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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special interactive robot can help children with autism better understand and recognize emotions during social interactions. The robot-mediated intervention involves sessions with the robot, while a control group continues their usual activities without it, to determine any differences in emotional understanding. The trial suits families with children aged 4-8 diagnosed with autism or a related developmental disorder who can communicate verbally at a basic level. Families must be prepared to participate in study activities for about three months. As an unphased trial, this study offers families a unique opportunity to contribute to groundbreaking research that could enhance emotional understanding in children with autism.

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 prior data suggests that this robot-mediated intervention is safe for children with autism?

Research shows that using robots to help children with autism is safe and well-received. Previous studies have not found any serious side effects. One study noted that robot-assisted therapy improved children's social skills without causing problems. Another study found that combining robot-assisted training with regular therapy was more effective and did not raise safety concerns.

Additionally, research indicates improvements in shared attention and behavior without negative effects. These studies suggest that using robots is safe for children with autism and offers benefits without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robot-mediated therapy for autism because it offers a novel, interactive approach that differs from traditional behavioral therapies. Unlike typical interventions, this method involves a robot that engages directly with children, providing consistent, personalized interactions that can be more engaging for kids on the autism spectrum. This approach could enhance social and emotional learning by using the robot to facilitate one-on-one sessions, potentially leading to more effective and enjoyable therapy experiences. The innovative use of technology in therapy could open new avenues for tailored interventions that address the unique needs of each child.

What evidence suggests that this robot-mediated intervention is effective for autism?

Research has shown that using robots in therapy can help children with autism improve their social skills. In this trial, some participants will receive a Robot-Mediated Intervention, involving one-on-one sessions with a robot to facilitate social interactions. Studies have found that combining robots with traditional therapy proves more effective than traditional therapy alone. Children in these programs often develop better social skills and maintain interest in the activities. Other studies suggest that these programs can positively affect how children understand and interact with emotions. Overall, using robots in therapy appears promising for helping children with autism recognize and understand emotions better. ^{1 2 3 6 7}

Who Is on the Research Team?

Rebecca Landa, PhD, CCC-SLP

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. arxiv.org arxiv.org/html/2406.10392v1

Advancing Robot-Assisted Autism Therapy: A Novel ... The results show that the autistic children from the sample documented improved performance across sessions and manifested sustained interest ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0269800

The use of social robots with children and young people on ... Robot-mediated interventions show promise in supporting the development of children on the autism spectrum.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9638397/

Effectiveness of a Robot-Assisted Psychological ... The analysis of the results showed that robot-assisted intervention could be beneficial by improving children's psychosocial skills.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946721000970

Efficacy of robot-assistive training for children with autism ... Results showed that the combination of robot-assisted training with standard therapy was more effective than the standard therapy alone, in terms of improvement ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11887874/

Qualitative outcomes and impact of a robotic intervention ... This study aimed to identify the qualitative outcomes of a robot-mediated social skills training programme for children with autism spectrum disorder.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9316169/

Social Humanoid Robots for Children with Autism ... The results have indicated that the robot-assisted therapy using KASPAR can be an effective intervention to improve the theory of mind and ...

7. mdpi.com mdpi.com/1424-8220/24/5/1503

Assisted Robots in Therapies for Children with Autism ... From this study, the conclusion is that the use of robots, in general, improves children's behaviour in the short term, but longer-term experiences are ...