Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Suicidal Ideation
Type
Observational
Design
Observational Model: CohortTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 8 years and 17 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04317118
Collaborators
Not Provided
Investigators
Principal Investigator: Lisa M Horowitz, Ph.D. National Institute of Mental Health (NIMH)