A Pilot Randomized Controlled Trial of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders

Mahidol University0 sites32 target enrollmentJune 2007

ConditionsAutistic Spectrum Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autistic Spectrum Disorders
Sponsor: Mahidol University
Enrollment: 32
Primary Endpoint: The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

April 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mahidol University

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

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)(at the beginning of the first session and the 3 months follow up)