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Clinical Trials/NCT01425918
NCT01425918
Completed
Not Applicable

Effects of Self-Generated Experiences on Social Cognitive Development in Young Children With Autism

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.1 site in 1 country61 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Enrollment
61
Locations
1
Primary Endpoint
Change in Baseline Eye Tracking Tasks
Status
Completed
Last Updated
5 years ago

Overview

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 children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
April 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebecca Landa

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • \<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

Outcomes

Primary Outcomes

Change in Baseline Eye Tracking Tasks

Time Frame: 5 months into treatment and 5 months after the treatment ends

Change in Baseline Spontaneous Imitation Task

Time Frame: 5 months into treatment and 5 months after the treatment ends

Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile

Time Frame: 5 months into treatment and 5 months after the treatment ends

Secondary Outcomes

  • Change in Baseline Action/intention understanding taks(5 months into treatment and 5 months after the treatment ends)
  • Change in Baseline Autism Diagnostic Observation Schedule(5 months into treatment and 5 months after the treatment ends)
  • Change in Baseline Mullen Scales of Early Learning(5 months into treatment and 5 months after the treatment ends)

Study Sites (1)

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