Game-Based Mobile App for Autism

Overseen By Daehyoung Lee, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Moderate-to-profound ID, Orthopedic conditions

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

75 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment PuzzleWalk for autism?

The PuzzleWalk app, designed to increase physical activity and reduce sedentary behavior, showed satisfactory usability for adults with and without autism spectrum disorder (ASD). Additionally, a gaming platform for autism intervention demonstrated improvements in concentration, flexibility, and self-esteem in children, suggesting that game-based apps can be beneficial for individuals with ASD. ^{1 2 3 4 5}

Is the PuzzleWalk app safe for use in humans?

The PuzzleWalk app was tested for usability in adults with and without autism, and the results indicated satisfactory quality, suggesting it is safe for use. However, specific safety data was not detailed, and further research is needed to confirm long-term safety. ^{1 3 6 7 8}

How is the PuzzleWalk treatment different from other autism treatments?

PuzzleWalk is unique because it uses a game-based mobile app to deliver autism intervention, focusing on improving skills like imitation and joint attention through interactive games. This approach allows for personalized, home-based therapy that involves parents and therapists, making it more accessible and adaptable compared to traditional in-person therapies. ^{1 8 9 10 11}

What is the purpose of this trial?

The clinical study aims to develop and test a gamified mobile health app called PuzzleWalk (PW) to promote physical activity (PA) and reduce sedentary behavior (SB) in autistic adults, including those with mild intellectual disabilities (ID). The study addresses the need for tailored interventions in this population, who are at higher risk for lifestyle-related chronic health conditions due to lower PA and higher SB. The upgraded version of PuzzleWalk integrates behavior change techniques and gamification strategies, such as translating step counts into puzzle game playtime, to encourage regular PA and reduce SB. The study will evaluate the app's effectiveness on preventive health behavior changes in real-world settings. The ultimate goal is to create an effective, sustainable, and scientifically validated mobile health tool to improve the health and well-being of autistic adults.

Research Team

Daehyoung Lee, PhD

Principal Investigator

University of Delaware

Eligibility Criteria

This trial is for autistic adults, including those with mild intellectual disabilities. It's designed to help participants who are at risk of health issues due to low physical activity and high sedentary behavior. The study seeks individuals willing to use a gamified mobile app aimed at increasing their daily movement.

Inclusion Criteria

Individuals who have regular access to a supported smartphone (iOS 13+ operating system)

Individuals diagnosed with an autism spectrum disorder by a medical professional or self-identify as neurodivergent

Exclusion Criteria

Individuals with a moderate-to-profound intellectual disability

I use a wheelchair or crutches due to a significant orthopedic condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 days

1 visit (in-person or virtual)

Baseline Data Collection

Participants undergo baseline data collection including demographics, technology and medication use, and accelerometer-derived PA and sedentary time

1 week

1 visit (in-person or virtual)

Intervention

Participants use the upgraded PuzzleWalk app to increase physical activity and reduce sedentary behavior, supported by periodic reminders and reinforcement messages

6 weeks

Ongoing app usage with periodic virtual check-ins

Follow-up

Participants are monitored for changes in physical activity and sedentary behavior after the intervention

1 week

1 visit (in-person or virtual)

Treatment Details

Interventions

• PuzzleWalk

Trial Overview The clinical trial is testing PuzzleWalk (PW), a game-based mobile app developed to promote physical activity and reduce time spent inactive in autistic adults. The app uses gaming elements like turning steps into puzzle playtime as motivation.

Participant Groups

Group I: PuzzleWalk (Gamified mHealth) Experimental Treatment 1 Intervention

PuzzleWalk integrates gamification strategies and incentivization of walking behaviors to induce target behavior changes. Capitalizing on the distinctive attributes and preferences of autistic adults, PW emphasizes the advantages of visual learning while minimizing the need for undesired face-to-face social interactions. A novel feature is its conversion algorithm that translates daily step counts into playtime for "spot the difference" puzzle games, which leverages the psychological satisfactions of autonomy, relatedness, and competence.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Autism Intervention Research Network on Physical Health

Collaborator

Trials

2

Recruited

80+

Findings from Research

A new automated gaming platform designed for children with autism focuses on improving key skills like Imitation and Joint Attention through engaging games, showing promise for intensive intervention in home settings.

In a 3-month trial with 10 children, parents reported improvements in their child's concentration (78%), flexibility (89%), and self-esteem (44%), indicating the platform's potential effectiveness in enhancing developmental skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. Bono, V., Narzisi, A., Jouen, AL., et al.[2020]

A systematic review of 7 randomized controlled trials involving mobile device applications for individuals with autism spectrum disorder (ASD) showed promising effects on visual and fine motor skills, with a standardized mean difference of 0.41, indicating a moderate benefit from the interventions.

While the initial results are encouraging, the authors emphasize the need for more comprehensive and larger studies to better understand the effectiveness of mobile apps in improving behavioral symptoms in individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile device applications and treatment of autism spectrum disorder: a systematic review and meta-analysis of effectiveness. Moon, SJ., Hwang, J., Hill, HS., et al.[2020]

The PuzzleWalk mobile app was found to be user-friendly and effective for promoting physical activity among both adults with and without autism spectrum disorder (ASD), based on a study involving 18 participants.

