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Study of Toddlers With Language Delay
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Purpose
| Condition |
|---|
| Autism Language Acquisition Language Development Toddlers |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Markers of Autism Spectrum Disorders in At-Risk Toddlers: A Pilot Study |
| Enrollment: | 77 |
| Study Start Date: | April 18, 2011 |
| Estimated Study Completion Date: | June 30, 2017 |
Objective
This investigation will focus on two areas: 1) early communication impairments as predictors of autism spectrum disorder (ASD) and later developmental delays, and 2) the relationship between communication and evidence of CNS function (sleep, EEG) and structure (MRI DTI and volumetrics) in young children at risk for ASD. The objective is to delineate early communicative impairments that predict ASD vs. other developmental delays and to examine how these impairments correlate with brain abnormalities in both structure and function.
Study Population
We will recruit 64 children [n=32 at 12 months of age (plus or minus 2 months); n=32 at 18 months of age (plus or minus 2 months)] who are at-risk for ASD due to communication/language delays (at-risk group). The at-risk children will be matched at initial on chronological age, SES, and sex, to typically developing children (n=75) with no history of developmental delays. These 139 participants will hereafter be referred to as the toddler sample. At the 36 month final visit, diagnostic status (e.g. ASD, non-ASD specific delays, catch up) will be determined for children in the at-risk group. In addition, 10 healthy adults, aged 18-40 will serve as control participants for the purpose of piloting the functional paradigms for the MRI portion of the protocol.
Design
We propose to conduct a prospective, longitudinal study of toddlers at-risk for ASD compared to typically developing toddlers. Children will complete behavioral testing and an overnight Sleep/EEG as well as MRI at either a 12 or 18 month initial. Follow-up visits that include behavioral assessment will occur at 24 and 36 months for all children (and at 18 months of age for the 12-month cohort). The Sleep/EEG and MRI will be repeated at the 36 month final follow-up.
Outcome Measures
Autism symptoms, language status, and cognitive development at 36 months will serve as the primary outcome measures.
Eligibility| Ages Eligible for Study: | 9 Months to 21 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
At-risk Group:
- 12 or 18 months of age (plus or minus 3 months)
- Limited spoken words (for both the 12 and 18 month groups)
- Expressive and Receptive scores in the Very Low range on the Mullen Scales of Early Learning (a standardized observational measure),
Typically Developing Group:
- 12 or 18 months of age (plus or minor 3 months)
- 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:
- Primary language spoken in the home is other than English
- 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.
- Motor or other medical impairment deemed responsible for delays (e.g. cerebral palsy; known genetic disorder)
Typically Developing Group:
- Primary language spoken in the home is other than English
- Prematurity at birth (defined as less than 36 weeks gestation); or birth weight significantly below normal for gestational age (SGA- small for gestational age).
- Motor or other medical impairment that would interfere with study participation
- Known genetic disorder
- Status as a younger sibling of a child diagnosed with autism
Healthy Adult Group:
- Historical or current psychiatric, neurological, or serious medical illness
- Primary language is other than English
- Difficulty hearing (as some sounds and words will be presented during the MRI scan)
- Head injury with loss of consciousness in the last year
- 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.
- Discomfort in small closed spaces (have claustrophobia) so that there would be discomfort in the MRI machine.
- Inability to lie comfortably flat on the back for up to 60 minutes in the MRI scanner
- If female, and pregnant
- Inability to provide own consent
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01339767
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Audrey E Thurm, Ph.D. | National Institute of Mental Health (NIMH) |
More Information
Publications:
| Responsible Party: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT01339767 History of Changes |
| Other Study ID Numbers: |
110144 11-M-0144 |
| Study First Received: | April 20, 2011 |
| Last Updated: | July 1, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
|
Autism Language Acquisition Language Development Toddlers |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |
ClinicalTrials.gov processed this record on August 18, 2017