AzTrials
AzTrials

Autism Spectrum DisorderNCT01646866

Early Detection of Autism Spectrum Disorder in Children

An observational study of Autism Spectrum Disorder, run by St. Louis University 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
Search all trials

Trial summary

Rationale: Autism Spectrum Disorder (ASD) is defined by deficits in social interaction and communication identified before the age of 3 years. Modified Checklist for Autism in Toddlers (M-CHAT) is a sensitive tool for ASD screening in children 16-23 months. Read more about this study

Who is it for?
Ages 6 to 36 monthsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
How many people
37 participants
Where
1 siteUnited States
Study dates
Dec 2010to Dec 2015
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 6 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Biological siblings of children with a previous expert clinical diagnosis of Autism Spectrum Disorder.

Who may be able to join

  • The subject must be a sibling of a child with a previous expert clinical diagnosis of Autism Spectrum Disorder.
  • Subjects will be included for the genetic test if he/she meets the following criteria:
  • At 12 months of age he/she failed two or more items on the RFC with at least one failed critical item
  • They have no significant known hearing, vision or motor impairment that will impact on their ability to perform on developmental assessments

Who cannot join

  • Those children who do not meet the inclusion criteria
  • Those who do not speak English will be excluded from this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Knights of Columbus Developmental Center

    St Louis, Missouri, 63110

Other trials in United States

About this study

Rationale: Autism Spectrum Disorder (ASD) is defined by deficits in social interaction and communication identified before the age of 3 years. Modified Checklist for Autism in Toddlers (M-CHAT) is a sensitive tool for ASD screening in children 16-23 months. A limited number of studies with a small number of patients have documented the developmental profile of children with ASD during infancy. Retrospective evaluations of videotaped behavior of children with ASD at 8 months and at 12 months identified early signs of ASD. A few studies found early signs of ASD during infancy in siblings of autistic children. Data documenting the age of onset and regression in ASD is controversial and limited. No large prospective studies documented the specific developmental profile of children with ASD starting at 6 months of age. Defining a specific autistic pattern on a developmental screening test could help identify infants at risk for ASD and improve their outcome through earlier diagnosis and treatment. More recently, genetic tests have been shown to aid in early identification of ASD which facilitates earlier intervention. Genetic testing among siblings of children with autism can aid in identification of autism or other related disorders in the siblings.

PURPOSE: The purpose of this study is to learn about the early signs of autism in siblings of children with autism spectrum disorders.

  • The investigators will enroll siblings of children with ASD. Those siblings who completed the Red Flags for Communication scale (RFC) at 6 months and/or at 12 months and failed the RFC at 12 months will be given a genetic screening test.
  • It is the investigators goal to define a specific autistic pattern on a developmental screening test that could help identify sibling infants at risk for ASD and improve their outcome through earlier diagnosis and treatment and to evaluate if the results of the clinical screening test will correlate with the results of the genetic screening test.
Keywords
autism, siblings, genetic test, screening
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01646866
Study groupRoleWhat they receive
Siblings of Children with Autism Spectrum DisordersThis group is comprised of 6-12 month old siblings of a child with an expert clinical diagnosis of autism spectrum disorders.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Children with a High Risk Genetic Score on the ARISK Genetic Test who have a Diagnosis of Autism Spectrum Disorders (ASD) at 24 Months

    Measured: 2 years

Secondary outcomes (1)

  1. Percentage of Children who failed the Red Flags for Communication (RFC) Scale at 12 months who have a Diagnosis of ASD at 24 months

    Measured: 2 years

Timeline

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

  1. First posted20 Jul 2012 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01646866
Sponsor's protocol ID
15861
Status last verified
Mar 2017
First submitted
17 May 2012
Last updated
6 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Robins DL, Fein D, Barton ML, Green JA. The Modified Checklist for Autism in Toddlers: an initial study investigating the early detection of autism and pervasive developmental disorders. J Autism Dev Disord. 2001 Apr;31(2):131-44. doi: 10.1023/a:1010738829569.

    PubMed 11450812

  • Osterling J, Dawson G. Early recognition of children with autism: a study of first birthday home videotapes. J Autism Dev Disord. 1994 Jun;24(3):247-57. doi: 10.1007/BF02172225.

    PubMed 8050980

  • Baranek GT. Autism during infancy: a retrospective video analysis of sensory-motor and social behaviors at 9-12 months of age. J Autism Dev Disord. 1999 Jun;29(3):213-24. doi: 10.1023/a:1023080005650.

    PubMed 10425584

  • Werner E, Dawson G, Osterling J, Dinno N. Brief report: Recognition of autism spectrum disorder before one year of age: a retrospective study based on home videotapes. J Autism Dev Disord. 2000 Apr;30(2):157-62. doi: 10.1023/a:1005463707029. No abstract available.

    PubMed 10832780

  • Osterling JA, Dawson G, Munson JA. Early recognition of 1-year-old infants with autism spectrum disorder versus mental retardation. Dev Psychopathol. 2002 Spring;14(2):239-51. doi: 10.1017/s0954579402002031.

    PubMed 12030690

  • Tuchman RF, Rapin I. Regression in pervasive developmental disorders: seizures and epileptiform electroencephalogram correlates. Pediatrics. 1997 Apr;99(4):560-6. doi: 10.1542/peds.99.4.560.

    PubMed 9093299

  • Goldberg WA, Osann K, Filipek PA, Laulhere T, Jarvis K, Modahl C, Flodman P, Spence MA. Language and other regression: assessment and timing. J Autism Dev Disord. 2003 Dec;33(6):607-16. doi: 10.1023/b:jadd.0000005998.47370.ef.

    PubMed 14714930

  • Lord C, Shulman C, DiLavore P. Regression and word loss in autistic spectrum disorders. J Child Psychol Psychiatry. 2004 Jul;45(5):936-55. doi: 10.1111/j.1469-7610.2004.t01-1-00287.x.

    PubMed 15225337

  • Rogers SJ. Developmental regression in autism spectrum disorders. Ment Retard Dev Disabil Res Rev. 2004;10(2):139-43. doi: 10.1002/mrdd.20027.

    PubMed 15362172

  • Siperstein R, Volkmar F. Brief report: parental reporting of regression in children with pervasive developmental disorders. J Autism Dev Disord. 2004 Dec;34(6):731-4. doi: 10.1007/s10803-004-5294-y.

    PubMed 15679193

  • Stone WL, McMahon CR, Yoder PJ, Walden TA. Early social-communicative and cognitive development of younger siblings of children with autism spectrum disorders. Arch Pediatr Adolesc Med. 2007 Apr;161(4):384-90. doi: 10.1001/archpedi.161.4.384.

    PubMed 17404136

  • Nadig AS, Ozonoff S, Young GS, Rozga A, Sigman M, Rogers SJ. A prospective study of response to name in infants at risk for autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):378-83. doi: 10.1001/archpedi.161.4.378.

    PubMed 17404135

  • Carayol J, Schellenberg GD, Dombroski B, Genin E, Rousseau F, Dawson G. Autism risk assessment in siblings of affected children using sex-specific genetic scores. Mol Autism. 2011 Oct 21;2(1):17. doi: 10.1186/2040-2392-2-17.

    PubMed 22017886

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorder, run by St. Louis University 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 4 inclusion and 2 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 6 Mar 2017. 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.

What does the primary outcome measure?

Percentage of Children with a High Risk Genetic Score on the ARISK Genetic Test who have a Diagnosis of Autism Spectrum Disorders (ASD) at 24 Months (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01646866, which also lists 13 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 6 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in