Virtual Reality Training for ADHD

Overseen By Clinical Research Coordinator

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: ADHD medications, Psychotropic, Neuroleptic

Disqualifiers: Drug dependence, Alcohol dependence, Head trauma, others

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

Compensation: Varies

Number of Visits: 5

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special type of driver training can help teens with ADHD (Attention-Deficit/Hyperactivity Disorder) maintain better focus on the road. The trial tests two training methods: one using a computer and driving simulator, and another using virtual reality (VR-FOCAL+). Teens with ADHD who drive at least three hours a week without supervision might be suitable for this study. The goal is to assess whether these trainings can reduce the risk of car crashes by enhancing focus while driving. As an unphased trial, this study offers teens a unique opportunity to potentially improve their driving skills and safety.

Will I have to stop taking my current medications?

If you are on ADHD medication, you may need to stop taking it on assessment days. Also, you cannot participate if you are on psychotropic or neuroleptic medications.

What prior data suggests that these driving interventions are safe for teens with ADHD?

Research has shown that the FOCAL+ training program is safe for teenagers with ADHD. Studies have found it improves focus and reduces car accidents, with no major safety issues reported.

For the Virtual Reality (VR) version of the FOCAL+ training, research is ongoing. So far, studies on VR for ADHD have not identified any serious side effects. However, some users might experience mild dizziness or nausea, which is common with VR.

Overall, both treatments appear well-tolerated, with no significant safety concerns noted in the available research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality Training for ADHD trial because it explores innovative methods to improve attention and concentration in teens with ADHD. Unlike traditional treatments, which often rely on medications like stimulants to manage symptoms, this trial leverages cutting-edge technology. The FOCAL+ training uses a desktop computer and driving simulator to enhance focus, while the VR-FOCAL+ takes it a step further by immersing participants in virtual reality, offering a more engaging and potentially more effective experience. These approaches could provide non-pharmacological alternatives that are both interactive and tailored to individual needs.

What evidence suggests that this trial's treatments could be effective for ADHD?

Research has shown that the FOCAL+ training program, available to participants in this trial, helps teens with ADHD improve their attention while driving. One study found it reduced car accidents among these teens. The program teaches drivers to focus more on the road, and past trials have demonstrated positive results.

For the Virtual Reality (VR) version of FOCAL+, another treatment option in this trial, studies indicate that VR can significantly enhance the duration of focus for teens with ADHD. Using VR might help them concentrate for longer periods. The combination of engaging VR technology and attention feedback has effectively boosted focus and alertness. These findings suggest that both FOCAL+ and VR-FOCAL+ could enhance driving safety for teens with ADHD. ^{1 3 4 5 6}

Who Is on the Research Team?

Jeff N Epstein, Ph.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for teenagers with ADHD who often face challenges while driving, such as getting distracted easily. To join, they must have a diagnosis of ADHD and be within the age range specified by the researchers.

Inclusion Criteria

Teens will meet DSM ADHD criteria for ADHD-Predominantly Inattentive Presentation or ADHD-Combined Presentation based on the K-SADS interview

IQ ≥80 as measured by the Kauffman Brief Intelligence Scale - Second Edition (KBIT-2)

I am between 16 and 19 years old.

Exclusion Criteria

I am taking medication for my mental health.

Drug or alcohol dependence based on self-report on the Simple Screening Instrument for Alcohol and Other Drugs survey

At-risk for motion sickness in the driving simulator or in virtual reality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants receive either iVR-FOCAL+, original FOCAL+, or wait-list control training

5 weeks

5 weekly sessions

Post-Training Assessment

Driving skills assessed during simulation at baseline, 1-month, and 6-months post-training

6 months

Follow-up

Naturalistic driving assessed using video event recorders for crash/near-crash events

12 months

What Are the Treatments Tested in This Trial?

Interventions

• FOCAL+
• VR-FOCAL+

Trial Overview

The study is testing two training programs designed to help teens with ADHD stay focused on the road when driving. One program uses FOCAL+, and the other adds virtual reality (VR-FOCAL+) to see if it enhances focus more effectively.

How Is the Trial Designed?

Group I: Virtual Reality - FOCAL+ Experimental Treatment 1 Intervention

Enhanced FOcused Concentration and Attention Learning driver training using virtual reality

Group II: FOCAL+ Training Experimental Treatment 1 Intervention

Enhanced FOcused Concentration and Attention Learning driver training using desktop computer and fixed base driving simulator

Group III: Wait-list Control Active Control 1 Intervention

Teens will wait approximately 1 year to receive FOCAL+ training. In order to control for experience with the driving simulator across groups, teens in this group will attend 5 weekly sessions where they will experience five 5-minute drives in the driving simulator. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Teens in this group will not receive feedback regarding eye glances during these drives.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A study involving 14 non-medicated children with ADHD showed that 18 sessions of virtual reality-enhanced treadmill training over 6 weeks led to significant improvements in social problems and psychosomatic behavior, as reported by parents.

Post-training assessments indicated enhanced executive function and memory, along with improved gait regularity during dual-task walking, suggesting that this combined motor-cognitive training could be a promising intervention for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality training to enhance behavior and cognitive function among children with attention-deficit/hyperactivity disorder: brief report. Shema-Shiratzky, S., Brozgol, M., Cornejo-Thumm, P., et al.[2019]

Game-based digital therapeutics (DTx), like EndeavorRx®, significantly improved inattention and hyperactivity/impulsivity in children with ADHD compared to control groups, based on assessments from parents and teachers.

