Use of the Ask Suicide-Screening Questions (ASQ) in Pediatric Outpatient Settings

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

525

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Childrens Hospital, Boston
    • Missouri
      • Kansas City, Missouri, United States
        • The Childrens Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • 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).

EXCLUSION CRITERIA:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary outcome measures include frequencies of positive responses to all ASQ and SIQ items.
Time Frame: Ongoing
Ongoing

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2016

Primary Completion (Actual)

May 10, 2018

Study Completion (Actual)

April 22, 2020

Study Registration Dates

First Submitted

July 9, 2016

First Submitted That Met QC Criteria

July 9, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999916130
  • 16-M-N130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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