Virtual Reality Attention Management (VRAM)

July 10, 2025 updated by: University of California, Davis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • Uc Davis Mind Institute
        • Contact:
        • Principal Investigator:
          • Julie B Schweitzer, PhD
        • Sub-Investigator:
          • Joy Geng, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR Treatment

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.
Device: VR Treatment
Distractors
Active Comparator: VR Active Control

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.
Device: VR Active Control
No distractors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in the amount of eye movements toward the distractors and/or shorter duration of fixation on distractors.
Time Frame: 5-7 weeks
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.
5-7 weeks
Decrease in the amount of head movements toward the distractors
Time Frame: 5-7 weeks
Successful decrease in head movements = improvement in extent or duration of head movements by a statistical effect size of 0.5 or greater.
5-7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement on the Restricted Academic Situations Test (RAST)
Time Frame: 5-7 weeks
Decrease in off task behavior
5-7 weeks
Improvement in CGI-S ratings in relation to distractibility
Time Frame: 5-7 weeks
CGI-S scale range: -3 (among the most extremely ill patients) to 3 (normal)
5-7 weeks
Improvement in distractibility determined by CGI-I
Time Frame: 5-7 weeks

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

Improvement = score greater than 0 post-treatment
5-7 weeks
ADHD:RS 5 - Inattentive scale
Time Frame: 5-7 weeks
Ratings of inattention
5-7 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation
Time Frame: 10 weeks
Measure participation in 70% or > in the overall number of prescribed sessions within 10 weeks.
10 weeks
Percent of children with nausea interference
Time Frame: 10 weeks
Assess if children complete 80% of the sessions without nausea interfering with performance or adherence.
10 weeks
Parent and child satisfaction
Time Frame: 10 weeks
Measure parent and child satisfaction ratings on a 7-point scale.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Julie Schweitzer, PhD, Uc Davis Mind Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2016

Primary Completion (Estimated)

September 2, 2026

Study Completion (Estimated)

July 2, 2027

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 883639
  • R61MH110043-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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