Overview

This trial is active, not recruiting.

Condition autism spectrum disorder
Sponsor St. Louis University
Collaborator IntegraGen SA
Start date December 2010
End date December 2016
Trial size 50 participants
Trial identifier NCT01646866, 15861

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
This group is comprised of 6-12 month old siblings of a child with an expert clinical diagnosis of autism spectrum disorders.

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 6 months up to 36 months old.

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.

Additional Information

Official title Early Detection of Autism Spectrum Disorder in Children
Principal investigator Rolanda Gott, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by St. Louis University.