Attention-Deficit/Hyperactivity Disorder (ADHD)NCT07882823
Developing Virtual Reality Programs to Address Social Skills Deficits in Youth With ADHD
A study testing VIP Suite in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Indiana University.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- What is being tested?
- VIP Suite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- VIP Suite
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIP SuiteDevice
VR Program with social and emotional training for kids with ADHD
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Using the VR program Receives: Device: VIP Suite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 30
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.
Measured: Baseline and Day 30
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.
Measured: Baseline, Day 30, and Day 60
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.
Measured: Day 30
Secondary outcomes (2)
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.
Measured: Day 30
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.
Measured: Baseline and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Zebulun M. Wood, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882823
- Sponsor's protocol ID
- 25942
- Other IDs
- R43MH140643, OMX001
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes