Virtual Reality Attention Management

ADHD Clinical Trial

— VRAM  

Official title:

Virtual Reality Attention Management Program for Improving Attention in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221244
• Other study ID #: 883639
• Secondary ID: R61MH110043-01A1
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2016
• Est. completion date: July 2, 2026

Study information

• Verified date: April 2023
• Source: University of California, Davis
• Contact: Juan Ramos
• Phone: 916-703-0294
• Email: hs-airlab[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2, 2026
• Est. primary completion date: July 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

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

Locations

Country	Name	City	State
United States	UC Davis MIND Institute	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participation	Measure participation in 70% or > in the overall number of prescribed sessions within 10 weeks.	10 weeks
Other	Percent of children with nausea interference	Assess if children complete 80% of the sessions without nausea interfering with performance or adherence.	10 weeks
Other	Parent and child satisfaction	Measure parent and child satisfaction ratings on a 7-point scale.	10 weeks
Primary	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.	5-7 weeks
Primary	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.	5-7 weeks
Secondary	Improvement on the Restricted Academic Situations Test (RAST)	Decrease in off task behavior	5-7 weeks
Secondary	Improvement in CGI-S ratings in relation to distractibility	CGI-S scale range: -3 (among the most extremely ill patients) to 3 (normal)	5-7 weeks
Secondary	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	5-7 weeks
Secondary	ADHD:RS 5 - Inattentive scale	Ratings of inattention	5-7 weeks

External Links

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