A Pilot Trial of a Developmental, Individual-Difference, Relationship-Bases (DIR)/Floortime for Children With Autistic Spectrum Disorders
DIR
A Pilot Randomized Controlled Trial of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders
1 other identifier
interventional
32
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2007
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedAugust 6, 2009
August 1, 2009
1.3 years
August 4, 2009
August 5, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
DIR/Floortime intervention
EXPERIMENTAL1=DIR/Floortime intervention
routine care
ACTIVE COMPARATOR2=routine care
Interventions
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
Eligibility Criteria
You may qualify if:
- clinical criteria for Autistic Disorders according to DSM IV
- child is 2 - 6 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kingkaew Pajareya, MD
Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
June 1, 2007
Primary Completion
October 1, 2008
Study Completion
April 1, 2009
Last Updated
August 6, 2009
Record last verified: 2009-08