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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01339767
Eligibility Criteria:
* INCLUSION CRITERIA:
At-risk Group:
1. 12 or 18 months of age (plus or minus 3 months)
2. Limited spoken words (for both the 12 and 18 month groups)
3. Expressive and Receptive scores in the Very Low range on the Mullen Scales of Early Learning (a standardized observational measure),
Typically Developing Group:
1. 12 or 18 months of age (plus or minor 3 months)
2. Development in nonverbal and verbal areas within age expectations (per scores on all 4 domains of the Mullen Scales of Early learning no more than 1.5 standard deviation below the mean).
Healthy Adult Group:
1\. 18-40 years old
EXCLUSION CRITERIA:
At-risk Group:
1. Primary language spoken in the home is other than English
2. Prematurity at birth (defined as less than 36 weeks gestation), or birth weight significantly below normal for gestational age (SGA- small for gestational age) or other significant birth trauma.
3. Motor or other medical impairment deemed responsible for delays (e.g. cerebral palsy; known genetic disorder)
Typically Developing Group:
1. Primary language spoken in the home is other than English
2. Prematurity at birth (defined as less than 36 weeks gestation); or birth weight significantly below normal for gestational age (SGA- small for gestational age).
3. Motor or other medical impairment that would interfere with study participation
4. Known genetic disorder
5. Status as a younger sibling of a child diagnosed with autism
Healthy Adult Group:
1. Historical or current psychiatric, neurological, or serious medical illness
2. Primary language is other than English
3. Difficulty hearing (as some sounds and words will be presented during the MRI scan)
4. Head injury with loss of consciousness in the last year
5. Metal in the body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have.
6. Discomfort in small closed spaces (have claustrophobia) so that there would be discomfort in the MRI machine.
7. Inability to lie comfortably flat on the back for up to 60 minutes in the MRI scanner
8. If female, and pregnant
9. Inability to provide own consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
9 Months
Maximum Age:
21 Months
Study:
NCT01339767
Study Brief:
Protocol Section:
NCT01339767