Protocol Details

Markers of Autism Spectrum Disorders in At-Risk Toddlers: A Pilot Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	11-M-0144
Sponsoring Institute	National Institute of Mental Health (NIMH)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 10 mo Max Age: 20 mo
Referral Letter Required	No
Population Exclusion(s)	None
Special Instructions	Currently Not Provided
Keywords	Autism; Language Acquisition; Language Development; Toddlers
Recruitment Keyword(s)	Autism; Language Development
Condition(s)	Autism; Language Acquisition; Language Development; Toddlers
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Mental Health

The purpose of this study is to learn more about risk factors for autism by studying the behavior and brain functioning of toddlers with early communication delays and typically developing toddlers. Children 12 or 18 months of age with language delays (i.e., no words at 18 months, limited vocalizations at 12 months) and typically developing toddlers may be eligible to participate. This study will be conducted at the NIH Clinical Center in Bethesda, Maryland. There will be an initial screening evaluation that will include behavioral assessment. Eligible participants will then complete a baseline visit that includes an overnight sleep study that includes Electroencephalogram (EEG) test to measure brain electrical activity, and an MRI scan. Follow-up visits that include behavioral assessment will occur every 6-12 months, depending on age at study entry. The final study visit will occur at 36 months of age and will include behavioral assessment, sleep/EEG study, and MRI. There is no cost for participation. Compensation will be provided. To find out if your child qualifies or for more information, please call 301-451-7822 (TTY: 1-866-411-1010) or e-mail NIMH-ASD@mail.nih.gov. National Institute of Mental Health, National Institutes of Health, Department of Health & Human Services.

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Eligibility

INCLUSION CRITERIA:

At-risk Group:

1. 12 or 18 months of age (plus or minus 2 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 2 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

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Citations:

Buschmann A, Jooss B, Rupp A, Dockter S, Blaschtikowitz H, Heggen I, Pietz J. Children with developmental language delay at 24 months of age: results of a diagnostic work-up. Dev Med Child Neurol. 2008 Mar;50(3):223-9. Epub 2008 Feb 11.

Chawarska K, Klin A, Paul R, Volkmar F. Autism spectrum disorder in the second year: stability and change in syndrome expression. J Child Psychol Psychiatry. 2007 Feb;48(2):128-38.

Dager SR, Wang L, Friedman SD, Shaw DW, Constantino JN, Artru AA, Dawson G, Csernansky JG. Shape mapping of the hippocampus in young children with autism spectrum disorder. AJNR Am J Neuroradiol. 2007 Apr;28(4):672-7.

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Contacts:

Principal Investigator	Referral Contact	For more information:
Audrey E. Thurm, Ph.D. National Institute of Mental Health (NIMH) National Institutes of Health BG 10 RM 1C250 MSC 1255 10 CENTER DR BETHESDA MD 20892-1255 (301) 496-5323 at191u@nih.gov	Audrey E. Thurm, Ph.D. National Institute of Mental Health (NIMH) National Institutes of Health BG 10 RM 1C250 MSC 1255 10 CENTER DR BETHESDA MD 20892-1255 (301) 496-5323 at191u@nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01339767

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