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Virtual Reality Attention Management (VRAM)

Primary Purpose

ADHD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR Treatment
VR Active Control
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring Distractibility, Virtual Reality, Attention, Child, Pediatric

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • UC Davis MIND InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VR Treatment

VR Active Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Improvement on the Restricted Academic Situations Test (RAST)
Decrease in off task behavior
Improvement in CGI-S ratings in relation to distractibility
CGI-S scale range: -3 (among the most extremely ill patients) to 3 (normal)
Improvement in distractibility determined by CGI-I
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
Ratings of inattention

Full Information

First Posted
July 5, 2017
Last Updated
April 16, 2023
Sponsor
University of California, Davis
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03221244
Brief Title
Virtual Reality Attention Management
Acronym
VRAM
Official Title
Virtual Reality Attention Management Program for Improving Attention in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
July 2, 2026 (Anticipated)
Study Completion Date
July 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
Distractibility, Virtual Reality, Attention, Child, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
VR Active Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VR Treatment
Intervention Description
Distractors
Intervention Type
Device
Intervention Name(s)
VR Active Control
Intervention Description
No distractors
Primary Outcome Measure Information:
Title
Decrease in the amount of eye movements toward the distractors and/or shorter duration of fixation on distractors.
Description
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.
Time Frame
5-7 weeks
Title
Decrease in the amount of head movements toward the distractors
Description
Successful decrease in head movements = improvement in extent or duration of head movements by a statistical effect size of 0.5 or greater.
Time Frame
5-7 weeks
Secondary Outcome Measure Information:
Title
Improvement on the Restricted Academic Situations Test (RAST)
Description
Decrease in off task behavior
Time Frame
5-7 weeks
Title
Improvement in CGI-S ratings in relation to distractibility
Description
CGI-S scale range: -3 (among the most extremely ill patients) to 3 (normal)
Time Frame
5-7 weeks
Title
Improvement in distractibility determined by CGI-I
Description
CGI-I scale range: -3 (very much worse) to 3 (very much improved) Improvement = score greater than 0 post-treatment
Time Frame
5-7 weeks
Title
ADHD:RS 5 - Inattentive scale
Description
Ratings of inattention
Time Frame
5-7 weeks
Other Pre-specified Outcome Measures:
Title
Participation
Description
Measure participation in 70% or > in the overall number of prescribed sessions within 10 weeks.
Time Frame
10 weeks
Title
Percent of children with nausea interference
Description
Assess if children complete 80% of the sessions without nausea interfering with performance or adherence.
Time Frame
10 weeks
Title
Parent and child satisfaction
Description
Measure parent and child satisfaction ratings on a 7-point scale.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Ramos
Phone
916-703-0294
Email
hs-airlab@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Hoffman
Phone
916-703-0258
Email
hs-airlab@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Schweitzer, PhD
Organizational Affiliation
UC Davis MIND Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis MIND Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ramos, BS
Phone
916-703-0294
Email
jframos@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Shannon Hoffman, DPT
Phone
916 703 0294
Email
hs-airlab@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Julie B Schweitzer, PhD
First Name & Middle Initial & Last Name & Degree
Joy Geng, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Virtual Reality Attention Management

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