A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic - Full Text View

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00954213

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:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 ]

Estimated Enrollment:	40
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
DIR/Floortime parent intervention: Experimental	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

Contacts

Contact: Kingkaew - Pajareya, M.D.	66-1-02 419-7506	sikpj@mahidol.ac.th
Contact: Kaewta - Nopmaneejumruslers, M.D.	66-1-02-441-0602-8 ext 1211	k_lekagul@hotmail.com

Locations

Thailand, Bangkok
Kingkaew Pajareya	Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Kingkaew Pajareya, M'D 02-419-7506 ext - sikpj@mahidol.ac.th
Contact: Kaewta - Nopmaneejumruslers, M.D. 02-441-0602-8 ext - k_lekagul@hotmail.com

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:	206/2551(EC1)
Study First Received:	August 4, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00954213 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
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on September 11, 2009