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

Autistic Spectrum Disorders Clinical Trial

— DIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954083
• Other study ID #: 194/2550 (EC2)
• Status: Completed
• Phase: N/A
• First received: August 4, 2009
• Last updated: August 5, 2009
• Start date: June 2007
• Est. completion date: April 2009

Study information

• Verified date: August 2009
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Autistic Spectrum Disorders
• Child Development Disorders, Pervasive

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
Routine care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)		at the beginning of the first session and at the 3 months follow up	Yes
Secondary	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	Yes