Robot-Mediated Intervention for Children With Autism Spectrum Disorders

NCT02617342 | Completed

• 1 other identifier: IRB00067744
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Intervention; Autism Spectrum Disorder; Social Skills

Outcome Measures

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.

  14 weeks into treatment (at completion of intervention)

Secondary Outcomes (3)

• Change in baseline Social Responsiveness Scale Score

  14 weeks into treatment (at completion of intervention)

• Number of prompt-free intervals during the treatment sessions

  Weekly throughout intervention schedule (8-14 weeks)

• Change in baseline parent report of child's emotion recognition

  14 weeks into treatment (at completion of intervention)

Study Arms (2)

Robot-mediated Intervention

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

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

Robot-mediated Intervention BEHAVIORAL

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

Robot-mediated Intervention

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Aetna, Inc.: collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Social Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Rebecca Landa, PhD, CCC-SLP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Autism and Related Disorders (CARD) and Professor, Johns Hopkins

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 30, 2015
• Study Start: November 1, 2015
• Primary Completion: December 17, 2017
• Study Completion: February 1, 2018
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)