Longitudinal and Biological Study of Childhood Disintegrative Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

May 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004458 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Longitudinal and Biological Study of Childhood Disintegrative Disorder

Official Title ^ICMJE

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening, Longitudinal

Condition ^ICMJE

Pervasive Child Development Disorders
Autism

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

220

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Psychologically diagnosed (DSM-IV) as Childhood Disintegrative Disorder
No known genetic or medical syndrome (Down syndrome or cerebral palsy)
Must speak English

Gender

Both

Ages

2 Years to 9 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004458

Responsible Party

Study ID Numbers ^ICMJE

199/13682, YALE-5P01HD0300830, YALE-HIC-5895

Study Sponsor ^ICMJE

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^ICMJE

Yale University

Investigators ^ICMJE

Study Chair:

Fred Volkmar

Yale University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

October 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP