Virtual Reality Attention Management

ConditionADHD

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age8-12

SponsorUniversity of California, Davis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

VR Treatment
Device
Distractors
VR Active Control
Device
No distractors

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: VR TreatmentExperimental treatment 1 intervention

Group B: VR Active ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

5-7 weeks

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.

Time frame

5-7 weeks

Secondary outcomes

Improvement on the Restricted Academic Situations Test (RAST)

Decrease in off task behavior

Time frame

5-7 weeks

Improvement in CGI-S ratings in relation to distractibility

CGI-S scale range: -3 (among the most extremely ill patients) to 3 (normal)

Time frame

5-7 weeks

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

Time frame

5-7 weeks

ADHD:RS 5 - Inattentive scale

Ratings of inattention

Time frame

5-7 weeks

Other outcomes

Participation

Measure participation in 70% or \> in the overall number of prescribed sessions within 10 weeks.

Time frame

10 weeks

Percent of children with nausea interference

Assess if children complete 80% of the sessions without nausea interfering with performance or adherence.

Time frame

10 weeks

Parent and child satisfaction

Measure parent and child satisfaction ratings on a 7-point scale.

Time frame

10 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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