Robot-Mediated Intervention for Children With Autism Spectrum Disorders

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

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Robot-mediated Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02617342

IRB00067744

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Robot-mediated Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Robot-mediated Intervention

Treatment as Usual

No Intervention group

Description:

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.