Early Detection of Autism Spectrum Disorder in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01646866|
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : March 6, 2017
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|
|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|
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.
- 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 ]
- 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
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
|United States, Missouri|
|Knights of Columbus Developmental Center|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Rolanda Gott, MD||St. Louis University|