Back to resultsRobot-Mediated Intervention for Children With Autism Spectrum Disorders
Primary Purpose
Autism Spectrum Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robot-mediated Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Intervention, Autism Spectrum Disorder, Social Skills
Eligibility Criteria
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.
Sites / Locations
- Kennedy Krieger Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Robot-mediated Intervention
Treatment as Usual
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in baseline Social Responsiveness Scale Score
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.
Change in baseline parent report of child's emotion recognition
Full Information
NCT ID
NCT02617342
First Posted
November 24, 2015
Last Updated
April 21, 2023
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Aetna, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02617342
Brief Title
Robot-Mediated Intervention for Children With Autism Spectrum Disorders
Official Title
Robot-Mediated Social Skills Intervention for Children With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Aetna, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Intervention, Autism Spectrum Disorder, Social Skills
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robot-mediated Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Robot-mediated Intervention
Intervention Description
The intervention follows the curriculum developed by RoboKind to target and improve upon social interactions through core vocabulary and modeling.
Primary Outcome Measure Information:
Title
Change in baseline emotions accurately identified on the Transporters Quiz
Description
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 Outcome Measure Information:
Title
Change in baseline Social Responsiveness Scale Score
Time Frame
14 weeks into treatment (at completion of intervention)
Title
Number of prompt-free intervals during the treatment sessions
Description
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)
Title
Change in baseline parent report of child's emotion recognition
Time Frame
14 weeks into treatment (at completion of intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Landa, PhD, CCC-SLP
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Robot-Mediated Intervention for Children With Autism Spectrum Disorders
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