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

Autism Spectrum Disorders Clinical Trial

— DIR  

Official title:

A One-year Prospective Follow-up Study of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954213
• Other study ID #: 206/2551(EC1)
• Status: Completed
• Phase: N/A
• First received: August 4, 2009
• Last updated: July 22, 2010
• Start date: May 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Child Development Disorders, Pervasive

Intervention

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.

Locations

Country	Name	City	State
Thailand	Kingkaew Pajareya	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)		1 year	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)		1 year	Yes