AdolescentsNCT02830334
Use of the Ask Suicide-Screening Questions (ASQ) in Pediatric Outpatient Settings
An observational study of Adolescents and Children, run by National Institute of Mental Health (NIMH) at 2 sites in United States.
Trial summary
Background: Doctors and nurses who work in non-mental health settings need ways to know when patients are at risk. Researchers created the Ask Suicide-Screening Questions (ASQ) to be used in an emergency department for children. This is a 4-item suicide risk screening tool. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adolescents, Children
- How many people
- 525 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jul 2016to 22 Apr 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient in the Adolescent/Young Adult Medicine Program.
- English-speaking
- Aged 10-21 years, inclusive.
- If 18 or older, can supply consent.
- If under 18, has a parent or legal guardian who is available for informed consent (written/verbal).
Who cannot join
- Has a severe developmental or cognitive delay.
- Has a severe communication disorder such that the patient cannot comprehend questions or communicate answers.
- Has a severe illness that prevents adequate communication.
- Parents/guardians and/or patients are non-English speaking.
- Patients under 18 years old are not with a parent/legal guardian who can provide written consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Childrens Hospital, Boston
Boston, Massachusetts, 02115
The Childrens Mercy Hospital
Kansas City, Missouri
About this study
Background:
Doctors and nurses who work in non-mental health settings need ways to know when patients are at risk. Researchers created the Ask Suicide-Screening Questions (ASQ) to be used in an emergency department for children. This is a 4-item suicide risk screening tool. We wanted to see if this is also a good tool to use in the outpatient setting. Two studies are being done to test it at hospitals. This study is for researchers to analyze the data from those two studies.
Read more
Objectives:
To combine and analyze data from two studies to see how well the ASQ can detect suicide risk in pediatric outpatient clinics.
Eligibility:
No people are enrolled in this study.
Design:
Participants in the two non-NIH studies will give consent for their data to be shared.
The data will be confidential and secure. They will have no personal information attached to them.
Researchers will get the data and analyze them.
Read the detailed description
This protocol is designed to combine and analyze data from two separate independent studies conducted at non-NIH sites-Boston Children s Hospital (BCH) and Kansas City Mercy Children s Hospital (KC). Both sites have protocols and consents reviewed by the IRBs at their respective institutions, and data collection is underway; NIMH will coordinate and oversee data analysis from these studies. A protocol to establish NIH s role in the studies and IRB review will enhance the acceptance of the research findings for publication in scientific and medical journals.
Physicians and nurses working in non-mental health settings require tools to guide them in recognizing patients at risk. While screening children and adolescents is emerging as a priority of the Joint Commission, there are currently no suicide screening instruments designed specifically for assessing suicide risk in a pediatric outpatient medical setting. Recently, our study team developed the Ask Suicide-Screening Questions (ASQ), a 4-item suicide risk screening instrument with excellent sensitivity, specificity, and negative predictive value for use in pediatric emergency departments (Protocol 08-M-N070). However, use of the ASQ in an outpatient medical setting has not been tested. The aim of the studies at BCH and KC is to determine the utility of the ASQ among youth in outpatient primary and specialty care clinics (e.g., endocrine, sports medicine, orthopedic). While most outpatients will not be at imminent risk for suicide, we hypothesize that the ASQ will capture a number of patients who screen positive and are not only at risk for suicidal behavior in the future, but are also experiencing significant emotional distress and therefore warrant further psychiatric evaluation and follow-up treatment. Data from BCH and KC will be analyzed under this protocol from a total sample size of 580. Two measures of suicide risk (the ASQ and the Suicidal Ideation Questionnaire) and a depression screen (the Patient Health Questionnaire - Adolescent version), are administered to all eligible patients aged 10-21 years. The ultimate goal is to provide non-mental health clinicians with a brief, accurate assessment tool for detecting risk of suicide in pediatric medical outpatients and in turn, connecting those in need with mental health services.
- Conditions
- Adolescents, Children
- Keywords
- Suicide, Youth Suicide
- Medical subject headings
- Suicide
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures include frequencies of positive responses to all ASQ and SIQ items.
Measured: Ongoing
Secondary outcomes (1)
Responses to demographic survey items will allow us to describe if the primary outcome measure varies by race, gender, education level, and other demographic variables. A depression screen and a brief questionnaire to assess parent opinion will...
