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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT03404505
Eligibility Criteria:
Inclusion Criteria:
* Child participants must be between the ages of 8 months and 12 months at the beginning of the study.
* Family must speak English at least 75% in the home.
* Children must receive an AOSI concern score ≥7 OR
* a T-score of ≤39 on either the Mullen Receptive Language or Expressive Language subscale. OR
* Score in the Concern range on either the Composite or Total Score of the parent-completed Communication and Symbolic Behavior Scales Developmental Profile (CSBS DP) Infant-Toddler Checklist.
Exclusion Criteria:
* History of head injury, seizure disorder, severe aggression or self-injurious behavior, prenatal illicit drug or excessive alcohol exposure.
* Any hearing or visual impairment
* Any severe birth trauma
* Any birth defects or genetic disorders
* Gestational age \< 35 weeks and/or Birth weight less than 1,500g
* Cannot be living in foster care.
* Location of in-home visits \>35 miles of the Center for Autism and Related Disorders
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Months
Maximum Age:
12 Months
Study:
NCT03404505
Study Brief:
Protocol Section:
NCT03404505