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ADHDVRAMNCT03221244

Virtual Reality Attention Management

A study testing VR Treatment in people with ADHD, run by University of California, Davis at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Problems with distraction are widespread in the 21st century, but for people with developmental delays or behavioral challenges they can have more damaging effects. For example, susceptibility to distraction is associated with worse school and social performance, lower high school graduation rates, and increased… Read more about this study

Who is it for?
Ages 8 to 12 years
Conditions the study is for
ADHD
What is being tested?
VR Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
2 Jun 2016to 2 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
  • Full Scale IQ > 80

Who cannot join

  • Psychosis (by parent report at phone screen), significant depression, autism (15 or > on Social Communication Questionnaire (SCQ)), psychotic disorders, visual or hearing impairment or any other disorder that may interfere with task performance
  • It is in the investigator's opinion that it is not in the subject's best interest to continue
  • Subject is non-compliant with training schedule
  • Subjects on pharmacotherapy for ADHD at the time of enrollment will be excluded from Aims 3 and 4.
  • Subjects starting behavioral or psychological treatment for ADHD during the training phase of the study will be excluded

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • UC Davis MIND Institute

    Sacramento, California, 95817

    Juan Ramos, BS, 916-703-0294, jframos@ucdavis.edu

    Shannon Hoffman, DPT, 916 703 0294, hs-airlab@ucdavis.edu

    Recruiting

Other trials in United States

About this study

Official title: Virtual Reality Attention Management Program for Improving Attention in Children

Problems with distraction are widespread in the 21st century, but for people with developmental delays or behavioral challenges they can have more damaging effects. For example, susceptibility to distraction is associated with worse school and social performance, lower high school graduation rates, and increased incidence of serious accidents. The investigators' goal is to improve understanding of distractibility and develop a targeted treatment. The proposed intervention is based on models of habituation, which is a term that means reduced physiological and emotional response to a stimulus (e.g. moving object, or loud noise, etc.) as it is seen repeatedly. The investigators use virtual reality technology to show study participants distracting stimuli repeatedly in a virtual classroom setting, and their hypothesis states that participants will improve attention in the face of distraction by training with this technology intervention. The virtual classroom setting is especially relevant for children who have significant challenges with distractibility, such as children with ADHD. This intervention will likely be effective in helping individuals with other clinical disorders and perhaps the general population as well.

Read the detailed description

Distraction is a growing and large public health problem with estimated societal harm due to distracted driving alone at $123 billion. In the age of texting, social media and computer pop-ups, distractions are unavoidable. There are no known interventions specifically developed to reduce distractions from interfering with attention. This project will test a treatment that combines virtual reality (VR) technology with habituation learning and exposure therapy to reduce the ability of distractors to interfere with learning and attention in children who are highly susceptible to being distracted. The investigators will test the treatment in children with symptoms of attention-deficit/hyperactivity disorder (ADHD) as they represent an enriched sample experiencing impairing distractibility that interferes with their daily functioning. The investigators hypothesize that children who suffer from severe distractibility can learn to ignore the distractors and improve their attention in VR therapy that simulates environments requiring focused attention. The neural targets of the therapy are both proactive and reactive control mechanisms used to suppress distractor processing. The investigators will assess how well VR therapy is at modulating distractor suppression via saccade metrics and measure the frequency of oculomotor capture by distractors as well as the efficiency of distractor suppression before and after therapy. Changes in head movement toward distractors, parent and teacher ADHD rating scales and improved performance on attention-demanding tasks will further assess success of the therapy and its ability to generalize to novel environments. Children will practice computer exercises at home using a VR headset that simulates a classroom environment with a high rate of distractors. Children will be performing attention-demanding tasks as if they were in a classroom with the intensity and rate of presentation of the personalized distractions (e.g., peers talking, teacher walking by) adapted according to the child's performance. With today's low-cost VR-gaming technology, children will be able to participate in habituation treatment sessions at-home, several times a week, using a lightweight and comfortable VR gaming headset.

In this "fast fail" test of the VR therapy, the project will assess the preliminary success and feasibility of VR training to modify saccades to distractors in an adaptive training versus nonadaptive training scenario. Data from this trial will determine whether to go forward for a subsequent confirmatory study.

Conditions
ADHD
Being tested
VR Treatment, VR Active Control
Keywords
Distractibility, Virtual Reality, Attention, Child, Pediatric
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR TreatmentDevice

    Distractors

  • VR Active ControlDevice

    No distractors

Study groups in NCT03221244
Study groupRoleWhat they receive
VR TreatmentExperimentalThe "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.
Receives: Device: VR Treatment
VR Active ControlActive comparatorThe "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.
Receives: Device: VR Active Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in the amount of eye movements toward the distractors and/or shorter duration of fixation on distractors.

    Successful distractor suppression = improvement in number of orienting eye saccades toward distractors and duration of fixations by a statistical effect size of 0.5 or greater.

    Measured: 5-7 weeks

  2. Decrease in the amount of head movements toward the distractors

    Successful decrease in head movements = improvement in extent or duration of head movements by a statistical effect size of 0.5 or greater.

