Study of Toddlers With Language Delay

NCT01339767 | Completed

• 2 other identifiers: 11014411-M-0144
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism; Language Acquisition; Language Development; Toddlers

Keywords

Autism; Language Acquisition; Language Development; Toddlers

Eligibility Criteria

• Age: 9 Months - 21 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• At-risk Group:
• 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:
• 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:
• \. 18-40 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (6)

• 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. doi: 10.1111/j.1469-8749.2008.02034.x. Epub 2008 Feb 11.

  PMID: 18266869 BACKGROUND

• 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. doi: 10.1111/j.1469-7610.2006.01685.x.

  PMID: 17300551 BACKGROUND

• 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.

  PMID: 17416819 BACKGROUND

• Hong X, Farmer C, Kozhemiako N, Holmes GL, Thompson L, Manwaring S, Thurm A, Buckley A. Differences in sleep EEG coherence and spindle metrics in toddlers with and without receptive/expressive language delay: a prospective observational study. J Neurodev Disord. 2025 Feb 22;17(1):11. doi: 10.1186/s11689-024-09586-1.

  PMID: 39987026 DERIVED

• Hong X, Farmer C, Kozhemiako N, Holmes GL, Thompson L, Manwaring S, Thurm A, Buckley A. Differences in Sleep EEG Coherence and Spindle Metrics in Toddlers With and Without Language Delay: A Prospective Observational Study. Res Sq [Preprint]. 2024 Feb 14:rs.3.rs-3904113. doi: 10.21203/rs.3.rs-3904113/v1.

  PMID: 38410470 DERIVED

• Smith EG, Condy E, Anderson A, Thurm A, Manwaring SS, Swineford L, Gandjbakhche A, Redcay E. Functional near-infrared spectroscopy in toddlers: Neural differentiation of communicative cues and relation to future language abilities. Dev Sci. 2020 Nov;23(6):e12948. doi: 10.1111/desc.12948. Epub 2020 Mar 20.

  PMID: 32048419 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Audrey E Thurm, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 21, 2011
• Study Start: April 18, 2011
• Study Completion: June 30, 2017
• Last Updated: December 12, 2019

Record last verified: 2017-06-30

Locations

US (1)