Suicidal IdeationNCT05398250
A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum
A study testing Safety Planning Intervention tailored for Autistic Individuals and Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts in people with Suicidal Ideation and Suicidal and Self-injurious Behavior, run by University of North Carolina, Chapel Hill at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Suicidal Ideation, Suicidal and Self-injurious Behavior, Suicide
- What is being tested?
- Safety Planning Intervention tailored for Autistic Individuals and Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,665 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Aug 2022to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12-24 years old
- Scheduled for a clinical visit with a consented clinician Exclusion criteria: None
- A.2 - Enhanced EHR-Only Arm:
- 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
Show all 21Show fewer
- A.3 - Active PRO Arm:
- 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)
- Clinician Participants
- 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
- 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
Who cannot join
- Health System Leader Participants
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Kennedy Krieger Institute
Baltimore, Maryland, 21113
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27510
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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+).
Read the detailed description
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.
- "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. Participation is limited to EHR review and abstraction to evaluate outcomes related to the SPI-A and SPI-A+ interventions. Participants will not have contact with the study team.
- "Active Patient-Reported Outcomes (PRO)" Arm: Population: Individuals meeting the criteria for the "Enhanced EHR-Only" arm who are referred by a participating clinician to the study team and provide informed con/assent to participate in survey and interview data collection constitute this arm.
Participation consists of medical records review and abstraction, as well as survey and interview data collection. Please note that enrollment into this arm concluded 9/1/2025.
Aims
This study includes three aims:
Aim 1: Among autistic youth (age 12-24) at risk for suicide, compare the effectiveness of SPI-A vs. SPI-A+. The primary outcomes of interest are suicidal ideation (SI) and suicidal behavior (SB), as derived from electronic health records (EHR) and patient reported outcomes (PRO) data. Secondary patient-centered outcomes are mental health treatment initiation and engagement (EHR and PRO), use of acute care services for suicidality (EHR and PRO), quality of life (PRO), well-being (PRO), skills to manage SI (PRO), access to lethal means (PRO), and safety plan use (PRO).
Aim 2: Compare implementation outcomes of acceptability and feasibility for the two interventions from the perspectives of patients, clinicians, and health system administrators.
Aim 3: Explore patient characteristics that may moderate the relationship between intervention and SI and SB.
- Conditions
- Suicidal Ideation, Suicidal and Self-injurious Behavior, Suicide, Autism Spectrum Disorder
- Being tested
- Safety Planning Intervention tailored for Autistic Individuals, Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts
- Keywords
- Suicide Prevention, Autism Spectrum Disorder, Safety Planning Intervention
- Medical subject headings
- Suicidal Ideation, Self-Injurious Behavior, Suicide, Autism Spectrum Disorder, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Planning Intervention tailored for Autistic IndividualsBehavioural
Also called SPI-A
To develop the SPI-A, clinicians work collaboratively with patients, and when indicated, their family members, to create a list of concrete coping mechanisms to be enacted leading up to or during a crisis. This list can be depicted in writing or pictorially, depending on patient preference. As part of the intervention, patients (and family members, when appropriate) also identify warning signs that signal the need to use the safety plan, as well as a detailed plan for reducing access to lethal means. SPI-A is a stand-alone intervention without a follow-up component.
Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up ContactsBehavioural
Also called SPI-A+
SPI-A+ includes SPI-A plus a structured follow-up component. The structured follow-up component of SPI-A+ includes three elements:
- A brief risk assessment and mood check
- Review and, if needed, revision of SPI-A
- Support related to outpatient mental health treatment initiation
| Study group | Role | What they receive |
|---|---|---|
| Safety Planning Intervention Tailored for Autistic Individuals | Active comparator | 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. Receives: Behavioral: Safety Planning Intervention tailored for Autistic Individuals |
| Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts | Active comparator | 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. Receives: Behavioral: Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in suicidal ideation and behavior
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.
Measured: Through 12 months of follow-up
Secondary outcomes (9)
Change in mental health treatment utilization
The Service Assessment for Children and Adolescents (SACA) is an interview designed to gather information on the patient participants' use of mental health services, including residential (e.g., hospital), outpatient (e.g., outpatient mental health clinic), and school (e.g., counseling) services. The SACA will be administered at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.