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start9 Jul 2016
- Primary completion10 May 2018
- Study completion22 Apr 2020
Why it stopped: this study was determined by IRB not to be humans subjects research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentsStudies 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
- Prospective
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa M Horowitz, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830334
- Sponsor's protocol ID
- 999916130
- Other IDs
- 16-M-N130
- Status last verified
- Apr 2020
- First submitted
- 9 Jul 2016
- Last updated
- 28 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Ask Suicide-Screening Questions (ASQ) in Pediatric Outpatient Settings
- ClinicalTrials.gov ID
- NCT02830334
- Acronym / sponsor ID
- 999916130
- Conditions
- Adolescents, Children
- Keywords
- Suicide, Youth Suicide
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: this study was determined by IRB not to be humans subjects research
- Enrolment
- 525 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 9 Jul 2016 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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:
Doctors and nurses who work in non-mental health settings need ways to know when patients are at risk. Researchers created the Ask Suicide-Screening Questions (ASQ) to be used in an emergency department for children. This is a 4-item suicide risk screening tool. We wanted to see if this is also a good tool to use in the outpatient setting. Two studies are being done to test it at hospitals. This study is for researchers to analyze the data from those two studies.
Objectives:
To combine and analyze data from two studies to see how well the ASQ can detect suicide risk in pediatric outpatient clinics.
Eligibility:
No people are enrolled in this study.
Design:
Participants in the two non-NIH studies will give consent for their data to be shared.
The data will be confidential and secure. They will have no personal information attached to them.
Researchers will get the data and analyze them.
Detailed description
This protocol is designed to combine and analyze data from two separate independent studies conducted at non-NIH sites-Boston Children s Hospital (BCH) and Kansas City Mercy Children s Hospital (KC). Both sites have protocols and consents reviewed by the IRBs at their respective institutions, and data collection is underway; NIMH will coordinate and oversee data analysis from these studies. A protocol to establish NIH s role in the studies and IRB review will enhance the acceptance of the research findings for publication in scientific and medical journals.
Physicians and nurses working in non-mental health settings require tools to guide them in recognizing patients at risk. While screening children and adolescents is emerging as a priority of the Joint Commission, there are currently no suicide screening instruments designed specifically for assessing suicide risk in a pediatric outpatient medical setting. Recently, our study team developed the Ask Suicide-Screening Questions (ASQ), a 4-item suicide risk screening instrument with excellent sensitivity, specificity, and negative predictive value for use in pediatric emergency departments (Protocol 08-M-N070). However, use of the ASQ in an outpatient medical setting has not been tested. The aim of the studies at BCH and KC is to determine the utility of the ASQ among youth in outpatient primary and specialty care clinics (e.g., endocrine, sports medicine, orthopedic). While most outpatients will not be at imminent risk for suicide, we hypothesize that the ASQ will capture a number of patients who screen positive and are not only at risk for suicidal behavior in the future, but are also experiencing significant emotional distress and therefore warrant further psychiatric evaluation and follow-up treatment. Data from BCH and KC will be analyzed under this protocol from a total sample size of 580. Two measures of suicide risk (the ASQ and the Suicidal Ideation Questionnaire) and a depression screen (the Patient Health Questionnaire - Adolescent version), are administered to all eligible patients aged 10-21 years. The ultimate goal is to provide non-mental health clinicians with a brief, accurate assessment tool for detecting risk of suicide in pediatric medical outpatients and in turn, connecting those in need with mental health services.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient in the Adolescent/Young Adult Medicine Program.
- English-speaking
- Aged 10-21 years, inclusive.
- If 18 or older, can supply consent.
- If under 18, has a parent or legal guardian who is available for informed consent (written/verbal).
Key exclusion criteria (5 listed)
- Has a severe developmental or cognitive delay.
- Has a severe communication disorder such that the patient cannot comprehend questions or communicate answers.
- Has a severe illness that prevents adequate communication.
- Parents/guardians and/or patients are non-English speaking.
- Patients under 18 years old are not with a parent/legal guardian who can provide written consent.
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
Primary outcome measures include frequencies of positive responses to all ASQ and SIQ items.
Time frame: Ongoing
1 secondary outcome
Responses to demographic survey items will allow us to describe if the primary outcome measure varies by race, gender, education level, and other demographic variables. A depression screen and a brief questionnaire to assess parent opinion will...
Time frame: Ongoing
Results and safety
The study was stopped early (reason given: this study was determined by IRB not to be humans subjects research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
Related trials for Adolescents
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
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.
Lisa M Horowitz, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescents and Children, run by National Institute of Mental Health (NIMH) at 2 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: this study was determined by IRB not to be humans subjects research). Results are not available in the source record.
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?
Primary outcome measures include frequencies of positive responses to all ASQ and SIQ items. (time frame: Ongoing). 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 28 Apr 2020.