Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Reality Attention Management (VRAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03221244
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis

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 Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : June 2, 2016
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Improvement on the Restricted Academic Situations Test (RAST) [ Time Frame: 5-7 weeks ]
    Decrease in off task behavior

  2. 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)

  3. 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


  4. ADHD:RS 5 - Inattentive scale [ Time Frame: 5-7 weeks ]
    Ratings of inattention


Other Outcome Measures:
  1. Participation [ Time Frame: 10 weeks ]
    Measure participation in 70% or > in the overall number of prescribed sessions within 10 weeks.

  2. 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.

  3. Parent and child satisfaction [ Time Frame: 10 weeks ]
    Measure parent and child satisfaction ratings on a 7-point scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221244


Contacts
Layout table for location contacts
Contact: Juan Ramos 916-703-0294 hs-airlab@ucdavis.edu
Contact: Shannon Hoffman 916-703-0258 hs-airlab@ucdavis.edu

Locations
Layout table for location information
United States, California
UC Davis MIND Institute Recruiting
Sacramento, California, United States, 95817
Contact: Juan Ramos, BS    916-703-0294    jframos@ucdavis.edu   
Contact: Shannon Hoffman, DPT    916 703 0294    hs-airlab@ucdavis.edu   
Principal Investigator: Julie B Schweitzer, PhD         
Sub-Investigator: Joy Geng, PhD         
Sponsors and Collaborators
University of California, Davis
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Julie Schweitzer, PhD UC Davis MIND Institute

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.
Hoza B. Johnston C, Pillow DR, Ascough JC. Predicting treatment response for childhood attention-deficit/hyperactivity : Introduction of a heuristic model to guide research. Appl Prev Psychol. 12// 2006; 11(4):215-229
Rizzo AS, Buckwalter JG, Forbell E, et al. Virtual Reality Appliances to Address the Wounds of War. Psychiatric Annals. 2013;43(3):123-138.
Adams R, Finn P, Flannery K, Moes E,, Matano B, Rizzo A. A virtual reality ADD classroom and the BASC: A preliminary investigation of convergent validity. J Int Neuropsychol Soc. 2005;11(S1):151.
Geng JJ. Attentional Mechanisms of Distractor Suppression. Current direction in psychological science. 2014;23(2):147-153.
DuPaul G, Rapport MD, Perriello LM. The development of the academic performance rating scale. School Psychol Rev. 1990;20:284-300.
Barkley RA. Attention deficit hyperactivity disorder: A handbook for diagnosis and treatment. 3rd ed. New York: Guilford Press; 2006.

Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03221244     History of Changes
Other Study ID Numbers: 883639
R61MH110043-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
Distractibility
Virtual Reality
Attention
Child
Pediatric