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Robotics

Robot-Mediated Therapy for Autism

N/A
Waitlist Available
Led By Rebecca Landa, PhD, CCC-SLP
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly throughout intervention schedule (8-14 weeks)
Awards & highlights

Study Summary

This trial is testing whether an interactive, social robotics program can help children with ASD understand emotions and interact better with others. Families will be assigned at random to either the robot intervention or no intervention, and children will be assessed before and after the 8-14 week trial period.

Who is the study for?
This trial is for children aged 4 to nearly 9 with Autism Spectrum Disorders (ASD) who can speak enough to do a Module 2 ADOS-2 test. They need a clinical ASD or autism diagnosis and their caregivers must commit to the study duration and testing schedule. Families should primarily speak English at home.Check my eligibility
What is being tested?
The study tests an interactive robot program designed to help kids with ASD understand and recognize emotions better. It involves random assignment of participants into two groups: one using the robot intervention, and another without any new intervention, over an 8-14 week period.See study design
What are the potential side effects?
Since this is a behavioral intervention involving robots, there are no direct medical side effects like you'd expect from medication. However, it's important to monitor how each child reacts emotionally or behaviorally to the interaction with the robot.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 4 and 8 years old.
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My child has been diagnosed with autism or PDD-NOS by both a test and a doctor.
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My family speaks English at least half the time at home.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly throughout intervention schedule (8-14 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly throughout intervention schedule (8-14 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in baseline emotions accurately identified on the Transporters Quiz
Secondary outcome measures
Change in baseline Social Responsiveness Scale Score
Change in baseline parent report of child's emotion recognition
Number of prompt-free intervals during the treatment sessions

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Robot-mediated InterventionExperimental Treatment1 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.
Group II: Treatment as UsualActive Control1 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.

Find a Location

Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
88 Previous Clinical Trials
24,898 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
3,439 Patients Enrolled for Autism Spectrum Disorder
Aetna, Inc.Industry Sponsor
14 Previous Clinical Trials
6,330,032 Total Patients Enrolled
Rebecca Landa, PhD, CCC-SLPPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
7 Previous Clinical Trials
1,163 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
1,163 Patients Enrolled for Autism Spectrum Disorder

Media Library

Robot-Mediated Intervention (Robotics) Clinical Trial Eligibility Overview. Trial Name: NCT02617342 — N/A
Autism Spectrum Disorder Research Study Groups: Treatment as Usual, Robot-mediated Intervention
Autism Spectrum Disorder Clinical Trial 2023: Robot-Mediated Intervention Highlights & Side Effects. Trial Name: NCT02617342 — N/A
Robot-Mediated Intervention (Robotics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02617342 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility requirements for participating in this clinical experiment?

"To qualify for this study, individuals must have a diagnosis of autism spectrum disorder and be aged between 4-8 years old. The goal is to recruit 40 volunteers in total."

Answered by AI

Does this research project currently welcome participants?

"According to clinicaltrials.gov, the trial has not been actively recruiting since March of 2022 and is no longer seeking patients at this time. The initial posting was made on November 1st 2015; however, 1132 other trials are currently in search of participants."

Answered by AI

Are individuals 55 years or greater eligible for this research project?

"As indicated by the requirements, this clinical trial is open to all children between 4 and 8 years old. For younger age brackets (under 18) there are 422 trials while 651 exist for those over 65."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
< 18
18 - 65
What site did they apply to?
Kennedy Krieger Institute
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Mar 2025