Assessment of Factors Which Predict Improvement in Childr... | NCT00531830

Studies
Assessment of Factors Which Predict Improvement in Children With PDD After a Year of Integrative Therapy

NCT00531830

Sponsor

BeerYaakov Mental Health Center

Status

Unknown status

Last Update Posted

Sep 26, 2007Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Pervasive Developmental Disorder

Interventions

Not provided

Countries

Not provided

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

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Sep 2011Estimated

First Submitted Date

Sep 18, 2007

First Submission Date that Met QC Criteria

Sep 18, 2007

First Posted Date

Sep 19, 2007Estimated

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

Sep 25, 2007

Last Update Posted Date

Sep 26, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the current research is to assess the efficiency of the Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.

An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.

Detailed Description

Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Preschool children with PDD
2		Preschool children without PDD

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with PDD
Children aged from 2 years to 6 years

Exclusion Criteria:

Children with severe retardation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Beatriz Priel, Prof.	Contact	972-8-6472078		bpriel@gmail.com
Alexander Rejba, M.A.	Contact	972-54-4418486		alexrejba@gmail.com

Overall Officials

Name	Affiliation	Role
Irit Orian, M.D.	Mental health unit for preschoolers, Ashdod, Israel	Principal Investigator
Beatriz Priel, Prof.	Ben Gurion University, Beer-Sheva	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002659	Child Development Disorders, Pervasive

Ancestor Terms

ID	Term
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided