Kennedy Krieger Institute
Baltimore, Maryland, 21211, United States
NCT Number: NCT00106210
This study will determine the impact of early intervention on the communication and social development of toddlers with autism.
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Notify Me18 month–33 month
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21211, United States
Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism.
Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Early intervention blending several different treatment approaches, with a focus on certain skills
Early intervention blending several different treatment approaches
Time frame: Pre-tx, Post-tx, and 6 month follow up
Time frame: Pre-tx, Post-tx, and 6 month follow up
Time frame: Pre-tx, Post-tx, and 6 month follow up
Time frame: Pre-tx, Post-tx, and 6 month follow up
Time frame: Pre-tx, Post-tx, and 6 month follow up
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Other
Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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