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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT03935620
Eligibility Criteria:
Inclusion Criteria:
* child age between 18 and 36 months
* developmental age of 9 months as measured on the Visual Reception Scale of the Mullen Scales of Early Learning (MSEL; Mullen, 1995)
* primary diagnosis of Down syndrome as indicated in medical history,
* secondary diagnosis of language delay as measured by a score of at least 1.33 SD below the mean on the Preschool Language Scales -5th Edition (PLS-5; Zimmerman, Steiner, \& Evatt-Pond, 2011),
* hearing (with or without amplification) reported at 25dB HL or better confirmed by audiological testing, or medical record.
Exclusion Criteria:
* concomitant sensory impairments (e.g., hearing impairment, blindness), and
* symptoms of autism spectrum disorder as measured by a result indicating "high risk" for autism (e.g., scores of 8 or higher) on the Modified Checklist for Autism In Toddlers-Revised with Follow-up (MCHAT-R/F Robins, Fein \& Barton, 2009).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
36 Months
Study:
NCT03935620
Study Brief:
Protocol Section:
NCT03935620