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Early Detection of Autism Spectrum Disorder in Children

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ClinicalTrials.gov Identifier: NCT01646866
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
IntegraGen SA
Information provided by (Responsible Party):
Rolanda Gott, Assoc. Professor of Pediatrics, St. Louis University

Brief 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. 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 or disease
Autism Spectrum Disorder

Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Autism Spectrum Disorder in Children
Study Start Date : December 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  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 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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 [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Saliva will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646866


Locations
United States, Missouri
Knights of Columbus Developmental Center
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Louis University
IntegraGen SA
Investigators
Principal Investigator: Rolanda Gott, MD St. Louis University

Publications:

Responsible Party: Rolanda Gott, Assoc. Professor of Pediatrics, Professor of Pediatrics, St. Louis University
ClinicalTrials.gov Identifier: NCT01646866     History of Changes
Other Study ID Numbers: 15861
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Rolanda Gott, Assoc. Professor of Pediatrics, St. Louis University:
autism
siblings
genetic test
screening

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders