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Clinical Trials/NCT02617342
NCT02617342
Completed
N/A

Robot-Mediated Social Skills Intervention for Children With Autism Spectrum Disorders

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.1 site in 1 country40 target enrollmentNovember 1, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Enrollment
40
Locations
1
Primary Endpoint
Change in baseline emotions accurately identified on the Transporters Quiz
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

This study is being done to examine the impact of an interactive, social robotics program in helping children with autism spectrum disorders (ASD) understand emotions and how to better recognize emotions while interacting with others. Eligible families will be randomized to either the robot intervention (n=20) or a no intervention (TAU; n=20) condition for 8-14 weeks. Assessments will occur at pre- and post-intervention as well as weekly for both conditions.

Registry
clinicaltrials.gov
Start Date
November 1, 2015
End Date
February 1, 2018
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebecca Landa

Director of the Center for Autism and Related Disorders (CARD) and Professor, Johns Hopkins

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

Eligibility Criteria

Inclusion Criteria

  • Child participants must be between the ages of 4 years, 0 months and 8 years, 11 months.
  • Children must meet criteria for ASD or autism on the Autism Diagnostic Observation Schedule (ADOS-2; Lord et al., 2012) plus receive a clinical judgment of pervasive developmental disorder not otherwise specified (PDD-NOS) or autism by the study team.
  • Children must possess sufficient expressive language skills to qualify for at least an ADOS-2 Module
  • Caregivers must agree to participate in the study and commit to having their child participating in the intervention to which they are randomized for approximately three months.
  • Caregivers must agree to bring their child in for pre-testing and post-testing.
  • Family must speak English at least 50% in the home.

Exclusion Criteria

  • Child IQ \<70 (per Stanford Binet short form).
  • History of head injury, seizure disorder, severe aggression or self-injurious behavior.
  • Vision impairment after correction.
  • Cannot be living in foster care.

Outcomes

Primary Outcomes

Change in baseline emotions accurately identified on the Transporters Quiz

Time Frame: 14 weeks into treatment (at completion of intervention)

The Transporters Quiz (Autism Transporters CIC, Autism Research Center) is a quiz developed to test a child's understanding of the emotions portrayed in stories. The quiz examines whether a child can link a word describing an emotion, the facial expression of that emotion, and the causes of the emotion. This quiz will be given prior to starting treatment and again at the completion of the intervention.

Secondary Outcomes

  • Change in baseline Social Responsiveness Scale Score(14 weeks into treatment (at completion of intervention))
  • Change in baseline parent report of child's emotion recognition(14 weeks into treatment (at completion of intervention))
  • Number of prompt-free intervals during the treatment sessions(Weekly throughout intervention schedule (8-14 weeks))

Study Sites (1)

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