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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT00953095
Eligibility Criteria:
Inclusion Criteria:
* Children must be between 24 months and 60 months at entry into the study
* Children must have a clinical diagnosis of autism or PDD-NOS, and/or meet criteria on the ADOS for ASD or autism
* Children must have an age equivalent of 12 months or greater for non-verbal ability based on the Mullen Visual Reception and Fine Motor scales
* Caregiver and child must be available for all assessments
* Children must be able to walk independently
* Parents must be between the ages of 16 and 50 years old
* Family should be currently underserved (inability to obtain services for their child) and have limited family resources
Exclusion Criteria:
* Children must not have a seizure disorder
* Children must not have associated sensory (uncorrected hearing loss greater than 20 db or vision loss) or physical disorders that restrict mobility (e.g., cerebral palsy)
* Children must not have sustained a head injury
* Children's diagnosis of autism spectrum disorder must not be comorbid with other medical syndromes (e.g., Tuberose Sclerosis, Neurofibromatosis, Down syndrome, fragile X) or diseases
* Children must not be in foster care
* English must be the primary language spoken at home
* Parents must not have a psychiatric diagnosis or a diagnosis of mental retardation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Months
Maximum Age:
60 Months
Study:
NCT00953095
Study Brief:
Protocol Section:
NCT00953095