Development of an Intervention for Preschoolers With Autism
The purpose of this study is to test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children with autism spectrum disorder (ASD). Through interactive development (continually seeking educator feedback for intervention improvement) and implementation of the intervention, the investigators hope to provide a feasible and practical means for educators to work with children with ASD in real world, large scale settings. ASD preschool educators, the children enrolled in their classes, between the ages of 3 and 6 years and their families may join.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Development of a Social and Communication Intervention for Preschoolers With Autism|
- Change in educator instruction to meet fidelity of intervention. [ Time Frame: approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention ] [ Designated as safety issue: No ]Fidelity will be monitored throughout the duration of the intervention by KKI staff to assess the quality and consistency with which educators implement the intervention.
- Change in Baseline Autism Diagnostic Observation Schedule [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]
- Change in Baseline Mullen Scales of Early Learning [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]
- Change in Child's Baseline Spontaneous Imitation Task [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]
- Change in Child Classroom-based Social Communication Performance [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]
- Change in parent perception of child behavior as recorded by the Autism Composite score of the PDDBI (parent version) [ Time Frame: 9 months into treatment ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: ISC+PRT Intervention
For the duration of at least one school year children will receive 45-90 minutes of intervention in the classroom in an attempt to increase social and communication skills.
Behavioral: ISC+PRT Intervention
Teachers will be trained to implement an intervention in preschool ASD classrooms that provides a learning environment in which social and communication skills are focused on.
No Intervention: Instruction As Usual
For the duration of at least one year children will receive the typical classroom instruction
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591707
|United States, Maryland|
|Kennedy Krieger Institute/Baltimore County Public Schools|
|Baltimore City/County, Maryland, United States|
|Principal Investigator:||Rebecca Landa, PhD, CCC-SLP||Hugo W. Moser Research Institute at Kennedy Krieger, Inc.|