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Ask Suicide-Screening Questions (ASQ) for Youth With Autism Spectrum and Neurodevelopmental Disorders

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ClinicalTrials.gov Identifier: NCT04317118
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief 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). 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.


Condition or disease
Suicidal Ideation

Detailed Description:

OBJECTIVE:

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. The main objective of this study is to develop and assess the efficacy of a suicide screening tool for individuals with ASD/NDD. More specifically:

Aim 1: 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.

Aim 2: 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.

STUDY POPULATION:

This is a multisite study that will take place at NIH, within the Neurodevelopmental and Behavioral Phenotyping Service and two other sites: Kennedy Krieger Institute, in Baltimore, MD and Nationwide Children s Hospital in Columbus, OH. The study population will be patients at the participating sites, ages 8 to 17, diagnosed with ASD/NDD or enrolled in a clinic or research clinic that serves patients with neurodevelopmental concerns. This is a newly proposed study that will incorporate pilot data already collected from protocol 12-M- N034.

DESIGN:

This will be a prospective instrument validation study. Potential participants will be patients presenting to outpatient health clinics at the three study hospitals. Study staff will consult with a charge nurse , unit coordinator, or someone who knows the roster of patients in order to identify potential subjects to be approached for consent. Following informed consent and assent procedures, study staff will administer the following measures to patients: the Ask Suicide-Screening Questions for Youth with Autism and Intellectual Disability Candidate Items (ASQ-AID Candidate Items that includes the four ASQ items), an Understanding Death Assessment, the Suicidal Ideation Questionnaire - Child Version (SIQ-CV; About my Life ), and the Study Evaluation Questionnaire. A study team member will ask the parents/guardians to complete a caregiver corroboration survey: the Ask Suicide-Screening Questions for Youth with Autism and Intellectual Disability Caregiver Form (ASQ-AID Caregiver Form). A mental health clinician will fill out supplemental forms: including the Clinician s Brief Suicide Safety Assessment (BSSA) Form and when applicable, the Clinician Follow-up Form approximately one month after the initial study visit. One week after data collection, a study team member will conduct the Parent Follow-up Interview. When resources are not available at a site the Clinician Follow-up Form and the Parent Follow-up Form will be omitted.

OUTCOME MEASURES:

The primary outcome measure is the ASQ-AID Candidate Items, which will be tested against the clinician s BSSA, the SIQ-CV, along with the ASQ-AID Caregiver Form. Secondary outcome measures include data from the Research Assistant Evaluation Form, Understanding Death Assessment, and the Clinician Follow-up Form.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validating the Ask Suicide-Screening Questions (ASQ) for Youth With Autism Spectrum and Neurodevelopmental Disorders
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : September 18, 2023
Estimated Study Completion Date : September 18, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Group/Cohort
Neurodevelopmental
Individuals between 8 and 17 years old with neurodevelopmental disorders



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals in either inpatient or outpatient behavioral health settings or research settings.
Criteria
  • INCLUSION CRITERIA:

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, 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.
  • A legal guardian must provide permission and participant must sign an assent document or provide verbal assent.

EXCLUSION CRITERIA:

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

INCLUSION OF VULNERABLE PARTICIPANTS:

-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.


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): NCT04317118


Contacts
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Contact: Annabelle Mournet (301) 443-3906 annabelle.mournet@nih.gov

Locations
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United States, Illinois
Nationwide Children's Hospital/ Ohio State University
Columbus, Illinois, United States, 43210
Contact: Christin McDonald-Fix, M.D.    Not Listed    Christin.McDonald-Fix@nationwidechildrens.org   
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Contact: Paul Lipkin, MD    Not Listed    lipkin@kennedykrieger.org   
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Lisa M Horowitz, Ph.D. National Institute of Mental Health (NIMH)
Additional Information:
Publications:
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT04317118    
Other Study ID Numbers: 200066
20-M-0066
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: May 8, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Suicide Ideation
Suicide Screening
Death
Children
Adolescents
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Neurodevelopmental Disorders
Self-Injurious Behavior
Behavioral Symptoms
Mental Disorders