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

Study Overview
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Brief Summary
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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.

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

Conditions
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Autistic Spectrum Disorders

Intervention / Treatment
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* Behavioral: DIR/Floortime
* Behavioral: Routine care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIR/Floortime intervention<br>1=DIR/Floortime intervention | Behavioral: DIR/Floortime<br>* 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<br>|
| Active Comparator: routine care<br>2=routine care | Behavioral: Routine care<br>* Routine care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |