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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT03131635
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Autism Spectrum Disorder based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), DSM-5, and expert clinical opinion;
* Males and females in good medical health between 2.0 and 5 years 11 months;
* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
* Stable treatment (e.g., applied behavior analysis), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation;
* Availability of at least one English-speaking parent who can consistently participate in parent training and research measures;
* Clinical Global Impression(CGI) Severity Social Interaction and Communication Integrated Subscale ≥4;
* Meet the cutoff for Autism on the ADOS-2.
Exclusion Criteria:
* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
* A well-established genetic syndrome, such as Fragile X;
* Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
* Child's primary language other than English;
* Previous adequate trial or training of a developmentally based intervention;
* Participants living more than 45 miles from Stanford University;
* Children with more than 20 hours of in-home ABA;
* At least one room of the house must be available to be dedicated to treatment during session times;
* There must be no serious health and safety risks present in the home environment;
* The research team has the right to refuse to perform sessions in-home even if the criteria above are met.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
5 Years
Study:
NCT03131635
Study Brief:
Protocol Section:
NCT03131635