Early Detection of Autism Spectrum Disorder in Children

This study is currently recruiting participants.
Verified February 2014 by St. Louis University
Sponsor:
Collaborator:
IntegraGen SA
Information provided by (Responsible Party):
Rolanda Maxim, Assoc. Professor of Pediatrics, St. Louis University
ClinicalTrials.gov Identifier:
NCT01646866
First received: May 17, 2012
Last updated: February 24, 2014
Last verified: February 2014

May 17, 2012
February 24, 2014
December 2010
December 2016   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01646866 on ClinicalTrials.gov Archive Site
Percentage of Children who failed the Red Flags for Communication (RFC) Scale at 12 months who have a Diagnosis of ASD at 24 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Detection of Autism Spectrum Disorder in Children
Early Detection of Autism Spectrum Disorder in Children

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Saliva will be collected

Non-Probability Sample

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

Autism Spectrum Disorder
Not Provided
Siblings of Children with Autism Spectrum Disorders
This group is comprised of 6-12 month old siblings of a child with an expert clinical diagnosis of autism spectrum disorders.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Those children who do not meet the inclusion criteria
  • Those who do not speak English will be excluded from this study.
Both
6 Months to 36 Months
Yes
Contact: Mirza Waseem Baig, MBBS (314) 577-5609 mirzaw_baig@yahoo.com
United States
 
NCT01646866
15861
No
Rolanda Maxim, Assoc. Professor of Pediatrics, St. Louis University
St. Louis University
IntegraGen SA
Principal Investigator: Rolanda Maxim, MD St. Louis University
St. Louis University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP