Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00954213
First received: August 4, 2009
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention
Autism Spectrum Disorders
 Behavioral: DIR/Floortime parent intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • The Functional Emotional Assessment Scale (FEAS) Ratings (the child part) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954213

Locations
Thailand
Kingkaew Pajareya
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Kingkaew Pajareya, MD Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
  More Information

No publications provided

Responsible Party: Associate Professor Dr. Kingkaew Pajareya,M.D., Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
ClinicalTrials.gov Identifier: NCT00954213     History of Changes
Other Study ID Numbers: 206/2551(EC1)
Study First Received: August 4, 2009
Last Updated: July 22, 2010
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013