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Robot-Mediated Intervention for Children With Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02617342
Recruitment Status : Active, not recruiting
First Posted : November 30, 2015
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Aetna, Inc.
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Robot-mediated Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robot-Mediated Social Skills Intervention for Children With Autism Spectrum Disorders
Study Start Date : November 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robot-mediated Intervention
Families assigned to the robot condition will be asked to complete pre-test assessments and post testing as well as to participate in the robot intervention. The intervention will last for a 8-14 week period in which families will bring their child in 2-3 times a week on average for approximately 30 minutes until 24 treatment sessions have been completed. Children will receive one-on-one intervention with an interventionist facilitating the child's interactions with the robot.
Behavioral: Robot-mediated Intervention
The intervention follows the curriculum developed by RoboKind to target and improve upon social interactions through core vocabulary and modeling.

No Intervention: Treatment as Usual
Families assigned to the TAU condition will be asked to complete pre-test assessments and approximately 8-14 weeks later return to complete post-test assessments where the social emotions activity will be retested. During the 8-14 weeks between the testing assessments, families in the TAU condition will also receive a weekly email asking about their child's media use.



Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617342


Locations
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United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Aetna, Inc.
Investigators
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Principal Investigator: Rebecca Landa, PhD, CCC-SLP Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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Responsible Party: 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.
ClinicalTrials.gov Identifier: NCT02617342    
Other Study ID Numbers: IRB00067744
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Intervention
Autism Spectrum Disorder
Social Skills
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders