Robot-Mediated Intervention for Children With Autism Spectrum Disorders

Robot-Mediated Social Skills 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Robot-mediated Intervention

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21211
      • Kennedy Krieger Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline Social Responsiveness Scale Score		14 weeks into treatment (at completion of intervention)
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.	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)

Collaborators and Investigators

• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Collaborators: Aetna, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 30, 2015

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Intervention; Autism Spectrum Disorder; Social Skills
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: IRB00067744