Longitudinal and Biological Study of Childhood Disintegra... | NCT00004458

Studies
Longitudinal and Biological Study of Childhood Disintegrative Disorder

NCT00004458

Sponsor

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

Status

Terminated

Last Update Posted

Jun 24, 2005Estimated

Enrollment

220

Phase

Not provided

Conditions

Pervasive Child Development Disorders
Autism

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2003

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1997

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 1999

First Submission Date that Met QC Criteria

Oct 18, 1999

First Posted Date

Oct 19, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Name	Class
Yale University	OTHER

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fred Volkmar	Yale University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale Child Study Center		New Haven	Connecticut	06520	United States
University of Chicago Cancer Research Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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.

ID	Term
D002659	Child Development Disorders, Pervasive
D001321	Autistic Disorder
D009461	Neurologic Manifestations
D001523	Mental Disorders
D035583	Rare Diseases

ID	Term
D065886	Neurodevelopmental Disorders
D000067877	Autism Spectrum Disorder
D009422	Nervous System Diseases
D012816	Signs and Symptoms

ID	Type	Description	Link
YALE-5P01HD0300830
YALE-HIC-5895