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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03782493
Eligibility Criteria:
Inclusion Criteria:
* Parent or caregiver (mother, father, grandparent) willing to participate in caregiver training over the full 18 months of the study
* Normal non-verbal cognitive abilities
* Receptive and expressive language delay:
* English as the only language spoken to the child in the home
* Provision of signed and dated informed consent form
* Attempts to imitate 10 words
Exclusion Criteria:
* Diagnosis of a neurodevelopmental disability other than DLD (e.g., Down syndrome, ASD, intellectual disability)
* Caregiver report of a major medical condition (e.g., seizures, cancer, stroke, traumatic head injury, cleft lip/palate, cerebral palsy, legally blind, any genetic diagnosis associated - - Caregiver report of preterm birth (i.e., \< 37 weeks gestation)
* Caregiver report of hearing impairment or audiological testing indicating hearing thresholds \> 20dB
* Caregiver report or direct observation of any problems chewing, sucking through a straw, or blowing bubbles.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
27 Months
Maximum Age:
31 Months
Study:
NCT03782493
Study Brief:
Protocol Section:
NCT03782493