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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT03525951
Eligibility Criteria:
Inclusion - Parents
* Live in a Pennsylvania or New Jersey zip code that is within a 30-mile radius of Weiss Hall at Temple University (STUDY 1) or live in Wisconsin (STUDY 2).
* Have access to the internet and willingness to videoconference (STUDY 1 AND 2)
a. If a family does not have an adequate digital device (e.g., smartphone only) to videoconference and complete testing, we might lend them a device.
* 18 or older (STUDY 1 AND 2)
* Be an adult parent able to consent for the child to participate in the study (parents in this study can include any caregiver who meets these criteria) (STUDY 1 AND 2)
* English dominant (at least 80%) (STUDY 1 AND 2)
* Have no self-reported diagnosed hearing loss (or no concerns if they have not been tested) (STUDY 1 AND 2).
* Have no reported disabling developmental or acquired disorders or impairments that might significantly affect their performance beyond autism spectrum disorder (ASD) or speech-language disorders (e.g., legal blindness, Down Syndrome, traumatic head injury, stroke) (STUDY 1 AND 2).
Inclusion - Children, Typically Developing Group (TD) (Study 1 and 2)
* age 1 year 4 months - 1 year 8 months 30 days at the start of testing
* English dominant (at least 80%)
* No parent-reported diagnosed hearing loss (or no concerns if the child has not been tested).
* Have typical language abilities as evidenced by meeting two criteria:
1. Score above the 10th percentile on the Mac Arthur Communicative Development Inventories-Words and Sentences (CDI-WS; long form) Complexity section using sex-specific norms.
2. Score above the 10th percentile on the CDI-WS (long form) Words Produced using sex-specific norms
* Meet cognitive inclusion criteria: Score greater than or equal to 81.25 standard score (-1.25 SD) on the Cognition subtest of the DAYC-2
* Have no parent reported disabling developmental or acquired disorders/impairments that might significantly affect their performance including speech- language disorders (e.g., ASD, DLD, cancer, stroke, legal blindness, intellectual disability, Down Syndrome, traumatic head injury, cerebral palsy, seizures, or a genetic condition associated with neurodevelopmental disability).
* Pass the Modified Checklist for Autism in Toddlers-Revised with Follow-Up screener
Inclusion - Children, DLD Group (study 1 and 2)
* age 2 years 6 months - 4 years 0 months 0 days at the start of testing
* English dominant (at least 80%)
* No parent-reported diagnosed hearing loss (or no concerns if the child has not been tested).
* Qualify as at risk for persistent language disorder by meeting two criteria:
1. Score at or below the 10th percentile on the Mac Arthur-Bates Communicative Development Inventory-III (CDI-III) Sentences section using sex-specific norms. For children over 37 mos., score must be less than or equal to the 10th percentile equivalent for 37 mos.
2. Score at or below the 10th percentile on the CDI-III Vocabulary section using sex-specific norms. For children over 37 mos., score must be less than or equal to the 10th percentile equivalent for 37 mos. The child must also produce at least 10 different words on either the CDI-III or CDI-Words and Sentences (CDI-WS long form).
* Meet cognitive inclusion criteria: Score greater than or equal to 70 standard score (-2 SD) on the Cognition subtest of the DAYC-2 (Voress et al., 2012).
* Have no parent reported disabling developmental or acquired disorders/impairments that might significantly affect their performance beyond speech- language disorders (e.g., ASD, cancer, stroke, legal blindness, intellectual disability, Down Syndrome, traumatic head injury, cerebral palsy, seizures, or a genetic condition associated with neurodevelopmental disability other than DLD).
* Pass the Modified Checklist for Autism in Toddlers-Revised with Follow-Up screener
Inclusion - Children, DLD+ASD Group (STUDY 2)
* 2 years 6 months - 4 years 0 months 0 days at the start of testing
* English dominant (at least 80%)
* No parent-reported diagnosed hearing loss (or no concerns if the child has not been tested).
* Have received ASD diagnosis from a healthcare professional prior to beginning the study.
* Qualify as at risk for persistent language disorder by meeting two criteria:
1. Score at or below the 10th percentile on the Mac Arthur-Bates Communicative Development Inventory-III (CDI-III) Sentences section using sex-specific norms.
For children over 37 mos., score must be less than or equal to the 10th percentile equivalent for 37 mos.
2. Score at or below the 10th percentile on the CDI-III Vocabulary section using sex-specific norms. For children over 37 mos., score must be less than or equal to the 10th percentile equivalent for 37 mos. The child must also produce at least 10 different words on either the CDI-III or CDI-Words and Sentences (CDI-WS long form).
* Meet cognitive inclusion criteria: Score greater than or equal to 70 standard score (-2 SD) on the Cognition subtest of the DAYC-2 (Voress et al., 2012).
* Have no parent reported disabling developmental or acquired disorders/impairments that might significantly affect their performance beyond speech-language disorders or ASD (e.g., cancer, stroke, legal blindness, intellectual disability, Down Syndrome, traumatic head injury, cerebral palsy, seizures, or a genetic condition associated with neurodevelopmental disability other than ASD/DLD).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Months
Study:
NCT03525951
Study Brief:
Protocol Section:
NCT03525951