Virtual Reality Therapy for ADHD
(VRAM Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Davis
Must not be taking: ADHD medications
Disqualifiers: Psychosis, Depression, Autism, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial uses virtual reality (VR) therapy to help children with ADHD improve their focus by getting used to distractions. The VR sessions simulate a classroom with various distractions, allowing children to practice ignoring them. The goal is to help these children perform better in real-life situations by reducing their susceptibility to distractions.
Will I have to stop taking my current medications?
If you are taking medication for ADHD, you cannot participate in certain parts of the study. The protocol does not specify about other medications, so it's best to discuss with the study team.
What data supports the effectiveness of the treatment Virtual Reality Attention Management for ADHD?
Research shows that virtual reality (VR) can help improve attention and reduce hyperactivity in children with ADHD. Studies found that VR-based interventions led to improvements in ADHD symptoms and cognitive functions like attention and memory. These findings suggest that VR therapy could be a promising tool for managing ADHD.12345
Is virtual reality therapy safe for use in humans?
How is Virtual Reality Attention Management treatment different from other ADHD treatments?
Virtual Reality Attention Management (VRAM) is unique because it uses virtual reality to create an immersive environment that mimics real-life situations, helping children with ADHD practice managing distractions in a controlled setting. This approach is different from traditional methods as it provides a more engaging and flexible way to improve attention and executive functions, which are often challenging for those with ADHD.456910
Eligibility Criteria
This trial is for children with ADHD who often get distracted, have an IQ over 80, and are comfortable using a computer. They must show signs of inattention but can't be on ADHD medication or starting other treatments during the study. Kids with severe depression, autism, psychosis, or sensory impairments that affect task performance cannot participate.Inclusion Criteria
Significant (T score >= 60) ratings of Cognitive Problems/Inattention or DSM Inattention scale scores on the Conners' Parent or Teacher Rating Scale-3 or Parent ADHD Rating Scale-IV (ADHD-RS)
Endorsement of 4 or more symptoms of inattention on a clinical psychiatric interview (e.g. Parent DISC, DICA, Kiddie-SADS, Mini-KID)
Comfortable using a computer
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Exclusion Criteria
I am not taking medication for ADHD currently.
Investigator's opinion that it is not in the subject's best interest to continue
Subject is non-compliant with training schedule
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo VR training sessions in a virtual classroom setting with adaptive or nonadaptive distractors
5-7 weeks
25 sessions (in-home)
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 weeks
Extension
Participants may continue VR training sessions to further assess long-term effects
10 weeks
Treatment Details
Interventions
- Virtual Reality Attention Management (Behavioural Intervention)
Trial OverviewThe study tests if virtual reality (VR) can help kids with ADHD focus better by getting them used to distractions in a VR classroom setting. Participants will use either a VR program designed to improve attention (treatment) or another type of VR experience (active control).
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: VR TreatmentExperimental Treatment1 Intervention
The "VR distractor condition" is an adaptive training, experimental treatment. Participants will wear a headset VR system programmed to simulate a virtual classroom. They will be asked to perform computer tests of math, attention, or working memory in the virtual reality context. Distractors will be presented intermittently throughout the test session. During training sessions, distractor saliency and frequency will increase or decrease based on performance on the tests.
25 sessions should be completed in approximately 5-7 weeks. In-home VR training sessions will each be about 20-30 minutes in length.
The investigators expect a decrease in distraction after adaptive distractor exposure in the VR classroom.
Group II: VR Active ControlActive Control1 Intervention
The "VR classroom with no distractors presented" is an active control group. This group will undergo the same training regimen, only their virtual classroom environment will not contain adaptive distractors. Participants will wear a headset VR system programmed to simulate a virtual classroom. They will be asked to perform computer tests of math, attention, or working memory in the virtual reality context.
25 sessions should be completed in approximately 5-7 weeks. In-home VR training sessions will each be about 20-30 minutes in length.
The investigators expect no change in response to distraction in the ADHD group after control exposure to the VR classroom.
