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Protocol Details

Validating the Ask Suicide-Screening Questions (ASQ) for Youth with Autism Spectrum and Neurodevelopmental Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-M-0066

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 8 Years
Max Age: 17 Years

Referral Letter Required

Yes

Population Exclusion(s)

Non-English Speaking

Keywords

Suicidal Ideation;
Suicide Screening;
Death;
Children;
Adolescents

Recruitment Keyword(s)

None

Condition(s)

Suicidal Ideation

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental Health

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.

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Eligibility

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.


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Citations:

Horowitz LM, Thurm A, Farmer C, Mazefsky C, Lanzillo E, Bridge JA, Greenbaum R, Pao M, Siegel M; Autism and Developmental Disorders Inpatient Research Collaborative (ADDIRC). Talking About Death or Suicide: Prevalence and Clinical Correlates in Youth with Autism Spectrum Disorder in the Psychiatric Inpatient Setting. J Autism Dev Disord. 2018 Nov;48(11):3702-3710. doi: 10.1007/s10803-017-3180-7.

Horowitz LM, Bridge JA, Teach SJ, Ballard E, Klima J, Rosenstein DL, Wharff EA, Ginnis K, Cannon E, Joshi P, Pao M. Ask Suicide-Screening Questions (ASQ): a brief instrument for the pediatric emergency department. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1170-6. doi: 10.1001/archpediatrics.2012.1276.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lisa M. Horowitz, Ph.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CRC BG RM 6-5362
10 CENTER DR
BETHESDA MD 20892
(301) 435-6052
horowitzl@mail.nih.gov

Patrick Ryan
National Institute of Mental Health (NIMH)

(301) 496-4588
patrick.ryan@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04317118

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