Assessing suicide risk in youth with autism and neurodevelopmental disorders
Validating the Ask Suicide-Screening Questions (ASQ) for Youth With Autism Spectrum and Neurodevelopmental Disorders
This study is testing a new screening tool to help identify suicide risk in young people with autism and other developmental disorders.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Trial ID | NCT04317118 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a suicide screening tool specifically for youth with Autism Spectrum Disorder (ASD) and other neurodevelopmental disorders (NDD). Participants aged 8 to 17 will complete four questionnaires during a one-hour session with study staff to evaluate their suicidal thoughts and behaviors. The study will compare the new screening tool's effectiveness against established assessments to ensure it accurately identifies those at risk. The goal is to improve clinical practices and provide better support for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are youth aged 8 to 17 who are currently receiving assessment or treatment for ASD or other NDD.
Not a fit: Patients who are not verbally fluent or unable to communicate effectively may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective method for identifying suicidal ideation in youth with ASD/NDD, ultimately improving their mental health outcomes.
How similar studies have performed: While there is limited research specifically targeting suicide screening in youth with ASD/NDD, similar approaches in other populations have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 or trained study staff, 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.
Where this trial is running
Baltimore, Maryland and 2 other locations
- Kennedy Krieger Institute/Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
- Nationwide Children's Hospital/ Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Lisa M Horowitz, Ph.D. — National Institute of Mental Health (NIMH)
- Study coordinator: Patrick Ryan
- Email: patrick.ryan@nih.gov
- Phone: (301) 443-3906
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.