Virtual Reality Attention Management is already approved in United States for the following indications:
🇺🇸 Approved in United States as Virtual Reality Attention Management for:
- Attention Deficit Hyperactivity Disorder (ADHD)
- Distractibility
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC Davis MIND InstituteSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Immersive virtual reality for improving cognitive deficits in children with ADHD: a systematic review and meta-analysis. [2023]Virtual reality (VR) shows great potential in treating and managing various mental health conditions. This includes using VR for training or rehabilitation purposes. For example, VR is being used to improve cognitive functioning (e.g. attention) among children with attention/deficit-hyperactivity disorder (ADHD). The aim of the current review and meta-analysis is to evaluate the effectiveness of immersive VR-based interventions for improving cognitive deficits in children with ADHD, to investigate potential moderators of the effect size and assess treatment adherence and safety. The meta-analysis included seven randomised controlled trials (RCTs) of children with ADHD comparing immersive VR-based interventions with controls (e.g. waiting list, medication, psychotherapy, cognitive training, neurofeedback and hemoencephalographic biofeedback) on measures of cognition. Results indicated large effect sizes in favour of VR-based interventions on outcomes of global cognitive functioning, attention, and memory. Neither intervention length nor participant age moderated the effect size of global cognitive functioning. Control group type (active vs passive control group), ADHD diagnostic status (formal vs. informal) and novelty of VR technology were not significant moderators of the effect size of global cognitive functioning. Treatment adherence was similar across groups and there were no adverse effects. Results should be cautiously interpreted given the poor quality of included studies and small sample.
Effect of Distractors on Sustained Attention and Hyperactivity in Youth With Attention Deficit Hyperactivity Disorder Using a Mobile Virtual Reality School Program. [2022]This study examined whether distractors in virtual reality (VR) environment affected the attention and hyperactivity in children and adolescents with ADHD.
The utility of a continuous performance test embedded in virtual reality in measuring ADHD-related deficits. [2015]Continuous performance tasks (CPT) are popular in the diagnostic process of Attention Deficit/Hyperactivity Disorder (ADHD), providing an objective measure of attention for a disorder with otherwise subjective criteria. Aims of the study were to: (1) compare the performance of children with ADHD on a CPT embedded within a virtual reality classroom (VR-CPT) to the currently used Test of Variables of Attention (TOVA) CPT, and (2) assess how the VR environment is experienced.
Distractibility in Attention/Deficit/ Hyperactivity Disorder (ADHD): the virtual reality classroom. [2015]Nineteen boys aged 8 to 14 with a diagnosis of ADHD and 16 age-matched controls were compared in a virtual reality (VR) classroom version of a continuous performance task (CPT), with a second standard CPT presentation using the same projection display dome system. The Virtual Classroom included simulated "real-world" auditory and visual distracters. Parent ratings of attention, hyperactivity, internalizing problems, and adaptive skills on the Behavior Assessment System for Children (BASC) Monitor for ADHD confirmed that the ADHD children had more problems in these areas than controls. The difference between the ADHD group (who performed worse) and the control group approached significance (p = .05; adjusted p = .02) in the Virtual Classroom presentation, and the classification rate of the Virtual Classroom was better than when the standard CPT was used (87.5% versus 68.8%). Children with ADHD were more affected by distractions in the VR classroom than those without ADHD. Results are discussed in relation to distractibility in ADHD.
IAmHero: Preliminary Findings of an Experimental Study to Evaluate the Statistical Significance of an Intervention for ADHD Conducted through the Use of Serious Games in Virtual Reality. [2023]The use of new technologies, such as virtual reality (VR), represents a promising strategy in the rehabilitation of subjects with attention-deficit/hyperactivity disorder (ADHD). We present the results obtained by administering the IAmHero tool through VR to a cohort of subjects with ADHD between 5 and 12 years of age. The trial time was approximately 6 months. In order to assess the beneficial effects of the treatment, standardised tests assessing both ADHD symptoms and executive functions (e.g., Conners-3 scales) were administered both before and at the end of the sessions. Improvements were observed at the end of treatment in both ADHD symptoms (especially in the hyperactivity/impulsivity domain) and executive functions. One of the strengths of the VR approach is related above all to the acceptability of this tool and its flexibility. Unfortunately, to date, there are still few studies on this topic; therefore, future studies are essential to expand our knowledge on the utility and benefits of these technologies in the rehabilitation field.
