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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00954213
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : July 26, 2010
Sponsor:
Information provided by:
Mahidol University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Behavioral: DIR/Floortime parent intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: DIR/Floortime parent intervention Behavioral: DIR/Floortime parent intervention
Parent will be trained to observe their autistic child's cues, follow their child's lead and techniques to enhance his/her development.


Outcome Measures
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Primary Outcome Measures :
  1. The Functional Emotional Assessment Scale (FEAS) Ratings (the child part) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954213


Locations
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Thailand
Kingkaew Pajareya
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Kingkaew Pajareya, MD Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
More Information
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Responsible Party: Associate Professor Dr. Kingkaew Pajareya,M.D., Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
ClinicalTrials.gov Identifier: NCT00954213    
Other Study ID Numbers: 206/2551(EC1)
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: July 26, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders