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A Pilot Trial of a Developmental, Individual-Difference, Relationship-Bases (DIR)/Floortime for Children With Autistic Spectrum Disorders

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00954083
First received: August 4, 2009
Last updated: August 5, 2009
Last verified: August 2009
History of Changes
  Purpose

Thirty two children age 2-6 years are recruited into the study and the randomization will be stratified for chronological age and symptom severity into 2 main groups, intervention and control. The intervention group will receive an additional target treatment of DIR/Floortime parent training intervention, while the control group will continue on their routine care for 3 months.

Hypothesis: Children in the intervention group show much improvement in climbing the developmental "ladder" and declining in the autistic behaviors.


Condition Intervention
Autistic Spectrum Disorders
 Behavioral: DIR/Floortime
Behavioral: Routine care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial 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: at the beginning of the first session and at the 3 months follow up ] [ 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: at the beginning of the first session and the 3 months follow up ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: June 2007
Study Completion Date: April 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DIR/Floortime intervention
1=DIR/Floortime intervention
 Behavioral: DIR/Floortime
Developmental, Individual-Difference, Relationship-Bases (DIR) focus more on relationship, social skills, and meaningful, spontaneous use of language and communication and integrated understand of human development
Active Comparator: routine care
2=routine care
 Behavioral: Routine care
Routine care

  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: NCT00954083

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: NCT00954083     History of Changes
Other Study ID Numbers: 194/2550 (EC2)
Study First Received: August 4, 2009
Last Updated: August 5, 2009
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 21, 2013