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

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ClinicalTrials.gov Identifier: NCT00954083
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 6, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Autistic Spectrum Disorders Behavioral: DIR/Floortime Behavioral: Routine care

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2007
Primary Completion Date : October 2008
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

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: at the beginning of the first session and the 3 months follow up ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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): NCT00954083


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

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)
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders