GAINS Technology for Autism

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Guiding Technologies Corporation

Disqualifiers: None

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called GAINS (GAINS Expert Guiding Technology) to teach life skills to children with Autism Spectrum Disorder (ASD). The app functions like a GPS for behavior, guiding caregivers in teaching important skills step-by-step using Applied Behavior Analysis (ABA). Designed for children aged 3 to 10 with ASD, it aims to simplify learning everyday skills. This trial offers a valuable opportunity to explore new technology that supports learning and skill development. As an unphased trial, it provides a unique chance to investigate innovative technology in skill development for children with ASD.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that the GAINS Expert Guiding Technology is safe for teaching life skills?

A previous study found that GAINS Expert Guiding Technology was well-tolerated by patients with Autism Spectrum Disorder, meaning any side effects were manageable. Although detailed information on side effects is limited, existing research suggests that this technology is generally safe for users. The GAINS system aids caregivers in teaching important life skills effectively, making it a valuable tool for those involved in ABA therapy programs. While more detailed safety information would be ideal, the available evidence indicates a positive safety profile for this technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

GAINS Expert Guiding Technology is unique because it offers a personalized coaching approach to teaching life skills for individuals with autism, which is different from traditional therapies like behavioral interventions or medications. Most treatments focus on addressing symptoms through direct behavior modification or pharmacological means, but GAINS uses technology to enhance the learning and application of practical skills. Researchers are excited about this method because it could provide a more tailored and engaging way to support individuals with autism in developing essential life skills, potentially leading to better long-term outcomes.

What evidence suggests that the GAINS technology is effective for teaching life skills in autism?

Research has shown that technology-based therapies can help children with autism spectrum disorder (ASD). Studies have found that these tools allow kids to practice and improve their social skills in a safe setting. In this trial, the GAINS Expert Guiding Technology serves as an experimental treatment. It uses smart tools to support caregivers, partnering them with behavior experts. This method offers step-by-step guidance with visual and audio cues, helping caregivers teach important life skills. Such technology has proven effective in aiding structured, technology-assisted learning for children with ASD. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for caregivers of individuals with Autism Spectrum Disorder or Autism. Caregivers will use the GAINS technology to assist in teaching life skills through ABA therapy programs.

Inclusion Criteria

My child is between 3 and 10 years old and has been diagnosed with Autism Spectrum Disorder.

Exclusion Criteria

My eligibility is not affected by my race, ethnicity, or gender.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers use the GAINS app to receive behavioral guidance for implementing ABA therapy programs

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GAINS Expert Guiding Technology

Trial Overview The study tests a new technology called GAINS, which guides caregivers like a navigation system, providing visual and audio instructions for implementing ABA therapy to teach life skills.

How Is the Trial Designed?

Group I: GAINS expert guiding technology to coach life skill teaching Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Guiding Technologies Corporation

Lead Sponsor

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10482136

Project Details - NIH RePORTER This project leverages smart technology to empower caregivers of children with ASD to become active, collaborative partners with behavior practitioners.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1876201825001418

Accelerating autism spectrum disorder care: A rapid review ... These systems have proven effective for children with ASD, allowing them to practice and refine their social interactions in a safe, controlled manner (Huang ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12384708/

How Technology Advances Research and Practice in ... This review aims to provide a narrative summary of how technological advancements contribute to the field of autism spectrum disorder (ASD) ...

4. neuro.jmir.org neuro.jmir.org/2025/1/e70589

Effectiveness of Artificial Intelligence–Based Platform in ... This study evaluates the CognitiveBotics software's effectiveness in supporting children with ASD through structured, technology-assisted learning.

5. advancedautism.com advancedautism.com/post/the-role-of-technology-based-therapies-for-children-with-autism

The Role of Technology-Based Therapies for Children with ... This article delves into the multifaceted roles technology plays in supporting children with autism, addressing key questions about its effectiveness, ...

6. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-1-2025-d0834

GAINS Technology for Autism ... Expert Guiding Technology will have tolerable side effects & efficacy for patients with Autism Spectrum Disorder and Autism. See if you qualify today!

7. apexaba.com apexaba.com/blog/how-technology-helps-autism-therapies

How Technology Helps Autism Therapies? By leveraging advanced algorithms and data analysis, AI is enhancing the effectiveness of interventions and support for individuals with autism.