UC Davis MIND Institute
Sacramento, California, 95817, United States
Location status: Recruiting
Location contact
Joy Geng, PhD
SUB_INVESTIGATOR
Juan Ramos, BS
CONTACT
Julie B Schweitzer, PhD
PRINCIPAL_INVESTIGATOR
Shannon Hoffman, DPT
CONTACT
NCT Number: NCT03221244
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.
Interested in participating?
Request Info8 year–12 year
All sexes
Interventional
Not applicable
Sacramento, California, 95817, United States
Location status: Recruiting
Joy Geng, PhD
SUB_INVESTIGATOR
Juan Ramos, BS
CONTACT
Julie B Schweitzer, PhD
PRINCIPAL_INVESTIGATOR
Shannon Hoffman, DPT
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Distractors
No 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.
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.
Time frame: 5-7 weeks
Decrease in off task behavior
Time frame: 5-7 weeks
CGI-S scale range: -3 (among the most extremely ill patients) to 3 (normal)
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
Time frame: 5-7 weeks
Ratings of inattention
Time frame: 10 weeks
Measure participation in 70% or > in the overall number of prescribed sessions within 10 weeks.
Time frame: 10 weeks
Assess if children complete 80% of the sessions without nausea interfering with performance or adherence.
Time frame: 10 weeks
Measure parent and child satisfaction ratings on a 7-point scale.
Contact information is provided by the study sponsor or research team.
Juan Ramos
CONTACT
Shannon Hoffman
CONTACT
University of California, Davis
Other
Virtual Reality Attention Management Program for Improving Attention in Children
Acronym: VRAM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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