    Measured: 5-7 weeks

Secondary outcomes (4)
  1. Improvement on the Restricted Academic Situations Test (RAST)

    Decrease in off task behavior

    Measured: 5-7 weeks

  2. Improvement in CGI-S ratings in relation to distractibility

    CGI-S scale range: -3 (among the most extremely ill patients) to 3 (normal)

    Measured: 5-7 weeks

  3. Improvement in distractibility determined by CGI-I

    CGI-I scale range: -3 (very much worse) to 3 (very much improved)

    Improvement = score greater than 0 post-treatment

    Measured: 5-7 weeks

  4. ADHD:RS 5 - Inattentive scale

    Ratings of inattention

    Measured: 5-7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start2 Jun 2016
  3. Primary completion2 Sep 2027 (estimated)
  4. Study completion2 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to one of two groups. Group 1: the treatment arm is the "VR Treatment" which presents distractors with increasing intensity as performance on attention measures improves. Group 2: in this active control arm ("VR Active Control") participants interact with the VR classroom with no distractors presented.
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03221244
Sponsor's protocol ID
883639
Other IDs
R61MH110043-01A1
Acronym
VRAM
Status last verified
Oct 2026
First submitted
5 Jul 2017
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • The Economic and Societal Impact of motor Vehicle Crashes. NHTSA; 2015.

  • Barkley RA, ed Attention deficit hyperactivity disorder: A handbook for diagnosis and treatment. 4th ed. New York: Guilford; 2015.

  • Lalonde G, Henry M, Drouin-Germain A, Nolin P, Beauchamp MH. Assessment of executive function in adolescence: a comparison of traditional and virtual reality tools. J Neurosci Methods. 2013 Sep 30;219(1):76-82. doi: 10.1016/j.jneumeth.2013.07.005. Epub 2013 Jul 15.

    PubMed 23867080
  • Bioulac S, Lallemand S, Rizzo A, Philip P, Fabrigoule C, Bouvard MP. Impact of time on task on ADHD patient's performances in a virtual classroom. Eur J Paediatr Neurol. 2012 Sep;16(5):514-21. doi: 10.1016/j.ejpn.2012.01.006. Epub 2012 Jan 24.

    PubMed 22269913
  • Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.

    PubMed 24005416
  • Adams R, Finn P, Moes E, Flannery K, Rizzo AS. Distractibility in Attention/Deficit/ Hyperactivity Disorder (ADHD): the virtual reality classroom. Child Neuropsychol. 2009 Mar;15(2):120-35. doi: 10.1080/09297040802169077. Epub 2008 Jun 26.

    PubMed 18608217
  • Gerardi M, Cukor J, Difede J, Rizzo A, Rothbaum BO. Virtual reality exposure therapy for post-traumatic stress disorder and other anxiety disorders. Curr Psychiatry Rep. 2010 Aug;12(4):298-305. doi: 10.1007/s11920-010-0128-4.

    PubMed 20535592
  • Goncalves R, Pedrozo AL, Coutinho ES, Figueira I, Ventura P. Efficacy of virtual reality exposure therapy in the treatment of PTSD: a systematic review. PLoS One. 2012;7(12):e48469. doi: 10.1371/journal.pone.0048469. Epub 2012 Dec 27.

    PubMed 23300515
  • Parsons TD, Rizzo AA. Affective outcomes of virtual reality exposure therapy for anxiety and specific phobias: a meta-analysis. J Behav Ther Exp Psychiatry. 2008 Sep;39(3):250-61. doi: 10.1016/j.jbtep.2007.07.007. Epub 2007 Jul 25.

    PubMed 17720136
  • Powers MB, Emmelkamp PM. Virtual reality exposure therapy for anxiety disorders: A meta-analysis. J Anxiety Disord. 2008;22(3):561-9. doi: 10.1016/j.janxdis.2007.04.006. Epub 2007 Apr 27.

    PubMed 17544252
  • Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.

    PubMed 11587113
  • Lange B, Koenig S, Chang CY, McConnell E, Suma E, Bolas M, Rizzo A. Designing informed game-based rehabilitation tasks leveraging advances in virtual reality. Disabil Rehabil. 2012;34(22):1863-70. doi: 10.3109/09638288.2012.670029. Epub 2012 Apr 12.

    PubMed 22494437
  • Maskey M, Lowry J, Rodgers J, McConachie H, Parr JR. Reducing specific phobia/fear in young people with autism spectrum disorders (ASDs) through a virtual reality environment intervention. PLoS One. 2014 Jul 2;9(7):e100374. doi: 10.1371/journal.pone.0100374. eCollection 2014.

    PubMed 24987957
  • Salem Y, Elokda A. Use of virtual reality gaming systems for children who are critically ill. J Pediatr Rehabil Med. 2014;7(3):273-6. doi: 10.3233/PRM-140296.

    PubMed 25260510
  • Wang M, Reid D. Virtual reality in pediatric neurorehabilitation: attention deficit hyperactivity disorder, autism and cerebral palsy. Neuroepidemiology. 2011;36(1):2-18. doi: 10.1159/000320847. Epub 2010 Nov 17.

    PubMed 21088430

Questions about this trial

What is this clinical trial studying?

A study testing VR Treatment in people with ADHD, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juan Ramos (916-703-0294, hs-airlab@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in the amount of eye movements toward the distractors and/or shorter duration of fixation on distractors. (time frame: 5-7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03221244, which also lists 68 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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Virtual Reality Attention Management (NCT03221244) | AzTrials