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