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Not yet recruitingNCT07882823Updated Oct 20, 2026

Developing Virtual Reality Programs to Address Social Skills Deficits in Youth With ADHD

An interventional study of VIP Suite in Attention-Deficit/Hyperactivity Disorder (ADHD), sponsored by Indiana University. Not yet recruiting. Open to participants aged 10 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Indiana University · Not applicable, Interventional, and Other

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
10 Years to 15 Years
Sex
All
01

Study summary

Researchers at OpenMindXR, in collaboration with Indiana University, are conducting a paid research study evaluating an innovative virtual reality (VR)-based intervention designed to support social and emotional skill development in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Children with ADHD often experience challenges in social functioning, emotional regulation, and peer relationships. While behavioral therapies and school-based interventions can be effective, access, engagement, and real-world generalization of skills remain ongoing challenges. This study aims to evaluate the usability and preliminary effectiveness of VR programs for youth with ADHD.

02

Conditions studied

  • Attention-Deficit/Hyperactivity Disorder (ADHD)
03

In context

Attention Deficit Disorder with Hyperactivity

1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's planned enrollment of 48 is below the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.

Browse Indiana University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Children

  • Aged 10-15 at time of enrollment
  • Willing and able to read and understand basic instructions.
  • Meet DSM-5 Criteria for ADHD based on clinical interview
  • Willing and able, in the opinion of the investigator, to adhere to study instructions.
  • Able to complete study tasks remotely (digital device, internet connection)

Parents/Guardians

  • Must live with child participant
  • Reliable reporter of child's personality and behavior in the opinion of the investigator
  • Willing and able, in the opinion of the investigator, to supervise child's VR use
  • Willing and able, in the opinion of the investigator, to adhere to study instructions.

Exclusion criteria

Exclusion Criteria:

Children

  • Current or past bipolar disorder, any disorder involving psychosis, pervasive developmental disorders, current or past substance use disorder, or current major depressive disorder
  • Known to experience negative side effects during use of virtual reality (e.g., VR sickness)
  • In opinion of investigator, cannot complete study procedures or is inappropriate for study participation
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Experimental Arm

    Using the VR program

    Device: VIP Suite

Interventions

  • DeviceVIP Suite

    VR Program with social and emotional training for kids with ADHD

06

What researchers measure

Primary outcomes

  1. Change in Perspective Taking from Baseline to Day 30

    This measure reflects changes in scores from baseline to post-virtual reality (VR) intervention on the Perspective Taking subscale of the child Interpersonal Reactivity Index (IRI). The Perspective Taking subscale ranges from 0 to 28. The change from baseline to Day 30 is calculated as Day 30 score - Baseline score. Higher scores indicate more improved perspective taking after the VR intervention.

    Time frame: Baseline and Day 30

  2. Change in Empathic Concern from Baseline to Day 30

    This measure reflects changes in scores from baseline to post-virtual reality (VR) intervention on the Empathic Concern subscale of the child Interpersonal Reactivity Index (IRI). The Empathic Concern subscale ranges from 0 to 28. The change from baseline to Day 30 is calculated as Day 30 score - Baseline score. Higher scores indicate more improved empathy after the VR intervention.

    Time frame: Baseline and Day 30

  3. Change in Oppositional/Defiant Behavior from Baseline to Post-Treatment

    This measure reflects changes in scores on the Oppositional/Defiant subcategory of the parent Disruptive Behavior Disorder (DBD) rating scale. Scores on the scale range from 0 to 3, reflecting an average of individual items that measure the frequency of antisocial behaviors. Two scores will be calculated: Day 30 score - Baseline score and Day 60 score - Baseline score, to reflect changes from Baseline. Results will range from 0 to 3, with lower scores indicating a greater drop in oppositional and defiant behaviors.

    Time frame: Baseline, Day 30, and Day 60

  4. Overall score from Modified System Usability Scale (SUS)

    This measure reflects overall usability of the VR treatment using the Modified System Usability Scale (SUS), completed by the child. The survey has 13 questions related to the program's overall usability. Individual items range from 1-5, with a higher score indicating stronger agreement. An overall score is calculated as the sum of these items, raning from 13 to 65, with higher scores indicating greater usability of the VR program.

    Time frame: Day 30

Secondary outcomes

  1. User Burden Scale (UBS)

    Assess parent/guardian-reported ease of use and perceived burden using the User Burden Scale (UBS). The survey has 19 questions related to the program's overall usability. Individual answers are combined into a single score between 19 and 95. Higher scores indicate better usability for the program.

    Time frame: Day 30

  2. Social Skills Improvement System - Rating Scale (SSIS-RS)

    Evaluate scores at baseline and post-VR intervention on the Social Skills Improvement System - Rating Scale (SSIS-RS). The total social skills testing results range from 0-138, with a lower score indicating pro-social behavior. The total problem behavior testing results range from 0-99 with a lower score indicating pro-social behavior.

    Time frame: Baseline and Day 30

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.

Of 393 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 6 months is below that.

Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Oct 20, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
May 31, 2027
CompletionEst.
Jul 1, 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07882823
Lead sponsor
Indiana University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Zebulun M. Wood (Senior Lecturer, Indiana University) — Principal investigator
First posted
Oct 20, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
May 31, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Luke S Livingston, MS
Contact
research@openmindxr.com
+1 317-708-1934

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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