A Randomized Clinical Trial for Toddlers With ASD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01008800|
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : November 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Social Communication Behavioral: Social communication||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Parent-mediated vs Center-based Intervention for Toddlers With ASD: An RCT|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Experimental: Center-Based classroom intervention
Four days a week for 2.5 hours a day the child will participate in a classroom with peers in an attempt to increase social communication, language abilities, and other skills. Parents will also receive education sessions 1-3 times per month for 1-2 hours each. Treatment will last for 6 months.
Behavioral: Social Communication
The Center-Based classroom intervention focuses on providing children with an invigorating, motivating learning environment in which emerging skills and knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement week may offer the children experiences that they would not otherwise have (Ramey & Ramey, 1998). Parent training sessions will focus on strategies aimed at improving child social engagement and communication and on topics related to autism characteristics, learning styles, interventions, and resources.
Active Comparator: Parent Training
Parents are taught strategies on how to interact with their children to increase their skills. Parent training sessions are given 2 times a month at our center and once a month at home for 60-90 minutes each. Treatment will last for 6 months.
Behavioral: Social communication
Parent training sessions will focus on teaching parents strategies for enhancing their child's social engagement and communication. Since parents will be using these strategies across all activities throughout the day, there is an increased likelihood of generalization. For parents of minority and underserved children, this may be the first exposure to responsive interaction strategies (Rudy & Grusec, 2001).
- Communication and Symbolic Behavior Scales [ Time Frame: immediately after treatment ends and 6 months after treatment ends ]
- Mullen Scales of Early Learning [ Time Frame: immediately after treatment ends and 6 months after treatment ends ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008800
|United States, Maryland|
|Kennedy Krieger Institute|
|Baltimore, Maryland, United States, 21211|
|Principal Investigator:||Rebecca Landa, PhD, CCC-SLP||Hugo W. Moser Research Institute at Kennedy Krieger, Inc.|