0.01, Mixed Models Analysis

Population analysed: When reporting means here, we report only those who completed the measures at each time point. For the multi-level statistical analyses, we applied baseline-observation-carried-forward to have a complete analysis including all participants. Baseline data for actions is only available for N=50 because one participant did not complete this section of the baseline questionnaire prior to study start.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Not monitored. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Monitoring	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): We did not measure the long-term effects of the intervention on autistic people and their suicide risk.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30663277Kirby AV, Bakian AV, Zhang Y, Bilder DA, Keeshin BR, Coon H. A 20-year study of suicide death in a statewide autism population. Autism Res. 2019 Apr;12(4):658-666. doi: 10.1002/aur.2076. Epub 2019 Jan 21.
Background: PubMed 26880738Wexler L, McEachern D, DiFulvio G, Smith C, Graham LF, Dombrowski K. Creating a Community of Practice to Prevent Suicide Through Multiple Channels: Describing the Theoretical Foundations and Structured Learning of PC CARES. Int Q Community Health Educ. 2016;36(2):115-22. doi: 10.1177/0272684X16630886. Epub 2016 Feb 15.
Background: PubMed 31151026Wexler L, Rataj S, Ivanich J, Plavin J, Mullany A, Moto R, Kirk T, Goldwater E, Johnson R, Dombrowski K. Community mobilization for rural suicide prevention: Process, learning and behavioral outcomes from Promoting Community Conversations About Research to End Suicide (PC CARES) in Northwest Alaska. Soc Sci Med. 2019 Jul;232:398-407. doi: 10.1016/j.socscimed.2019.05.028. Epub 2019 May 23.
Derived from this study: PubMed 42770169Kirby AV, Siddeek Z, Duncan-Ishcomer B, Kripke-Ludwig R, Joyce A, Rodriguez K, Lee W, Murthi K, Feldman K, Atisme A, Darlington A, Wexler L, Nicolaidis C. Pilot Test of the Forming Love around Autistic people to Prevent Suicide Program. Autism Adulthood. 2026 Sep 9:10.1177/25739581261486816. doi: 10.1177/25739581261486816. Online ahead of print.
Individual participant dataSharing planned: No

Related trials for Autism

RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne V Kirby, PhD principal investigator

University of Utah

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Forming Love around Autistic People to Prevent Suicide in people with Autism and Suicide Prevention, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steps Toward Prevention - Autism Community Suicide Prevention: Knowledge & Capacity (time frame: Pre-intervention, post-intervention (approximately 2 months after baseline), and 3-months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06552871, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.