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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly throughout intervention schedule (8-14 weeks)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in baseline emotions accurately identified on the Transporters Quiz

Secondary study objectives

Number of prompt-free intervals during the treatment sessions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met