Qualitative interviews revealed important insights into the specific health and social needs of adults with ASD, highlighting areas for improvement in future iterations of the app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability inquiry of a gamified behavior change app for increasing physical activity and reducing sedentary behavior in adults with and without autism spectrum disorder. Lee, D., Frey, GC., Min, A., et al.[2021]

The systematic review analyzed 12 reviews and 43 studies from 2015 to 2020, focusing on the use of augmented reality (AR), serious games (SG), and the Picture Exchange Communication System (PECS) to engage individuals with Autism Spectrum Disorder (ASD) in behavioral therapies.

The findings highlight the need for attractive and engaging environments to improve participation in treatments for ASD, while also identifying gaps in current research and suggesting future directions for exploring these technological tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented Reality, Serious Games and Picture Exchange Communication System for People with ASD: Systematic Literature Review and Future Directions. Almurashi, H., Bouaziz, R., Alharthi, W., et al.[2022]

In a pilot study involving 11 children with autism spectrum disorder (ASD) and 19 typically developing (TD) children, actual object control skills did not improve after playing sports active video games (AVGs) for 6 sessions of 45 minutes each.

However, children with ASD showed an improvement in their perceived object control skills, suggesting that while AVGs may not enhance physical skills, they could boost confidence and motivation to engage in physical activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does playing a sports active video game improve object control skills of children with autism spectrum disorder? Edwards, J., Jeffrey, S., May, T., et al.[2022]

In a study involving 18 children and adults with autism spectrum disorders (ASD), the Empowered Brain AR smartglasses were found to be safe, with 89% of users able to wear and use the device without reporting negative effects.

Caregivers also reported no negative effects, and the majority of users and caregivers expressed satisfaction with the design, indicating that AR technology could be a beneficial tool for social communication in individuals with ASD, although further research is needed on long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Lack of Negative Effects of Wearable Augmented-Reality Social Communication Aid for Children and Adults with Autism. Sahin, NT., Keshav, NU., Salisbury, JP., et al.[2023]

The My JAKE app was successfully used by 144 caregivers of individuals with autism spectrum disorder (ASD) to log daily symptoms and behaviors over an 8- to 10-week period, showing that real-time reporting can effectively capture behavioral data.

Caregivers reported high satisfaction with the app, with over 50% expressing interest in continuing its use beyond the study, indicating that mHealth tools like My JAKE could enhance the accuracy of symptom tracking and improve the understanding of ASD interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver Daily Reporting of Symptoms in Autism Spectrum Disorder: Observational Study Using Web and Mobile Apps. Bangerter, A., Manyakov, NV., Lewin, D., et al.[2023]

Mobile apps designed for autism care can be categorized into various types, including support, educational, and data collection apps, each targeting different users such as individuals with autism, teachers, and parents.

These apps utilize innovative features like gamification and virtual reality, along with user-centered design principles, to enhance usability and effectiveness in improving autism symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Survey on Autism Care, Diagnosis, and Intervention Based on Mobile Apps Focusing on Usability and Software Design. Liu, X., Zhao, W., Qi, Q., et al.[2023]

The GOLIAH gaming platform, used alongside traditional treatment for children with autism spectrum disorder (ASD), showed improvements in joint attention and imitation skills over a 6-month period, although it did not significantly outperform standard treatment alone.

Parents reported no increase in stress levels while using GOLIAH, suggesting that the gaming intervention may be a supportive tool without adding to parental burdens, warranting further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study. Jouen, AL., Narzisi, A., Xavier, J., et al.[2020]

The smartphone-based game GuessWhat? has shown promise in distinguishing children with autism spectrum disorder (ASD) from neurotypical children, achieving a classification accuracy (AU-ROC) of 0.745 and a recall rate of 0.769 using naturalistic gameplay data.

This approach highlights the feasibility of using digital tools for screening ASD, particularly in underserved communities, suggesting that telemedicine can enhance access to early diagnosis and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine learning models using mobile game play accurately classify children with autism. Deveau, N., Washington, P., Leblanc, E., et al.[2023]

Gamification of interventions provides a promising alternative for improving social communication and cognitive skills in autistic individuals, allowing for more natural and engaging learning experiences.

This scoping review highlights the potential of game-based approaches and offers resources for parents and professionals to effectively integrate these methods into their practices for supporting autistic children, adolescents, and adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Analog and Digital Games for Autism Interventions. Atherton, G., Cross, L.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Mobile device applications and treatment of autism spectrum disorder: a systematic review and meta-analysis of effectiveness. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Usability inquiry of a gamified behavior change app for increasing physical activity and reducing sedentary behavior in adults with and without autism spectrum disorder. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Augmented Reality, Serious Games and Picture Exchange Communication System for People with ASD: Systematic Literature Review and Future Directions. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Does playing a sports active video game improve object control skills of children with autism spectrum disorder? [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Lack of Negative Effects of Wearable Augmented-Reality Social Communication Aid for Children and Adults with Autism. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Caregiver Daily Reporting of Symptoms in Autism Spectrum Disorder: Observational Study Using Web and Mobile Apps. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Survey on Autism Care, Diagnosis, and Intervention Based on Mobile Apps Focusing on Usability and Software Design. [2023]

9. England pubmed.ncbi.nlm.nih.gov

GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Machine learning models using mobile game play accurately classify children with autism. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of Analog and Digital Games for Autism Interventions. [2023]