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 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT01881750
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview - Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), and expert clinical opinion
* Outpatients between 2.0 and 6 years of age of either gender
* Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
* Language delay as measured by the Preschool Language Scale 4th ed. (PLS-4)
* Participants must have the ability to make meaningful vocalizations, defined as the ability to make contingent vocalizations when prompted (i.e., vocal sound showing intent to communicate, but not necessarily clear words)
* Stable psychotropic medication(s) or biomedical interventions for at least one month prior to baseline measurements with no anticipated changes during study participation
* Stable behavioral treatment (Applied Behavioral Analysis, Floortime, or other interventions), speech therapy, and school placement for at least 2 months prior to baseline measurements with no expected changes during study participation
* No more than 60 minutes of 1:1 speech therapy per week
* The availability of at least one parent who can consistently participate in the group treatment and related activities of the research study
* Be male or female in good medical health
* Will be starting PRTG after the first magnetic resonance image (MRI) scan has occured and, if agreeable, blood draw or saliva sample
* Parents intend on continuing PRTG for a minimum of 12 weeks
* Parents must be 18 years of age or older.
Exclusion Criteria:
* A current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder…)
* A genetic abnormality, such as Fragile X, based on genetic testing, done as indicated
* Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
* Participants taking psychotropic medications will not be included if their medications have not been stable for over a week
* Parents who do not have the ability to videotape parent and child interactions on a weekly basis
* Parents who are not willing to implement intervention strategies for at least one hour a day
* Parents who plan to alternate which parent attends the group sessions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
6 Years
Study:
NCT01881750
Study Brief:
Protocol Section:
NCT01881750