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 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT02272192
Eligibility Criteria:
Inclusion criteria:
* 12-30 months of age at time of assessment;
* ambulatory and without impairments affecting hand use;
* meets criteria for Autistic Spectrum Disorder on the APA Diagnostic and Statistical Manual, 5th revision criteria and on the Autism Diagnostic Observation Schedule for Toddlers:
* clinical consensus of ASD diagnosis by 2 independent staff (including a licensed psychologist) based on observation as well as record review;
* developmental quotient of \>35 on Mullen Scales of Early Learning;
* normal hearing and vision screen;
* caregiver agreement to comply with all project requirements, including regular videotaping at home with provided equipment.
Exclusion criteria:
* English not a primary language spoken at home;
* absence at 2 or more appointments without prior notice during the intake assessment;
* more than 10 hours per week of 1:1 ABA based treatment;
* other health or genetic conditions (i.e. fragile X syndrome, seizures, prematurity).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Months
Maximum Age:
30 Months
Study:
NCT02272192
Study Brief:
Protocol Section:
NCT02272192