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AutismNCT01339767

Study of Toddlers With Language Delay

An observational study of Autism and Language Acquisition, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 21 monthsHealthy volunteers can take part
Conditions the study is for
Autism, Language Acquisition, Language Development
How many people
77 participants
Where
1 siteUnited States
Study dates
18 Apr 2011to 30 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 21 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Keywords
Autism, Language Acquisition, Language Development, Toddlers
Medical subject headings
Autistic Disorder

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2011 (estimated)
  2. Study start18 Apr 2011
  3. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01339767
Sponsor's protocol ID
110144
Other IDs
11-M-0144
Status last verified
30 Jun 2017
First submitted
20 Apr 2011
Last updated
12 Dec 2019
Results posted
No

Publications

  • 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.

    PubMed 18266869

  • 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.

    PubMed 17300551

  • 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.

    PubMed 17416819

  • 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.

    PubMed 39987026

  • 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.

    PubMed 38410470

  • 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.

    PubMed 32048419

Questions about this trial

What is this clinical trial studying?

An observational study of Autism and Language Acquisition, run by National Institute of Mental Health (NIMH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01339767, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.

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