Robot-Mediated Therapy for Autism

Age: < 18

Sex: Any

Trial Phase: Academic

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

Disqualifiers: IQ <70, Head injury, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8-14 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Robot-Mediated Intervention for Autism?

Research suggests that robot-mediated interventions can help children with autism develop social skills and communication. These interventions are seen as promising and can be engaging and fun for children, although more research is needed to confirm their effectiveness. ^{1 2 3 4 5}

Is robot-mediated therapy safe for humans?

Current research on robot-mediated therapy for autism suggests it is generally safe, as studies have focused on improving social skills and attention in children with autism without reporting any significant safety concerns. ^{3 4 5 6 7}

How is Robot-Mediated Intervention different from other treatments for autism?

Robot-Mediated Intervention is unique because it uses social robots to help children with autism develop social and communication skills in a fun and engaging way, unlike traditional therapies that may not involve technology. This approach can make learning more interactive and tailored to the child's needs, potentially improving their ability to learn new skills. ^{1 2 4 5 8}

Research Team

Rebecca Landa, PhD, CCC-SLP

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

Caregivers must agree to bring their child in for pre-testing and post-testing.

My child is between 4 and 8 years old.

My child has been diagnosed with autism or PDD-NOS by both a test and a doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Families participate in the robot intervention or receive treatment as usual for 8-14 weeks

8-14 weeks

2-3 visits per week (in-person) for robot intervention group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Robot-Mediated Intervention

Trial Overview 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.

Participant Groups

Group I: Robot-mediated Intervention Experimental Treatment 1 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 Usual Active Control 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

93

Recruited

25,200+

Aetna, Inc.

Industry Sponsor

Trials

15

Recruited

6,330,000+

Findings from Research

Robot-assisted therapy (RAT) was implemented for the first time in a Chilean public health center, involving 4 children with Autism Spectrum Disorder (ASD) aged 9 to 13, and resulted in high patient adherence and satisfaction during 10 therapy sessions.

The therapy led to significant improvements in socialization behaviors and social interaction, as evidenced by video coding and the Vineland scale, indicating that RAT can effectively address core symptoms of ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic use of robotics in children with Autism Spectrum Disorder]. Yáñez, C., Madariaga, L., López, C., et al.[2022]

References

1. Chile pubmed.ncbi.nlm.nih.gov

[Therapeutic use of robotics in children with Autism Spectrum Disorder]. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Social Humanoid Robots for Children with Autism Spectrum Disorders: A Review of Modalities, Indications, and Pitfalls. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mapping Robots to Therapy and Educational Objectives for Children with Autism Spectrum Disorder. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The use of social robots with children and young people on the autism spectrum: A systematic review and meta-analysis. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The Clinical Use of Robots for Individuals with Autism Spectrum Disorders: A Critical Review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of robot-mediated interaction system on joint attention skills for children with autism. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Improving social skills in children with ASD using a long-term, in-home social robot. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Robot-mediated interventions for teaching children with ASD: A new intraverbal skill. [2022]