Suicidal IdeationNCT04317118
Ask Suicide-Screening Questions (ASQ) for Youth With Autism Spectrum and Neurodevelopmental Disorders
An observational study of Suicidal Ideation, run by National Institute of Mental Health (NIMH) at 3 sites in United States.
Trial summary
Background: Suicide is the second leading cause of death for young people ages 10-24 years. There is no gold standard for evaluating suicidal thoughts and behaviors in young people with autism spectrum disorder (ASD) or other neurodevelopmental disorders (NDD). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Suicidal Ideation
- How many people
- 278 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jul 2021to 9 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Individuals in either inpatient or outpatient behavioral health settings or research settings.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Participants must be engaged in assessment or treatment in one of the inpatient or outpatient medical health settings from one of the study site hospitals that are part of this protocol.
- Participants must be verbally fluent and have the ability to communicate verbally. This will, in part, be determined by one of the patient s clinicians or trained study staff, who will also be an associate investigator for this study and will already have routine access to information regarding the patient s verbal fluency.
- If the parent/patient expresses interest in participating in a research study, verbal fluency will be further confirmed by asking the parents if the child is verbally fluent (e.g. regularly speaks in sentences), asking the parent if their child will be able to understand and answer the study questions, and by observing the subject as they are explaining the study. The observation will entail taking a verbatim language sample if needed and discussing the decision about whether the child meets this verbal fluency criteria with a study supervisor if needed. The data collectors will be at least high school graduates and over the age of 18 and be trained in assessing fluency level through parent interview and observation. They will also be trained to understand the presentation of individuals with ASD, as well as in how to respond if the child is noncompliant or presents with suicidal thoughts and behaviors.
- Age 8 years to 17.
- English speaking child and parent; may use an Augmentative and Alternative Communication (AAC) device to assist.
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- A legal guardian must provide permission and participant must sign an assent document or provide verbal assent.
- -Children: Children and adolescents with ASD/NDD are the focus of the study due to the lack of suicide risk screening tools available for this general population. Clients who do not speak English will be excluded from the study. Unfortunately, the screening tools that will be utilized in this study are not available at this time in any other languages besides English.
- OTHER VULNERABLE POPULATIONS:
- The study sites include health clinic or psychiatric units that serve children, adolescents or adults with ASD/NDD. Currently these sites service suicidal individuals and no validated instrument with which to assess these vulnerable individuals.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- The parent or the legal guardian is unavailable/unwilling to sign consent.
- The participant will not have prisoner status, e.g. not on probation or house arrest
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kennedy Krieger Institute/Johns Hopkins University
Baltimore, Maryland, 21205
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Nationwide Children's Hospital/ Ohio State University
Columbus, Ohio, 43201
About this study
Official title: Validating the Ask Suicide-Screening Questions (ASQ) for Youth With Autism Spectrum and Neurodevelopmental Disorders
Background:
Suicide is the second leading cause of death for young people ages 10-24 years. There is no gold standard for evaluating suicidal thoughts and behaviors in young people with autism spectrum disorder (ASD) or other neurodevelopmental disorders (NDD). Also, youth with ASD/NDD are often excluded from many research studies. Because of this, researchers need more data. They want to make sure they are asking the best questions for young people in clinics such as the National Institute of Mental Health (NIMH) clinic. They want to make sure they have the best data to determine if a person is at risk for hurting or killing himself or herself.
Read more
Objective:
To develop and assess the efficacy of a suicide screening tool for people with ASD/NDD.
Eligibility:
Youth ages 8 to 17 who are engaged in assessment or treatment at the NIMH for ASD or other NDD
Design:
Participants will fill out 4 questionnaires during a 1-hour meeting with study staff. They will answer questions about how they have been feeling. They will be asked if they think about or plan to hurt or kill themselves. They will also be asked if they have ever thought about it or planned it in the past. Other questions will assess their understanding of death. Participants can take a break if needed.
Parents of the participants will be asked similar questions.
Parents will be informed if their child has current thoughts of suicide.
About 1 week after the initial assessment, parents will be contacted to fill out a follow-up questionnaire. It will take about 10 minutes to complete.
