Back to resultsA Pilot Trial of a Developmental, Individual-Difference, Relationship-Bases (DIR)/Floortime for Children With Autistic Spectrum Disorders (DIR)
Primary Purpose
Autistic Spectrum Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DIR/Floortime
Routine care
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Spectrum Disorders
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DIR/Floortime intervention
routine care
Arm Description
1=DIR/Floortime intervention
2=routine care
Outcomes
Primary Outcome Measures
The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00954083
Brief Title
A Pilot Trial of a Developmental, Individual-Difference, Relationship-Bases (DIR)/Floortime for Children With Autistic Spectrum Disorders
Acronym
DIR
Official Title
A Pilot Randomized Controlled Trial of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Spectrum Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DIR/Floortime intervention
Arm Type
Experimental
Arm Description
1=DIR/Floortime intervention
Arm Title
routine care
Arm Type
Active Comparator
Arm Description
2=routine care
Intervention Type
Behavioral
Intervention Name(s)
DIR/Floortime
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Routine care
Intervention Description
Routine care
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
at the beginning of the first session and the 3 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kingkaew Pajareya, MD
Organizational Affiliation
Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Pilot Trial of a Developmental, Individual-Difference, Relationship-Bases (DIR)/Floortime for Children With Autistic Spectrum Disorders
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