Status:
COMPLETED
Social Cognitive Development in Young Children With Autism
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborating Sponsors:
Autism Speaks
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
24-42 years
Phase:
NA
Brief Summary
Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for...
Eligibility Criteria
Inclusion
- Participants must be 24 to 42 months old
- Children must meet criteria for ASD or autism on the ADOS (Lord et al., 2000) plus receive a clinical judgment of PDD-NOS or autism by the study team
- Score ≥ 16 months on the Visual Receptive subtest and ≥ 9 months on the Receptive Language subtest on the Mullen Scales of Early Learning and/or the Vineland Adaptive Behavior Scales at the time of eligibility testing.
- The parent (or other primary caregiver, such as grandparent) in the PE condition must agree to attend the training sessions each week for the 5-month period.
- The parent must agree to bring their child in for testing at all testing points (pre-testing, post-testing, follow-up testing).
- Parents must be between the ages of 18 and 65 years old
- It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home)
Exclusion
- \<34 weeks or \>42 weeks gestational age
- \<2500 grams birth weight, severe birth trauma
- Head or serious bodily injury sustained before or during the study
- Illicit drug or excessive alcohol exposure (defined in our telephone screening interview)
- Major hearing or visual impairment
- Non-febrile seizures
- Any known genetic syndrome
- Mitochondrial disorders
- Severe birth defects
- No foster children may participate
- The child must not be adopted
- The child must not be participating in another intervention study simultaneously or be simultaneously enrolled in the CARD clinic's Achievements, Early Achievements, TIPS, Jump Start, or Play with Me programs.
- Unable to provide baseline data on the eye tracking measure at time of pretesting (e.g., tracker unable to read eye movements)
- Has a sibling participating in this study
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01425918
Start Date
January 1 2012
End Date
April 1 2015
Last Update
March 10 2021
Active Locations (1)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211