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
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.
To develop and assess the efficacy of a suicide screening tool for people with ASD/NDD.
Youth ages 8 to 17 who are engaged in assessment or treatment at the NIMH for ASD or other NDD
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|
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.
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.
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
Individuals between 8 and 17 years old with neurodevelopmental disorders
- 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.
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
|Contact: Annabelle Mournet||(301) email@example.com|
|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 firstname.lastname@example.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 email@example.com|
|Principal Investigator:||Lisa M Horowitz, Ph.D.||National Institute of Mental Health (NIMH)|