Measured: Up to 12 months
Change in quality of life
The Patient-Reported Outcomes Measurement Information System (PROMIS) Autism Battery - Lifespan (PAB-L) is a subset of PROMIS measures that has been validated for assessment of quality of life among autistic individuals. The PAB-L youth self-report includes four domains: Subjective Well-being, Relationships, Emotional Distress, and Health. Items are rated on a 1-5 scale, with higher scores indicating a greater presence of the measured construct. Patient participants will complete the PAB-L at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.
Measured: Up to 12 months
Change in well-being
Well-being will be measured with the Outcome Rating Scale (ORS), a 4-item visual analog scale assessing functioning in individual, interpersonal, social, and overall functioning over the past week. Item scores range from 0-10, with higher scores indicating better functioning. Patient participants will complete the ORS at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.
Measured: Up to 12 months
Change in skills to manage suicidal ideation
The Suicide-Related Coping Scale (SRCS) assesses knowledge of and confidence in using coping strategies and supports to manage suicidal thoughts and urges. The SRCS items are rated on a 5-point scale ("strongly disagree" to "strongly agree"). Higher scores indicate greater coping skills to manage suicidal crises. Patient participants will complete the SRCS at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.
Measured: Up to 12 months
Change in access to lethal means
The patient participants will answer the three access to lethal means questions from the Adapted Behavioral Risk Factor Surveillance System Survey (BRFSS), selected from the PhenX Toolkit, at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up. These questions capture whether firearms are present in the home and, if so, how they are stored (e.g., loaded and unlocked).
Measured: Up to 12 months
Change in safety plan use
The Brief Safety Plan Use Scale (BSPUS) will be used to assess the extent to which patient participants have utilized their safety plans since the prior assessment timepoint (e.g., "How many times did you use the safety plan since last meeting?" "Where have you been keeping the safety plan?"). Patient participants will complete the BSPUS at 1-month follow-up, 6-month follow-up, and 12-month follow-up.
Measured: Up to 12 months
Change in acute care services for suicidality
The Service Assessment for Children and Adolescents (SACA) will be used to assess patient participants' acute care services for suicidal thoughts and behaviors. The SACA will be administered at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.
Measured: Up to 12 months
Intervention acceptability
Patient, clinician, and health system leader participants will complete the Acceptability of Intervention Measure (AIM), a widely used four-item measure that can be administered to a wide range of stakeholders to determine the extent to which they believe an intervention is acceptable. Items are rated from 1-5, with higher scores indicating greater acceptability. Patient participants will complete the AIM at the 1-month follow-up timepoint. Clinician and health system leader participants will complete the AIM in Year 1 and Year 4 of the study.
Measured: Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years
Intervention feasibility
Patient, clinician, and health system leader participants will complete the Feasibility of Intervention Measure (FIM), a widely used four-item measure that can be administered to a wide range of stakeholders to determine the extent to which they believe an intervention is feasible. Items are rated from 1-5, with higher scores indicating greater feasibility. Patient participants will complete the FIM at the 1-month follow-up timepoint. Clinician and health system leader participants will complete the FIM in Year 1 and Year 4 of the study.
Measured: Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start23 Aug 2022
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,665 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Pennsylvania, Nationwide Children's Hospital, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Children's Hospital of Philadelphia, Seattle Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Danielle Roubinov, PhD, Principal investigator, University of North Carolina, Chapel HillShari Jager-Hyman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398250
- Sponsor's protocol ID
- 21-2110
- Status last verified
- Feb 2026
- First submitted
- 25 May 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that support the results will be shared after the publication of the final research report, for a period of at least 7 years, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum
- ClinicalTrials.gov ID
- NCT05398250
- Acronym / sponsor ID
- 21-2110
- Conditions
- Suicidal Ideation, Suicidal and Self-injurious Behavior, Suicide, Autism Spectrum Disorder
- Keywords
- Suicide Prevention, Autism Spectrum Disorder, Safety Planning Intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,665 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Pennsylvania, Nationwide Children's Hospital, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Children's Hospital of Philadelphia, Seattle Children's Hospital
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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+).
