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A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic (DIR)

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
DIR/Floortime parent intervention
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • clinical criteria for Autistic Disorders according to DSM IV
  • child is 2 - 6 years of age

Exclusion Criteria:

  • children with additional medical diagnosis (e.g., genetic syndromes, diagnosed hearing impairment, diagnosed visual impairment or seizures)
  • children who are geographically inaccessible for follow-up visits
  • their parents are not literate or known chronic psychiatric or physical illness in the parents

Sites / Locations

  • Kingkaew Pajareya

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DIR/Floortime parent intervention

Arm Description

Outcomes

Primary Outcome Measures

The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)

Secondary Outcome Measures

The Childhood Autism Rating Scale (CARS) Clinical rating of the children (6 point scale related to Greenspan's six Functional Development Level -FDL) Satisfaction of the effectiveness of the intervention of their child (Six-point Likert scale)

Full Information

First Posted
August 4, 2009
Last Updated
July 22, 2010
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT00954213
Brief Title
A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic
Acronym
DIR
Official Title
A One-year Prospective Follow-up Study of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Thirty eight autistic spectrum disorder children age 2-6 years recruited into the study. The new treatment intervention is based on the DIR Model. Parents will be coached at the start and then every 3-4 months for 1 year. Outcome will be measured at the first session and at the end of the study using Functional Emotional Assessment Scale and Childhood Autism Rating Scales, Functional Emotional Level, and parent satisfaction rating. Hypothesis of the study: Children who get additional treatment of DIR/floortime show much improvement in climbing the developmental "ladder" and declining in the autistic behaviors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DIR/Floortime parent intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
DIR/Floortime parent intervention
Intervention Description
Parent will be trained to observe their autistic child's cues, follow their child's lead and techniques to enhance his/her development.
Primary Outcome Measure Information:
Title
The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The Childhood Autism Rating Scale (CARS) Clinical rating of the children (6 point scale related to Greenspan's six Functional Development Level -FDL) Satisfaction of the effectiveness of the intervention of their child (Six-point Likert scale)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: clinical criteria for Autistic Disorders according to DSM IV child is 2 - 6 years of age Exclusion Criteria: children with additional medical diagnosis (e.g., genetic syndromes, diagnosed hearing impairment, diagnosed visual impairment or seizures) children who are geographically inaccessible for follow-up visits their parents are not literate or known chronic psychiatric or physical illness in the parents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kingkaew Pajareya, MD
Organizational Affiliation
Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingkaew Pajareya
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic

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