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Longitudinal and Biological Study of Childhood Disintegrative Disorder

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ClinicalTrials.gov Identifier: NCT00004458
Recruitment Status : Terminated
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Yale University
Information provided by:
Office of Rare Diseases (ORD)

Tracking Information
First Submitted Date October 18, 1999
First Posted Date October 19, 1999
Last Update Posted Date June 24, 2005
Study Start Date May 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal and Biological Study of Childhood Disintegrative Disorder
Official Title Not Provided
Brief Summary

OBJECTIVES:

I. Compare the developmental course (language acquisition, diagnostic stability, predictors of outcome, and restricted interests and behaviors) of childhood disintegrative disorder versus autism and non-autistic developmental delays.

II. Collect data on molecular genetics of proband and family members.

Detailed Description

PROTOCOL OUTLINE:

Patients are evaluated with the following questionnaires at ages 2-3 years and again at ages 5-9: The Autism Diagnostic Interview (ADI); The Autism Diagnostic Observation Schedule (ADOS); Assessment of cognitive functioning; Expressive and receptive language; Adaptive functioning; Measures of burden and functional assessment; The Aberrant Behavior Checklist; The Connors Rating Scale - Parent and Teacher version; and Autism Behavior Checklist

An MRI and EEG are performed, and blood samples are collected from patients and family members for molecular genetic studies.

Study Type Observational
Study Design Primary Purpose: Screening
Time Perspective: Longitudinal
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Pervasive Child Development Disorders
  • Autism
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Volkmar FR, Klin A, Marans WD, et al.: Childhood disintegrative disorder. In: Cohen DJ, Volkmar FR.: Handbook of autism and pervasive developmental disorders. 2nd ed., New York, NY: John Wiley, 1997, pp 47-59.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Enrollment
 (submitted: June¬†23,¬†2005)
220
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • Psychologically diagnosed (DSM-IV) as Childhood Disintegrative Disorder
  • No known genetic or medical syndrome (Down syndrome or cerebral palsy)
  • Must speak English
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 9 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00004458
Other Study ID Numbers 199/13682
YALE-5P01HD0300830
YALE-HIC-5895
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators Yale University
Investigators
Study Chair: Fred Volkmar Yale University
PRS Account Office of Rare Diseases (ORD)
Verification Date October 2003