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Completed

NCT Number: NCT02617342

Robot-Mediated Intervention for Children With Autism Spectrum Disorders

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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Social Behavior Social Skills

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 2.
  • 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.

Treatment and study plan

Robot-mediated Intervention

Behavioral

The intervention follows the curriculum developed by RoboKind to target and improve upon social interactions through core vocabulary and modeling.

Primary outcomes

  1. 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

  1. Change in baseline Social Responsiveness Scale Score

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

  2. Number of prompt-free intervals during the treatment sessions

    Time frame: Weekly throughout intervention schedule (8-14 weeks)

    For treatment condition only. One session a week will be randomly selected to be recorded for 15 minutes and coded for the number of times the child independently and appropriately interacts with the robot.

  3. Change in baseline parent report of child's emotion recognition

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Aetna, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 30, 2015
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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