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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT00406159
Eligibility Criteria:
Inclusion Criteria:
* Male and female children 2-10 years diagnosed with autism, PDD, or Aspergers
* No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
* No additional biomedical treatments started 6 weeks prior to enrollment
* No changes in dietary management for 3 months prior to enrollment
* Access to Thoughtful House on a daily basis, or as necessary for the study participation
* In addition, the child participant must be:
* Ambulatory or require minimum support walking, per parent
* Able to sit still for 5 minutes or longer with a preferred toy item, per parent
* Adequate vision and hearing for the purposes of test administration, per parent
* Adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent
* Stable and controlled medical disorder
* Under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
10 Years
Study:
NCT00406159
Study Brief:
Protocol Section:
NCT00406159