ChildrenNCT02050867
Validation of the Ask Suicide-Screening Questions (ASQ) in the Inpatient Medical Setting
An observational study of Children and Adolescents, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Children, Adolescents
- How many people
- 562 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2014to 12 Sep 2019
- 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 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All pediatric medical inpatients, aged 10 to 21 years, who are current inpatients on selected medical units at the three different sites during data collection weeks, will be approached for enrollment. Patients will be included if: 1) they are admitted as an inpatient from Sunday at 7am through Thursday 11:59pm and 2) they have a parent or legal guardian who is present to sign informed consent (for patients under 18 years of age)
Who cannot join
- Patients will be excluded if: 1) they have severe developmental delays, cognitive impairment, or communication disorder such that the patient is not able to comprehend questions or communicate their answers; 2) their illnesses are so severe that the study staff feels that they may not able to comprehend questions or communicate their answers; 3) they have primarily psychiatric disorders and are boarding ; 4) parents/guardians
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Hospital, Columbus
Columbus, Ohio, 43205-2696
About this study
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 inpatient medical population. 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 inpatient medical setting has not been tested. The aim of this study is to determine the utility of the ASQ among pediatric medical inpatients in children s hospitals. While most inpatients 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. This will be a multisite study, comprised of medically ill inpatients at three non-NIH affiliated sites (Children s National Medical Center, Boston Children s Hospital, and Nationwide Children s Hospital), with a total sample size of 600 (200 per site). We will administer several short measures of suicide risk the ASQ, the Suicidal Ideation Questionnaire, a brief depression screen, the Patients Health Questionnaire Adolescent version (PHQ-A) to all eligible inpatients aged 10-21 years. The ultimate goal of this project is to provide non-mental health clinicians with a brief, accurate assessment tool for detecting risk of suicide in pediatric medical inpatients and in turn, connecting those in need with mental health services. After validating the ASQ with pediatric medical inpatients, we will then examine the practical implications of nurses administering the ASQ as standard of care during the admission process on a pediatric medical inpatient unit. Future studies will focus on validating the ASQ in non-English speaking patients, addressing a critical gap in suicide prevention research. In addition, examining the long-term clinical impact of screening general medical patients for suicide risk with the ASQ and linking those in need with mental health services and/or other interventions will be important next steps.
Please note: This is a multi-site study that is being conducted at three non-NIH sites, all children s hospitals, two of which have already received IRB approval (Boston Children s Hospital and Children s National Medical Center) and one which is in the process of submission (Nationwide Children s Hospital). No NIH patients will be enrolled at the Clinical Center. Consent and patient data collection will take place on inpatient medical units at those three sites; data will be sent to NIMH, and stored and analyzed here.
Read the detailed description
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 inpatient medical population. 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 inpatient medical setting has not been tested. The aim of this study is to determine the utility of the ASQ among pediatric medical inpatients in children s hospitals. While most inpatients 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. This will be a multisite study, comprised of medically ill inpatients at three non-NIH affiliated sites (Children s National Medical Center, Boston Children s Hospital, and Nationwide Children s Hospital), with a total sample size of 600 (200 per site). We will administer several short measures of suicide risk the ASQ, the Suicidal Ideation Questionnaire, a brief depression screen, the Patients Health Questionnaire Adolescent version (PHQ-A) to all eligible inpatients aged 10-21 years. The ultimate goal of this project is to provide non-mental health clinicians with a brief, accurate assessment tool for detecting risk of suicide in pediatric medical inpatients and in turn, connecting those in need with mental health services. After validating the ASQ with pediatric medical inpatients, we will then examine the practical implications of nurses administering the ASQ as standard of care during the admission process on a pediatric medical inpatient unit. Future studies will focus on validating the ASQ in non-English speaking patients, addressing a critical gap in suicide prevention research. In addition, examining the long-term clinical impact of screening general medical patients for suicide risk with the ASQ and linking those in need with mental health services and/or other interventions will be important next steps.
Please note: This is a multi-site study that is being conducted at three non-NIH sites, all children s hospitals, all of which have already received IRB approval (Boston Children s Hospital, Children s National Medical Center and Nationwide Children s Hospital). The CNS IRB requires that we have an NIMH parent protocol even though no NIH patients will be enrolled at the Clinical Center. Consent and patient data collection will take place on inpatient medical units at those three sites; data will be sent to NIMH, and stored and analyzed here.
