Autism Spectrum Disorder Clinical Trial
Official title:
Early Detection of Autism Spectrum Disorder in Children
Verified date | March 2017 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Knights of Columbus Developmental Center | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University | IntegraGen SA |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05207956 -
App for Strengthening Services In Specialized Therapeutic Support
|
N/A | |
Completed |
NCT03286621 -
Development of Eye-tracking Based Markers for Autism in Young Children
|
||
Completed |
NCT02608333 -
Efficiency of Early Intervention for Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
Active, not recruiting |
NCT06303791 -
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
|
N/A | |
Enrolling by invitation |
NCT05017779 -
A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth
|
N/A | |
Completed |
NCT04772898 -
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT04987541 -
The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
|
N/A | |
Completed |
NCT04308915 -
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
|
N/A | |
Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
Completed |
NCT03693313 -
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
|
N/A | |
Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
Recruiting |
NCT03812068 -
Parent-mediated Developmental Behavioral Intervention
|
N/A | |
Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
Completed |
NCT02299700 -
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
|
N/A | |
Completed |
NCT03422016 -
Electroretinogram in Autistic Spectrum Disorders
|
||
Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
Recruiting |
NCT05114538 -
Improving the Part C Early Intervention Service Delivery System for Children With ASD
|
N/A |