Virtual Reality Attention Management

Official title

Virtual Reality Attention Management Program for Improving Attention in Children

Overview

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.

Interventions

• Device VR Treatment
  Distractors
• Device VR Active Control
  No distractors

Primary outcome measures

• Decrease in the amount of eye movements toward the distractors and/or shorter duration of fixation on distractors. [Time frame: 5-7 weeks]
• Decrease in the amount of head movements toward the distractors [Time frame: 5-7 weeks]

Secondary outcome measures (4)

• Improvement on the Restricted Academic Situations Test (RAST) [Time frame: 5-7 weeks]
• Improvement in CGI-S ratings in relation to distractibility [Time frame: 5-7 weeks]
• Improvement in distractibility determined by CGI-I [Time frame: 5-7 weeks]
• ADHD:RS 5 - Inattentive scale [Time frame: 5-7 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• UC Davis MIND Institute — Sacramento

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.
• Lalonde G, Henry M, Drouin-Germain A, Nolin P, Beauchamp MH. Assessment of executive function in adolescence: a comparison of traditional and virtual reality tools. J Neurosci Methods. 2013 Sep 30;219(1):76-82. doi: 10.1016/j.jneumeth.2013.07.005. Epub 2013 Jul 15. PMID 23867080
• Bioulac S, Lallemand S, Rizzo A, Philip P, Fabrigoule C, Bouvard MP. Impact of time on task on ADHD patient's performances in a virtual classroom. Eur J Paediatr Neurol. 2012 Sep;16(5):514-21. doi: 10.1016/j.ejpn.2012.01.006. Epub 2012 Jan 24. PMID 22269913
• Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486. PMID 24005416
• Adams R, Finn P, Moes E, Flannery K, Rizzo AS. Distractibility in Attention/Deficit/ Hyperactivity Disorder (ADHD): the virtual reality classroom. Child Neuropsychol. 2009 Mar;15(2):120-35. doi: 10.1080/09297040802169077. Epub 2008 Jun 26. PMID 18608217
• Gerardi M, Cukor J, Difede J, Rizzo A, Rothbaum BO. Virtual reality exposure therapy for post-traumatic stress disorder and other anxiety disorders. Curr Psychiatry Rep. 2010 Aug;12(4):298-305. doi: 10.1007/s11920-010-0128-4. PMID 20535592
• Goncalves R, Pedrozo AL, Coutinho ES, Figueira I, Ventura P. Efficacy of virtual reality exposure therapy in the treatment of PTSD: a systematic review. PLoS One. 2012;7(12):e48469. doi: 10.1371/journal.pone.0048469. Epub 2012 Dec 27. PMID 23300515

Identifiers

NCT: NCT03221244 · 883639 · R61MH110043-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