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Validation of the Ask Suicide-Screening Questions (ASQ) in the Inpatient Medical Setting

This study is currently recruiting participants.
Verified September 27, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02050867
First Posted: January 31, 2014
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Boston Children’s Hospital
Children's Research Institute
Nationwide Children s Hospital in Columbus, Ohio
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
  Purpose

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.


Condition
Children Adolescents

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of the Ask Suicide-Screening Questions (ASQ) in the Inpatient Medical Setting

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):

Primary Outcome Measures:
  • Primary outcome measures include frequencies of positive responses to all ASQ and SIQ items. [ Time Frame: 2 years ]

Estimated Enrollment: 600
Study Start Date: January 29, 2014
Estimated Study Completion Date: July 1, 2018
Estimated Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:<TAB>

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)

EXCLUSION CRITERIA:<TAB>

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050867


Contacts
Contact: Lisa M Horowitz, Ph.D. (301) 435-6052 horowitzl@mail.nih.gov

Locations
United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, D.C., District of Columbia, United States
United States, Massachusetts
Childrens Hospital, Boston Recruiting
Boston, Massachusetts, United States, 02115
United States, Ohio
Childrens Hospital, Columbus Recruiting
Columbus, Ohio, United States, 43205-2696
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Boston Children’s Hospital
Children's Research Institute
Nationwide Children s Hospital in Columbus, Ohio
Investigators
Principal Investigator: Lisa M Horowitz, Ph.D. National Institute of Mental Health (NIMH)
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT02050867     History of Changes
Other Study ID Numbers: 999914044
14-M-N044
First Submitted: January 29, 2014
First Posted: January 31, 2014
Last Update Posted: October 19, 2017
Last Verified: September 27, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Youth Suicide
Suicide

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms