Virtual Reality Attention Management

NCT03221244 | Recruiting DMC

• 2 other identifiers: 883639R61MH110043-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Distractibility; Virtual Reality; Attention; Child; Pediatric

Outcome Measures

Primary Outcomes (2)

• 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.

  5-7 weeks

• 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.

  5-7 weeks

Secondary Outcomes (4)

• Improvement on the Restricted Academic Situations Test (RAST)

  5-7 weeks

• Improvement in CGI-S ratings in relation to distractibility

  5-7 weeks

• Improvement in distractibility determined by CGI-I

  5-7 weeks

• ADHD:RS 5 - Inattentive scale

  5-7 weeks

Other Outcomes (3)

• Participation

  10 weeks

• Percent of children with nausea interference

  10 weeks

• Parent and child satisfaction

  10 weeks

Study Arms (2)

VR Treatment

EXPERIMENTAL

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

VR Active Control

ACTIVE COMPARATOR

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

Interventions

VR Treatment DEVICE

Distractors

VR Treatment

VR Active Control DEVICE

No distractors

VR Active Control

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UC Davis MIND Institute

Sacramento, California, 95817, United States

RECRUITING

Related Publications (68)

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Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Julie Schweitzer, PhD

  UC Davis MIND Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Ramos

CONTACT

916-703-0294; hs-airlab@ucdavis.edu

Shannon Hoffman

CONTACT

916-703-0258; hs-airlab@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 18, 2017
• Study Start: June 2, 2016
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): July 2, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)