Robot-Mediated Intervention for Children With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

Official title:

Robot-Mediated Social Skills Intervention for Children With Autism Spectrum Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02617342
• Other study ID #: IRB00067744
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Behavioral:
• Robot-mediated Intervention
The intervention follows the curriculum developed by RoboKind to target and improve upon social interactions through core vocabulary and modeling.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Aetna, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in baseline Social Responsiveness Scale Score		14 weeks into treatment (at completion of intervention)
Secondary	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)
Secondary	Change in baseline parent report of child's emotion recognition		14 weeks into treatment (at completion of intervention)