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NCT01646866 · ClinicalTrials.gov registry record

Early Detection of Autism Spectrum Disorder in Children

A clinical trial of Autism Spectrum Disorder, sponsored by St. Louis University.

Completed
Registry status
37
Enrollment target
1
Study location

NCT01646866 is a study of Autism Spectrum Disorder that has completed, run by St. Louis University. The registered enrollment target is 37 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01646866, a study of Autism Spectrum Disorder, has completed, sponsored by St. Louis University.

COMPLETED
Registry status
37 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Study Locations (1)

Missouri

  • Knights of Columbus Developmental Center - St Louis

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2010-12
Est. Completion 2015-12

Sponsor

St. Louis University

107 total trials

What the Registry Record Tells You About NCT01646866

The ClinicalTrials.gov registry entry for NCT01646866 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (73% lower). The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 0 interventions.

NCT01646866 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT01646866 about?

NCT01646866 is a clinical study titled "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 n...

What is the current status of trial NCT01646866?

This trial is currently completed. The enrollment target is 37 participants. The study started on 2010-12. Estimated completion is 2015-12.

What conditions does trial NCT01646866 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder.

Who is sponsoring clinical trial NCT01646866?

This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01646866 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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