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Early Detection of Autism Spectrum Disorder in Children

This study is currently recruiting participants.
Verified March 2013 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: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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.

Condition
Autism Spectrum Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Autism Spectrum Disorder in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Saliva will be collected


Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646866

Contacts
Contact: Mirza Waseem Baig, MBBS (314) 577-5609 mirzaw_baig@yahoo.com

Locations
United States, Missouri
SSM Cardinal Glennon Children's Medical Center Recruiting
St. Louis, Missouri, United States, 63104
Contact: Mirza Waseem Baig     314-577-5609     mirzaw_baig@yahoo.com    
Principal Investigator: Rolanda Maxim, MD            
Sponsors and Collaborators
St. Louis University
IntegraGen SA
Investigators
Principal Investigator: Rolanda Maxim, MD St. Louis University
  More Information

Additional Information:
Study Flyer  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Rolanda Maxim, Assoc. Professor of Pediatrics, Associate Professor of Pediatrics, St. Louis University
ClinicalTrials.gov Identifier: NCT01646866     History of Changes
Other Study ID Numbers: 15861
Study First Received: May 17, 2012
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Louis University:
autism
siblings
genetic test
screening

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013