Early Detection of Autism Spectrum Disorder in Children

Autism Spectrum Disorder Clinical Trial

Official title:

Early Detection of Autism Spectrum Disorder in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646866
• Other study ID #: 15861
• Status: Completed
• Phase: N/A
• First received: May 17, 2012
• Last updated: March 2, 2017
• Start date: December 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Locations

Country	Name	City	State
United States	Knights of Columbus Developmental Center	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis University	IntegraGen SA

Country where clinical trial is conducted

United States, 

References & Publications (13)

Baranek GT. Autism during infancy: a retrospective video analysis of sensory-motor and social behaviors at 9-12 months of age. J Autism Dev Disord. 1999 Jun;29(3):213-24. — View Citation

Carayol J, Schellenberg GD, Dombroski B, Genin E, Rousseau F, Dawson G. Autism risk assessment in siblings of affected children using sex-specific genetic scores. Mol Autism. 2011 Oct 21;2(1):17. doi: 10.1186/2040-2392-2-17. — View Citation

Goldberg WA, Osann K, Filipek PA, Laulhere T, Jarvis K, Modahl C, Flodman P, Spence MA. Language and other regression: assessment and timing. J Autism Dev Disord. 2003 Dec;33(6):607-16. — View Citation

Lord C, Shulman C, DiLavore P. Regression and word loss in autistic spectrum disorders. J Child Psychol Psychiatry. 2004 Jul;45(5):936-55. — View Citation

Nadig AS, Ozonoff S, Young GS, Rozga A, Sigman M, Rogers SJ. A prospective study of response to name in infants at risk for autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):378-83. — View Citation

Osterling J, Dawson G. Early recognition of children with autism: a study of first birthday home videotapes. J Autism Dev Disord. 1994 Jun;24(3):247-57. — View Citation

Osterling JA, Dawson G, Munson JA. Early recognition of 1-year-old infants with autism spectrum disorder versus mental retardation. Dev Psychopathol. 2002 Spring;14(2):239-51. — View Citation

Robins DL, Fein D, Barton ML, Green JA. The Modified Checklist for Autism in Toddlers: an initial study investigating the early detection of autism and pervasive developmental disorders. J Autism Dev Disord. 2001 Apr;31(2):131-44. — View Citation

Rogers SJ. Developmental regression in autism spectrum disorders. Ment Retard Dev Disabil Res Rev. 2004;10(2):139-43. Review. — View Citation

Siperstein R, Volkmar F. Brief report: parental reporting of regression in children with pervasive developmental disorders. J Autism Dev Disord. 2004 Dec;34(6):731-4. — View Citation

Stone WL, McMahon CR, Yoder PJ, Walden TA. Early social-communicative and cognitive development of younger siblings of children with autism spectrum disorders. Arch Pediatr Adolesc Med. 2007 Apr;161(4):384-90. — View Citation

Tuchman RF, Rapin I. Regression in pervasive developmental disorders: seizures and epileptiform electroencephalogram correlates. Pediatrics. 1997 Apr;99(4):560-6. — View Citation

Werner E, Dawson G, Osterling J, Dinno N. Brief report: Recognition of autism spectrum disorder before one year of age: a retrospective study based on home videotapes. J Autism Dev Disord. 2000 Apr;30(2):157-62. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years
Secondary	Percentage of Children who failed the Red Flags for Communication (RFC) Scale at 12 months who have a Diagnosis of ASD at 24 months		2 years

External Links

•   Study Flyer