Read the detailed description
Title:
Validating the Ask Suicide-Screening Questions
(ASQ) for Youth with Autism Spectrum and Neurodevelopmental Disorders
Study Description:<TAB>
Currently, no gold standard is available for evaluating suicidal thoughts and behaviors in individuals with Autism Spectrum Disorder (ASD) or other Neurodevelopmental Disorders (NDD). Moreover, youth with ASD/NDD are often excluded from instrument validation studies. Therefore, there is a paucity of sufficiently adapted and validated clinical suicide risk assessments for use with clients with ASD/NDD.
Objectives:
Primary Objective: The main objective of this study is to develop and assess the efficacy of a suicide screening tool for individuals with ASD/NDD.
Secondary Objectives: To assess the sensitivity/specificity of the ASQ in detecting suicide risk in youth with ASD/NDD by comparing its performance to that of the gold-standard clinician s brief suicide safety assessment, and legacy measures. To test the addition/deletion of candidate items on the sensitivity and specificity of the ASQ in detecting suicide risk in youth with ASD/NDD.
Endpoints:<TAB>
Study participation ends when the study measures are completed if/when the study participant does not screen positive on any of the suicide risk measures. If suicidality is detected, they will be treated clinically for suicidal ideation/behavior according to standard clinical practice.
- Conditions
- Suicidal Ideation
- Keywords
- Suicidal Ideation, Suicide Screening, Death, Children, Adolescents
- Medical subject headings
- Suicidal Ideation, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neurodevelopmental | Individuals between 8 and 17 years old with neurodevelopmental disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide risk
A series of candidate items assessing suicide risk, depression, hopelessness, etc. will be used to assess determine participant's suicide risk.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start15 Jul 2021
- Primary completion9 Sep 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Maryland Pao, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317118
- Sponsor's protocol ID
- 200066
- Other IDs
- 20-M-0066
- Status last verified
- 4 Sep 2026
- First submitted
- 20 Mar 2020
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Horowitz LM, Thurm A, Farmer C, Mazefsky C, Lanzillo E, Bridge JA, Greenbaum R, Pao M, Siegel M; Autism and Developmental Disorders Inpatient Research Collaborative (ADDIRC). Talking About Death or Suicide: Prevalence and Clinical Correlates in Youth with Autism Spectrum Disorder in the Psychiatric Inpatient Setting. J Autism Dev Disord. 2018 Nov;48(11):3702-3710. doi: 10.1007/s10803-017-3180-7.
PubMed 28624965Horowitz LM, Bridge JA, Teach SJ, Ballard E, Klima J, Rosenstein DL, Wharff EA, Ginnis K, Cannon E, Joshi P, Pao M. Ask Suicide-Screening Questions (ASQ): a brief instrument for the pediatric emergency department. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1170-6. doi: 10.1001/archpediatrics.2012.1276.
PubMed 23027429
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Ask Suicide-Screening Questions (ASQ) for Youth With Autism Spectrum and Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT04317118
- Acronym / sponsor ID
- 200066
- Conditions
- Suicidal Ideation
- Keywords
- Suicidal Ideation, Suicide Screening, Death, Children, Adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 23 Mar 2020 (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.
Background:
Suicide is the second leading cause of death for young people ages 10-24 years. There is no gold standard for evaluating suicidal thoughts and behaviors in young people with autism spectrum disorder (ASD) or other neurodevelopmental disorders (NDD). Also, youth with ASD/NDD are often excluded from many research studies. Because of this, researchers need more data. They want to make sure they are asking the best questions for young people in clinics such as the National Institute of Mental Health (NIMH) clinic. They want to make sure they have the best data to determine if a person is at risk for hurting or killing himself or herself.
Objective:
To develop and assess the efficacy of a suicide screening tool for people with ASD/NDD.
Eligibility:
Youth ages 8 to 17 who are engaged in assessment or treatment at the NIMH for ASD or other NDD
Design:
Participants will fill out 4 questionnaires during a 1-hour meeting with study staff. They will answer questions about how they have been feeling. They will be asked if they think about or plan to hurt or kill themselves. They will also be asked if they have ever thought about it or planned it in the past. Other questions will assess their understanding of death. Participants can take a break if needed.
Parents of the participants will be asked similar questions.
