VRAM: Virtual Reality Attention Management

Sponsor

University of California, Davis (Other)

Overall Status

Recruiting

CT.gov ID

NCT03221244

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

121

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD	Device: VR Treatment Device: VR Active Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant)

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.

Primary Purpose:

Treatment

Official Title:

Virtual Reality Attention Management Program for Improving Attention in Children

Actual Study Start Date :

Jun 2, 2016

Anticipated Primary Completion Date :

Jul 2, 2026

Anticipated Study Completion Date :

Jul 2, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis MIND Institute	Sacramento	California	United States	95817

Sponsors and Collaborators

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

Investigators

Principal Investigator: Julie Schweitzer, PhD, UC Davis MIND Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Learn more or sign up for the study here!

Publications

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT03221244

Other Study ID Numbers:

883639
R61MH110043-01A1

First Posted:

Jul 18, 2017

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of California, Davis

Study Results

No Results Posted as of Nov 10, 2021