- Conditions
- Children, Adolescents
- Keywords
- Youth Suicide, 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: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study start29 Jan 2014
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies 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
- Time perspective
- Prospective
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Boston Children's Hospital, Children's National Research Institute, Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Lisa M Horowitz, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050867
- Sponsor's protocol ID
- 999914044
- Other IDs
- 14-M-N044
- Status last verified
- 12 Sep 2019
- First submitted
- 29 Jan 2014
- Last updated
- 16 Sep 2019
- Results posted
- No
Publications
Furlanetto LM, Stefanello B. Suicidal ideation in medical inpatients: psychosocial and clinical correlates. Gen Hosp Psychiatry. 2011 Nov-Dec;33(6):572-8. doi: 10.1016/j.genhosppsych.2011.08.002. Epub 2011 Sep 9.
PubMed 21908051Qin P, Webb R, Kapur N, Sorensen HT. Hospitalization for physical illness and risk of subsequent suicide: a population study. J Intern Med. 2013 Jan;273(1):48-58. doi: 10.1111/j.1365-2796.2012.02572.x. Epub 2012 Aug 12.
PubMed 22775487Christiansen E, Stenager E. Risk for attempted suicide in children and youths after contact with somatic hospitals: a Danish register based nested case-control study. J Epidemiol Community Health. 2012 Mar;66(3):247-53. doi: 10.1136/jech.2009.103887. Epub 2010 Oct 14.
PubMed 20947873Horowitz LM, Wharff EA, Mournet AM, Ross AM, McBee-Strayer S, He JP, Lanzillo EC, White E, Bergdoll E, Powell DS, Solages M, Merikangas KR, Pao M, Bridge JA. Validation and Feasibility of the ASQ Among Pediatric Medical and Surgical Inpatients. Hosp Pediatr. 2020 Sep;10(9):750-757. doi: 10.1542/hpeds.2020-0087.
PubMed 32826283Ross AM, White E, Powell D, Nelson S, Horowitz L, Wharff E. To Ask or Not to Ask? Opinions of Pediatric Medical Inpatients about Suicide Risk Screening in the Hospital. J Pediatr. 2016 Mar;170:295-300. doi: 10.1016/j.jpeds.2015.11.052. Epub 2015 Dec 24.
PubMed 26725208
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Ask Suicide-Screening Questions (ASQ) in the Inpatient Medical Setting
- ClinicalTrials.gov ID
- NCT02050867
- Acronym / sponsor ID
- 999914044
- Conditions
- Children, Adolescents
- Keywords
- Youth Suicide, Suicide
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 562 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Collaborators
- Boston Children's Hospital, Children's National Research Institute, Nationwide Children's Hospital
- Study start
- 29 Jan 2014
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 31 Jan 2014 (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.
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 inpatient medical population. 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 inpatient medical setting has not been tested. The aim of this study is to determine the utility of the ASQ among pediatric medical inpatients in children s hospitals. While most inpatients 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. This will be a multisite study, comprised of medically ill inpatients at three non-NIH affiliated sites (Children s National Medical Center, Boston Children s Hospital, and Nationwide Children s Hospital), with a total sample size of 600 (200 per site). We will administer several short measures of suicide risk the ASQ, the Suicidal Ideation Questionnaire, a brief depression screen, the Patients Health Questionnaire Adolescent version (PHQ-A) to all eligible inpatients aged 10-21 years. The ultimate goal of this project is to provide non-mental health clinicians with a brief, accurate assessment tool for detecting risk of suicide in pediatric medical inpatients and in turn, connecting those in need with mental health services. After validating the ASQ with pediatric medical inpatients, we will then examine the practical implications of nurses administering the ASQ as standard of care during the admission process on a pediatric medical inpatient unit. Future studies will focus on validating the ASQ in non-English speaking patients, addressing a critical gap in suicide prevention research. In addition, examining the long-term clinical impact of screening general medical patients for suicide risk with the ASQ and linking those in need with mental health services and/or other interventions will be important next steps.
Please note: This is a multi-site study that is being conducted at three non-NIH sites, all children s hospitals, two of which have already received IRB approval (Boston Children s Hospital and Children s National Medical Center) and one which is in the process of submission (Nationwide Children s Hospital). No NIH patients will be enrolled at the Clinical Center. Consent and patient data collection will take place on inpatient medical units at those three sites; data will be sent to NIMH, and stored and analyzed here.
