Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT04317118
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.
Detailed Description:
Title:
Validating the Ask Suicide-Screening Questions
(ASQ) for Youth with Autism Spectrum and Neurodevelopmental Disorders
Study Description:\<TAB\>
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.
Objectives:
Primary Objective: The main objective of this study is to develop and assess the efficacy of a suicide screening tool for individuals with ASD/NDD.
Secondary Objectives: 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. 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.
Endpoints:\<TAB\>
Study participation ends when the study measures are completed if/when the study participant does not screen positive on any of the suicide risk measures. If suicidality is detected, they will be treated clinically for suicidal ideation/behavior according to standard clinical practice.
Study:
NCT04317118
Study Brief:
Protocol Section:
NCT04317118