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:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT01425918
Eligibility Criteria:
Inclusion Criteria:
* Participants must be 24 to 42 months old
* Children must meet criteria for ASD or autism on the ADOS (Lord et al., 2000) plus receive a clinical judgment of PDD-NOS or autism by the study team
* Score ≥ 16 months on the Visual Receptive subtest and ≥ 9 months on the Receptive Language subtest on the Mullen Scales of Early Learning and/or the Vineland Adaptive Behavior Scales at the time of eligibility testing.
* The parent (or other primary caregiver, such as grandparent) in the PE condition must agree to attend the training sessions each week for the 5-month period.
* The parent must agree to bring their child in for testing at all testing points (pre-testing, post-testing, follow-up testing).
* Parents must be between the ages of 18 and 65 years old
* It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home)
Exclusion Criteria:
* \<34 weeks or \>42 weeks gestational age
* \<2500 grams birth weight, severe birth trauma
* Head or serious bodily injury sustained before or during the study
* Illicit drug or excessive alcohol exposure (defined in our telephone screening interview)
* Major hearing or visual impairment
* Non-febrile seizures
* Any known genetic syndrome
* Mitochondrial disorders
* Severe birth defects
* No foster children may participate
* The child must not be adopted
* The child must not be participating in another intervention study simultaneously or be simultaneously enrolled in the CARD clinic's Achievements, Early Achievements, TIPS, Jump Start, or Play with Me programs.
* Unable to provide baseline data on the eye tracking measure at time of pretesting (e.g., tracker unable to read eye movements)
* Has a sibling participating in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Months
Maximum Age:
42 Months
Study:
NCT01425918
Study Brief:
Protocol Section:
NCT01425918