However, traditional medication was found to be more effective than game-based DTx in reducing inattention and hyperactivity/impulsivity, indicating that while DTx offers a beneficial alternative, it may not replace conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of game-based digital therapeutics on attention deficit hyperactivity disorder in children and adolescents as assessed by parents or teachers: a systematic review and meta-analysis. Oh, S., Choi, J., Han, DH., et al.[2023]

In a study involving 20 children with ADHD, eye-tracking in a virtual reality classroom revealed that distractions significantly disrupted their ability to focus on relevant tasks, even if they did not look at the distractions for long periods.

The use of virtual reality combined with eye-tracking offers a promising method to better understand attentional impairments in real-life settings, which could help in developing more effective interventions for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Attentional Distraction in Children With ADHD Using Virtual Reality Technology With Eye-Tracking. Stokes, JD., Rizzo, A., Geng, JJ., et al.[2022]

In a study involving 36 boys aged 7 to 10, children with ADHD showed a significant decline in performance over time in a virtual classroom task, while control children maintained their performance levels.

The virtual reality environment effectively distinguished between the attentional capabilities of ADHD children and controls, correlating well with traditional measures like the Continuous Performance Test (CPT II), highlighting its potential as a reliable assessment tool for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of time on task on ADHD patient's performances in a virtual classroom. Bioulac, S., Lallemand, S., Rizzo, A., et al.[2012]

The VR continuous performance test (VR-CPT) effectively measures attention in children with ADHD and typically developing children, showing significant associations between ADHD symptoms and performance metrics like omission errors and reaction time.

Incorporating social cues, such as a virtual teacher, into the VR environment may enhance attention performance in children with ADHD, suggesting that these elements can positively influence their engagement and focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Virtual Reality Continuous Performance Test Utilizing Social Cues for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. Eom, H., Kim, KK., Lee, S., et al.[2019]

The study involved 36 boys aged 8-13 and demonstrated that a virtual reality (VR) headset was enjoyable and easy to use, indicating its potential as a tool for assessing childhood behavior problems.

Participants with more conduct problems perceived virtual characters as meaner, suggesting that VR can effectively engage children in assessing social-cognitive deficits, although it did not correlate with traditional measures of hostile attribution bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Boys' Responses to Interpersonal Conflict in Virtual Reality. Hummer, TA., Wood, ZM., Miller, K., et al.[2023]

A systematic review and meta-analysis of four studies involving 125 children with ADHD found that virtual reality-based interventions significantly improve sustained attention, with large effect sizes for omissions and correct hits.

While VR interventions showed promise in enhancing attentional vigilance, they did not lead to improvements in impulsivity, indicating that while effective for certain cognitive deficits, their impact may be limited in other areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality-Based Interventions for Children and Adolescents with ADHD: A Systematic Review and Meta-Analysis. Romero-Ayuso, D., Toledano-González, A., Rodríguez-Martínez, MDC., et al.[2021]

In a study involving 40 students (21 with ADHD and 19 controls), children with ADHD performed similarly to their peers when distractions were present in a virtual reality (VR) environment, but struggled more in a no-distractor setting.

The results suggest that children with ADHD are more sensitive to low-level stimulation, as indicated by increased head movement and poorer performance without distractions, highlighting the potential of VR as a tool for studying attention in ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Distractors on Sustained Attention and Hyperactivity in Youth With Attention Deficit Hyperactivity Disorder Using a Mobile Virtual Reality School Program. Hong, N., Kim, JJ., Kwon, JH., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10929260/

Trial of Training to Reduce Driver Inattention in Teens with ...

The Focused Concentration and Attention Learning (FOCAL) ... outcomes in novice drivers with attention deficit hyperactivity disorder (ADHD).

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02848092

NCT02848092 | Improving ADHD Teen Driving

The proposed research will test the efficacy of the FOcused Concentration and Attention Learning (FOCAL) intervention, which targets reducing the number of ...

3.

2minutemedicine.com

2minutemedicine.com/focal-training-program-reduces-the-rate-of-collisions-in-teenage-drivers-with-adhd/

FOCAL+ training program reduces the rate of collisions in ...

These results suggest that a modified FOCAL+ training program may be effective in improving attention and reducing the rate of collisions in ...

4.

nejm.org

nejm.org/doi/abs/10.1056/NEJMoa2204783

Trial of Training to Reduce Driver Inattention in Teens with ...

Participants were randomly assigned in a 1:1 ratio to undergo either enhanced Focused Concentration and Attention Learning, a program that targets reduction in ...

5.

scienceblog.cincinnatichildrens.org

scienceblog.cincinnatichildrens.org/new-driver-training-developed-at-cincinnati-childrens-keeps-teens-with-adhd-safer-behind-the-wheel/

New Driver Training Program Keeps Teens with ADHD Safer ...

The study details outcomes of the FOCALplus training program, which expands upon a desktop-based software platform called FOcused Concentration ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2214140524000124

Moderators of training response to a driver inattention ...

FOCAL+ is the only driving intervention that has been shown to be effective both at improving ADHD-related driving skills deficits and at reducing naturalistic ...