Measuring Attentional Distraction in Children With ADHD Using Virtual Reality Technology With Eye-Tracking. [2022]Label="Objective" NlmCategory="UNASSIGNED">Distractions inordinately impair attention in children with Attention-Deficit Hyperactivity Disorder (ADHD) but examining this behavior under real-life conditions poses a challenge for researchers and clinicians. Virtual reality (VR) technologies may mitigate the limitations of traditional laboratory methods by providing a more ecologically relevant experience. The use of eye-tracking measures to assess attentional functioning in a VR context in ADHD is novel. In this proof of principle project, we evaluate the temporal dynamics of distraction via eye-tracking measures in a VR classroom setting with 20 children diagnosed with ADHD between 8 and 12 years of age.
The Influence of Methylphenidate on Hyperactivity and Attention Deficits in Children With ADHD: A Virtual Classroom Test. [2020]Objective: This study compares the performance in a continuous performance test within a virtual reality classroom (CPT-VRC) between medicated children with ADHD, unmedicated children with ADHD, and healthy children. Method:N = 94 children with ADHD (n = 26 of them received methylphenidate and n = 68 were unmedicated) and n = 34 healthy children performed the CPT-VRC. Omission errors, reaction time/variability, commission errors, and body movements were assessed. Furthermore, ADHD questionnaires were administered and compared with the CPT-VRC measures. Results: The unmedicated ADHD group exhibited more omission errors and showed slower reaction times than the healthy group. Reaction time variability was higher in the unmedicated ADHD group compared with both the healthy and the medicated ADHD group. Omission errors and reaction time variability were associated with inattentiveness ratings of experimenters. Head movements were correlated with hyperactivity ratings of parents and experimenters. Conclusion: Virtual reality is a promising technology to assess ADHD symptoms in an ecologically valid environment.
Treating children's aggressive behavior problems using cognitive behavior therapy with virtual reality: A multicenter randomized controlled trial. [2023]This multicenter randomized controlled trial investigated whether interactive virtual reality enhanced effectiveness of Cognitive Behavioral Therapy (CBT) to reduce children's aggressive behavior problems. Boys with aggressive behavior problems (N = 115; Mage  = 10.58, SD = 1.48; 95.7% born in Netherlands) were randomized into three groups: CBT with virtual reality, CBT with roleplays, or care-as-usual. Bayesian analyses showed that CBT with virtual reality more likely reduced aggressive behavior compared to care-as-usual for six of seven outcomes (ds 0.19-0.95), and compared to CBT with roleplays for four outcomes (ds 0.14-0.68). Moreover, compared to roleplays, virtual reality more likely enhanced children's emotional engagement, practice immersion, and treatment appreciation. Thus, virtual reality may be a promising tool to enhance CBT effectiveness for children with aggressive behavior problems.
A controlled clinical comparison of attention performance in children with ADHD in a virtual reality classroom compared to standard neuropsychological methods. [2007]In this initial pilot study, a controlled clinical comparison was made of attention perforance in children with attention deficit-hyperactivity disorder (ADHD) in a virtual reality (VR) classroom. Ten boys diagnosed with ADHD and ten normal control boys participated in the study. Groups did not significantly differ in mean age, grade level, ethnicity, or handedness. No participants reported simulator sickness following VR exposure. Children with ADHD exhibited more omission errors, commission errors, and overall body movement than normal control children in the VR classroom. Children with ADHD were more impacted by distraction in the VR classroom. VR classroom measures were correlated with traditional ADHD assessment tools and the flatscreen CPT. Of note, the small sample size incorporated in each group and higher WISC-III scores of normal controls might have some bearing on the overall interpretation of results. These data suggested that the Virtual Classroom had good potential for controlled performance assessment within an ecologically valid environment and appeared to parse out significant effects due to the presence of distraction stimuli.
Impact of time on task on ADHD patient's performances in a virtual classroom. [2012]Use of virtual reality tool is interesting for the evaluation of Attention Deficit/Hyperactivity Disorder (ADHD) patients. The virtual environment offers the opportunity to administer controlled task like the typical neuropsychological tools, but in an environment much more like standard classroom. Previous studies showed that a virtual classroom was able to distinguish performances of children with and without ADHD, but the evolution of performances over time has not been explored. The aim of this work was to study time on task effects on performances of ADHD children compared to controls in a virtual classroom (VC).