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

Trial Summary

What is the purpose of this trial?

Teens with Attention-Deficit/Hyperactivity Disorder (ADHD) have high rates of negative driving outcomes, including motor vehicle crashes, which may be caused by visual inattention (i.e., looking away from the roadway to perform secondary tasks). Two versions of a driving intervention that trains teens to reduce instances of looking away from the roadway will be tested in teens with ADHD.

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 data supports the effectiveness of the treatment FOCAL+, VR-FOCAL+ for ADHD?

Research shows that virtual reality-based treatments can help improve attention in children with ADHD by increasing correct responses and reducing errors. These treatments create realistic environments that help children practice focusing, which can be more effective than traditional methods. ^{1 2 3 4 5}

Is virtual reality training safe for people with ADHD?

Research on virtual reality (VR) interventions for ADHD, like the Alfi program, shows that they are generally safe and well-tolerated by participants. Studies have found that VR is enjoyable and easy to use, with no significant safety concerns reported. ^{2 6 7 8 9}

How is the VR-FOCAL+ treatment for ADHD different from other treatments?

VR-FOCAL+ is unique because it uses virtual reality to combine motor and cognitive training, which involves walking on a treadmill while navigating virtual obstacles. This approach aims to improve behavior, cognitive function, and dual-tasking abilities in children with ADHD, offering a more engaging and potentially more effective alternative to traditional treatments. ^{1 2 6 10 11}

Research Team

Jeff N Epstein, Ph.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

References

1. United States 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. [2022]

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

Effectiveness of Virtual Reality-Based Interventions for Children and Adolescents with ADHD: A Systematic Review and Meta-Analysis. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Measuring Attentional Distraction in Children With ADHD Using Virtual Reality Technology With Eye-Tracking. [2022]

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

Development of Virtual Reality Continuous Performance Test Utilizing Social Cues for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Multimodal assessment of adult attention-deficit hyperactivity disorder: A controlled virtual seminar room study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Training inhibitory control in adolescents with elevated attention deficit hyperactivity disorder traits: a randomised controlled trial of the Alfi Virtual Reality programme. [2022]

7. Germany 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. [2023]

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

Assessment of Boys' Responses to Interpersonal Conflict in Virtual Reality. [2023]

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

Pharmacotherapy of pediatric attention-deficit/hyperactivity disorder. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Virtual reality training to enhance behavior and cognitive function among children with attention-deficit/hyperactivity disorder: brief report. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Impact of time on task on ADHD patient's performances in a virtual classroom. [2012]