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

Not Applicable

Completed

• Conditions: Autistic Spectrum Disorders
• Interventions: Behavioral: DIR/Floortime; Behavioral: Routine care

• Registration Number: NCT00954083
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2008-10
• Study Completion: 2009-04
• Status Verified: 2009-08
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-05
• Last Update Submitted: 2009-08-05
• Study First Posted: 2009-08-06
• Last Update Posted: 2009-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIR/Floortime intervention	DIR/Floortime	1=DIR/Floortime intervention
routine care	Routine care	2=routine care

Primary Outcome Measures

Name	Time	Method
The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)	at the beginning of the first session and at the 3 months follow up

Secondary Outcome Measures

Name	Time	Method
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