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NCT Number: NCT03221244

Virtual Reality Attention Management

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis MIND Institute

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Joy Geng, PhD

SUB_INVESTIGATOR

Juan Ramos, BS

CONTACT

[email protected]

916 703 0294

Julie B Schweitzer, PhD

PRINCIPAL_INVESTIGATOR

Shannon Hoffman, DPT

CONTACT

[email protected]

916 703 0294

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR Treatment

Device

Distractors

VR Active Control

Device

No distractors

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Ramos

CONTACT

[email protected]

916-703-0294

Shannon Hoffman

CONTACT

[email protected]

916-703-0258

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Virtual Reality Attention Management Program for Improving Attention in Children

Acronym: VRAM

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Jul 18, 2017
Registry last updated
Jul 15, 2025

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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