Parents will be informed if their child has current thoughts of suicide.
About 1 week after the initial assessment, parents will be contacted to fill out a follow-up questionnaire. It will take about 10 minutes to complete.
Detailed description
Title:
Validating the Ask Suicide-Screening Questions
(ASQ) for Youth with Autism Spectrum and Neurodevelopmental Disorders
Study Description:<TAB>
Currently, no gold standard is available for evaluating suicidal thoughts and behaviors in individuals with Autism Spectrum Disorder (ASD) or other Neurodevelopmental Disorders (NDD). Moreover, youth with ASD/NDD are often excluded from instrument validation studies. Therefore, there is a paucity of sufficiently adapted and validated clinical suicide risk assessments for use with clients with ASD/NDD.
Objectives:
Primary Objective: The main objective of this study is to develop and assess the efficacy of a suicide screening tool for individuals with ASD/NDD.
Secondary Objectives: To assess the sensitivity/specificity of the ASQ in detecting suicide risk in youth with ASD/NDD by comparing its performance to that of the gold-standard clinician s brief suicide safety assessment, and legacy measures. To test the addition/deletion of candidate items on the sensitivity and specificity of the ASQ in detecting suicide risk in youth with ASD/NDD.
Endpoints:<TAB>
Study participation ends when the study measures are completed if/when the study participant does not screen positive on any of the suicide risk measures. If suicidality is detected, they will be treated clinically for suicidal ideation/behavior according to standard clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental | – | –Individuals between 8 and 17 years old with neurodevelopmental disorders |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Individuals in either inpatient or outpatient behavioral health settings or research settings.
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Participants must be engaged in assessment or treatment in one of the inpatient or outpatient medical health settings from one of the study site hospitals that are part of this protocol.
- Participants must be verbally fluent and have the ability to communicate verbally. This will, in part, be determined by one of the patient s clinicians or trained study staff, who will also be an associate investigator for this study and will already have routine access to information regarding the patient s verbal fluency.
- If the parent/patient expresses interest in participating in a research study, verbal fluency will be further confirmed by asking the parents if the child is verbally fluent (e.g. regularly speaks in sentences), asking the parent if their child will be able to understand and answer the study questions, and by observing the subject as they are explaining the study. The observation will entail taking a verbatim language sample if needed and discussing the decision about whether the child meets this verbal fluency criteria with a study supervisor if needed. The data collectors will be at least high school graduates and over the age of 18 and be trained in assessing fluency level through parent interview and observation. They will also be trained to understand the presentation of individuals with ASD, as well as in how to respond if the child is noncompliant or presents with suicidal thoughts and behaviors.
- Age 8 years to 17.
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- The parent or the legal guardian is unavailable/unwilling to sign consent.
- The participant will not have prisoner status, e.g. not on probation or house arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Suicide risk
Time frame: Baseline
A series of candidate items assessing suicide risk, depression, hopelessness, etc. will be used to assess determine participant's suicide risk.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 28624965Horowitz LM, Thurm A, Farmer C, Mazefsky C, Lanzillo E, Bridge JA, Greenbaum R, Pao M, Siegel M; Autism and Developmental Disorders Inpatient Research Collaborative (ADDIRC). Talking About Death or Suicide: Prevalence and Clinical Correlates in Youth with Autism Spectrum Disorder in the Psychiatric Inpatient Setting. J Autism Dev Disord. 2018 Nov;48(11):3702-3710. doi: 10.1007/s10803-017-3180-7.
- Background: PubMed 23027429Horowitz LM, Bridge JA, Teach SJ, Ballard E, Klima J, Rosenstein DL, Wharff EA, Ginnis K, Cannon E, Joshi P, Pao M. Ask Suicide-Screening Questions (ASQ): a brief instrument for the pediatric emergency department. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1170-6. doi: 10.1001/archpediatrics.2012.1276.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Maryland Pao, M.D. principal investigator
National Institute of Mental Health (NIMH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicidal Ideation, run by National Institute of Mental Health (NIMH) at 3 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 10 inclusion and 3 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Suicide risk (time frame: Baseline). 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 NCT04317118, which also lists 2 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 9 Sep 2026.