Detailed description
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.
- "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. Participation is limited to EHR review and abstraction to evaluate outcomes related to the SPI-A and SPI-A+ interventions. Participants will not have contact with the study team.
- "Active Patient-Reported Outcomes (PRO)" Arm: Population: Individuals meeting the criteria for the "Enhanced EHR-Only" arm who are referred by a participating clinician to the study team and provide informed con/assent to participate in survey and interview data collection constitute this arm.
Participation consists of medical records review and abstraction, as well as survey and interview data collection. Please note that enrollment into this arm concluded 9/1/2025.
Aims
This study includes three aims:
Aim 1: Among autistic youth (age 12-24) at risk for suicide, compare the effectiveness of SPI-A vs. SPI-A+. The primary outcomes of interest are suicidal ideation (SI) and suicidal behavior (SB), as derived from electronic health records (EHR) and patient reported outcomes (PRO) data. Secondary patient-centered outcomes are mental health treatment initiation and engagement (EHR and PRO), use of acute care services for suicidality (EHR and PRO), quality of life (PRO), well-being (PRO), skills to manage SI (PRO), access to lethal means (PRO), and safety plan use (PRO).
Aim 2: Compare implementation outcomes of acceptability and feasibility for the two interventions from the perspectives of patients, clinicians, and health system administrators.
Aim 3: Explore patient characteristics that may moderate the relationship between intervention and SI and SB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Planning Intervention Tailored for Autistic Individuals | Active comparator | Behavioral: Safety Planning Intervention tailored for Autistic IndividualsThe 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. |
| Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts | Active comparator | Behavioral: Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up ContactsThe 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 may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 12-24 years old
- Scheduled for a clinical visit with a consented clinician Exclusion criteria: None
- 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
Key exclusion criteria (1 listed)
- Health System Leader Participants
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 |
|---|---|---|
| Safety Planning Intervention tailored for Autistic IndividualsAlso: SPI-ATo develop the SPI-A, clinicians work collaboratively with patients, and when indicated, their family members, to create a list of concrete coping mechanisms to be enacted leading up to or during a crisis. This list can be depicted in writing or pictorially, depending on patient preference. As part of the intervention, patients (and family members, when appropriate) also identify warning signs that signal the need to use the safety plan, as well as a detailed plan for reducing access to lethal means. SPI-A is a stand-alone intervention without a follow-up component. | Behavioural | Safety Planning Intervention Tailored for Autistic Individuals |
| Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up ContactsAlso: SPI-A+SPI-A+ includes SPI-A plus a structured follow-up component. The structured follow-up component of SPI-A+ includes three elements: 1. A brief risk assessment and mood check 2. Review and, if needed, revision of SPI-A 3. Support related to outpatient mental health treatment initiation | Behavioural | Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts |
Primary outcome
Change in suicidal ideation and behavior
Time frame: 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.
9 secondary outcomes
Change in mental health treatment utilization
Time frame: Up to 12 months
Change in quality of life
Time frame: Up to 12 months
Change in well-being
Time frame: Up to 12 months
Change in skills to manage suicidal ideation
Time frame: Up to 12 months
Change in access to lethal means
Time frame: Up to 12 months
Change in safety plan use
Time frame: Up to 12 months
Change in acute care services for suicidality
Time frame: Up to 12 months
Intervention acceptability
Time frame: Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years
Intervention feasibility
Time frame: Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that support the results will be shared after the publication of the final research report, for a period of at least 7 years, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Danielle Roubinov, PhD principal investigator
University of North Carolina, Chapel Hill
Shari Jager-Hyman, PhD principal investigator
University of Pennsylvania
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Planning Intervention tailored for Autistic Individuals and Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts in people with Suicidal Ideation and Suicidal and Self-injurious Behavior, run by University of North Carolina, Chapel Hill at 5 sites 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 21 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in suicidal ideation and behavior (time frame: Through 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.