Detailed description
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 inpatient medical population. 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 inpatient medical setting has not been tested. The aim of this study is to determine the utility of the ASQ among pediatric medical inpatients in children s hospitals. While most inpatients 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. This will be a multisite study, comprised of medically ill inpatients at three non-NIH affiliated sites (Children s National Medical Center, Boston Children s Hospital, and Nationwide Children s Hospital), with a total sample size of 600 (200 per site). We will administer several short measures of suicide risk the ASQ, the Suicidal Ideation Questionnaire, a brief depression screen, the Patients Health Questionnaire Adolescent version (PHQ-A) to all eligible inpatients aged 10-21 years. The ultimate goal of this project is to provide non-mental health clinicians with a brief, accurate assessment tool for detecting risk of suicide in pediatric medical inpatients and in turn, connecting those in need with mental health services. After validating the ASQ with pediatric medical inpatients, we will then examine the practical implications of nurses administering the ASQ as standard of care during the admission process on a pediatric medical inpatient unit. Future studies will focus on validating the ASQ in non-English speaking patients, addressing a critical gap in suicide prevention research. In addition, examining the long-term clinical impact of screening general medical patients for suicide risk with the ASQ and linking those in need with mental health services and/or other interventions will be important next steps.
Please note: This is a multi-site study that is being conducted at three non-NIH sites, all children s hospitals, all of which have already received IRB approval (Boston Children s Hospital, Children s National Medical Center and Nationwide Children s Hospital). The CNS IRB requires that we have an NIMH parent protocol even though no NIH patients will be enrolled at the Clinical Center. Consent and patient data collection will take place on inpatient medical units at those three sites; data will be sent to NIMH, and stored and analyzed here.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All pediatric medical inpatients, aged 10 to 21 years, who are current inpatients on selected medical units at the three different sites during data collection weeks, will be approached for enrollment. Patients will be included if: 1) they are admitted as an inpatient from Sunday at 7am through Thursday 11:59pm and 2) they have a parent or legal guardian who is present to sign informed consent (for patients under 18 years of age)
Key exclusion criteria (1 listed)
- Patients will be excluded if: 1) they have severe developmental delays, cognitive impairment, or communication disorder such that the patient is not able to comprehend questions or communicate their answers; 2) their illnesses are so severe that the study staff feels that they may not able to comprehend questions or communicate their answers; 3) they have primarily psychiatric disorders and are boarding ; 4) parents/guardians
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: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Background: PubMed 21908051Furlanetto LM, Stefanello B. Suicidal ideation in medical inpatients: psychosocial and clinical correlates. Gen Hosp Psychiatry. 2011 Nov-Dec;33(6):572-8. doi: 10.1016/j.genhosppsych.2011.08.002. Epub 2011 Sep 9.
- Background: PubMed 22775487Qin P, Webb R, Kapur N, Sorensen HT. Hospitalization for physical illness and risk of subsequent suicide: a population study. J Intern Med. 2013 Jan;273(1):48-58. doi: 10.1111/j.1365-2796.2012.02572.x. Epub 2012 Aug 12.
- Background: PubMed 20947873Christiansen E, Stenager E. Risk for attempted suicide in children and youths after contact with somatic hospitals: a Danish register based nested case-control study. J Epidemiol Community Health. 2012 Mar;66(3):247-53. doi: 10.1136/jech.2009.103887. Epub 2010 Oct 14.
- Derived from this study: PubMed 32826283Horowitz LM, Wharff EA, Mournet AM, Ross AM, McBee-Strayer S, He JP, Lanzillo EC, White E, Bergdoll E, Powell DS, Solages M, Merikangas KR, Pao M, Bridge JA. Validation and Feasibility of the ASQ Among Pediatric Medical and Surgical Inpatients. Hosp Pediatr. 2020 Sep;10(9):750-757. doi: 10.1542/hpeds.2020-0087.
- Derived from this study: PubMed 26725208Ross AM, White E, Powell D, Nelson S, Horowitz L, Wharff E. To Ask or Not to Ask? Opinions of Pediatric Medical Inpatients about Suicide Risk Screening in the Hospital. J Pediatr. 2016 Mar;170:295-300. doi: 10.1016/j.jpeds.2015.11.052. Epub 2015 Dec 24.
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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.
Lisa M Horowitz, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children and Adolescents, run by National Institute of Mental Health (NIMH) 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 1 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: stopped early, as of the sponsor's last update on 16 Sep 2019. 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?
The study was stopped early. 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: 2 years). 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 NCT02050867, which also lists 5 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 16 Sep 2019.