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:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT04078061
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of ASD based on expert evaluation, including both: (1) Confirmation by a research-reliable administration of the Autism Diagnostic Observation Schedule-2 (ADOS-2), OR confirmation by a routine clinical assessment and observation when a research-reliable ADOS-2 is not able to be collected due to COVID-19 restrictions, and (2) A symptom checklist based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
* In process of being approved or already approved through TRICARE for ABA services
* Not yet receiving ABA services
* With no plans to move location for the 6 month intervention period
* Medications have been stable for the 6 weeks prior to enrollment in the study
* Family demonstrates proficiency in written and spoken English
Exclusion Criteria:
* Diagnosis of genetic disorders known to be associated with ASD such as Fragile X, Down syndrome, or tuberous sclerosis
* Severe motor disabilities such as cerebral palsy that prevents walking or any diagnosis which might prevent standard implementation of the intervention
* Profound uncorrected vision or hearing loss
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
5 Years
Study:
NCT04078061
Study Brief:
Protocol Section:
NCT04078061