Longitudinal and Biological Study of Childhood Disintegrative Disorder

Autism Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00004458
• Other study ID #: 199/13682
• Secondary ID: YALE-5P01HD03008
• Status: Terminated
• Phase: N/A
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: May 1997

Study information

• Verified date: October 2003
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 220
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 9 Years

Eligibility

• Psychologically diagnosed (DSM-IV) as Childhood Disintegrative Disorder

• No known genetic or medical syndrome (Down syndrome or cerebral palsy)

• Must speak English

Study Design

Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Autism
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Pervasive Child Development Disorders

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.