Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT04317118
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT04317118
Study Brief:
Protocol Section:
NCT04317118