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

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00954083

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:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
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
DIR/Floortime intervention: Experimental 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
routine care: Active Comparator 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:	Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand ( Associate Professor Dr. Kingkaew Pajareya,M.D. )
Study ID Numbers:	194/2550 (EC2)
Study First Received:	August 4, 2009
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00954083 History of Changes
Health Authority:	Thailand: Ethical Committee

Study placed in the following topic categories:

Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders

Autistic Disorder
Mental Disorders Diagnosed in Childhood
Autism

Additional relevant MeSH terms:

Child Development Disorders, Pervasive
Pathologic Processes
Disease

Mental Disorders
Autistic Disorder
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on September 11, 2009