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Virtual Reality Attention Management

Virtual Reality Attention Management Program for Improving Attention in Children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03221244
Acronym
VRAM
Enrollment
50
Registered
2017-07-18
Start date
2016-06-02
Completion date
2027-07-02
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

Distractibility, Virtual Reality, Attention, Child, Pediatric

Brief 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 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.

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.

Interventions

DEVICEVR Treatment

Distractors

DEVICEVR Active Control

No distractors

Sponsors

University of California, Davis
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will not be told in detail about the specific differences between the "VR Treatment" and the "VR Active Control." Therefore participants will not know which VR condition they received.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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 * Full Scale IQ \> 80

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Decrease in the amount of eye movements toward the distractors and/or shorter duration of fixation on distractors.5-7 weeksSuccessful 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.
Decrease in the amount of head movements toward the distractors5-7 weeksSuccessful decrease in head movements = improvement in extent or duration of head movements by a statistical effect size of 0.5 or greater.

Secondary

MeasureTime frameDescription
Improvement on the Restricted Academic Situations Test (RAST)5-7 weeksDecrease in off task behavior
Improvement in CGI-S ratings in relation to distractibility5-7 weeksCGI-S scale range: -3 (among the most extremely ill patients) to 3 (normal)
Improvement in distractibility determined by CGI-I5-7 weeksCGI-I scale range: -3 (very much worse) to 3 (very much improved) Improvement = score greater than 0 post-treatment
ADHD:RS 5 - Inattentive scale5-7 weeksRatings of inattention

Countries

United States

Contacts

CONTACTJuan Ramos
hs-airlab@ucdavis.edu916-703-0294
CONTACTShannon Hoffman
hs-airlab@ucdavis.edu916-703-0258
PRINCIPAL_INVESTIGATORJulie Schweitzer, PhD

UC Davis MIND Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026