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CompletedNCT02617342Updated Sep 19, 2025

Robot-Mediated Intervention for Children With Autism Spectrum Disorders

An interventional study of Robot-mediated Intervention in Autism Spectrum Disorder, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. Completed at 1 site in United States. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
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Study 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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Intervention
  • Autism Spectrum Disorder
  • Social Skills
03

In context

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's enrollment of 40 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc. is the lead sponsor of 76 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralRobot-mediated Intervention

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

06

What researchers measure

Primary outcomes

  1. Change in baseline emotions accurately identified on the Transporters Quiz

    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.

    Time frame: 14 weeks into treatment (at completion of 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

    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.

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

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

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

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Study locations

1 site
  • Kennedy Krieger Institute
    Baltimore, Maryland 21211, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02617342
Lead sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Aetna, Inc.
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.) — Principal investigator
First posted
Nov 30, 2015
Start date
Nov 2015
Primary completion
Dec 17, 2017
Completion
Feb 1, 2018
Last update
Sep 19, 2025

Study contacts

Rebecca Landa, PhD, CCC-SLP
principal investigator · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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