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Virtual Reality Treatment for Emerging Adults With ADHD

Development of a Novel Virtual Reality Treatment for Emerging Adults With ADHD

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06454604
Enrollment
60
Registered
2024-06-12
Start date
2024-09-20
Completion date
2025-07-30
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, Virtual reality

Brief summary

The goal of this pilot randomized clinical trial is to test the impact of a virtual reality program for improving the ability of emerging adults (age 18-25) with attention deficit hyperactivity disorder (ADHD) to stay focused while completing homework and studying. This study compares the impact of using a virtual reality headset to using a virtual reality headset while also receiving feedback about levels of focus to a control group. The main question is whether participants demonstrate significantly improved concentration while completing homework and studying in virtual reality and whether they enjoy and prefer working in a virtual reality environment. Concentration is measured both through participant report and also using keyboard and mouse click data to assess work productivity objectively.

Detailed description

This study involves a pilot randomized control trial (RCT) to assess the feasibility/usability and preliminary effects of a virtual reality (VR) environment alone (n=15) compared to VR environment + feedback about focus (n=15) and to a VR passthrough control (n=15). Proposed mechanisms of action will be measured every session, including data on keyboard and mouse clicks plus self-ratings of concentration, homework effort, and homework motivation. After completing the initial diagnostic evaluation and confirming eligibility, 45 emerging adults with ADHD (ages 18-25) will be randomized to 1 of 3 groups and then provided with a VR headset and computer to use in their dorm/home. Randomization will be performed (1:1:1) to the three conditions. Randomization will be blocked on ADHD medication status to ensure an equal number of participants taking and not taking ADHD medication in each group. Phase 3 includes a 2-session baseline where all participants complete homework and study without using the VR headset. Group 1, VR passthrough: After completing the two session baseline, participants will use the VR headset in their room/home or the library 10 times over two weeks (max twice a day with a minimum 2-hour break) for 1-hour sessions each time. The participant will wear the headset, but it will not be used as usual. The headset will be in VR passthrough mode, meaning the participant will see through to the normal environment and laptop (i.e., they can see the real world around them, just wearing a headset). Group 2, VR environment only: After completing the two session baseline, participants will use the VR headset in their room/home or the library 10 times over two weeks (max twice a day with a minimum 2-hour break) for 1-hour sessions each time. For the following sessions, the participant will wear the VR headset and engage in homework in the VR environment. Group 2, VR environment + feedback: After completing the two session baseline, participants will use the VR headset in their room/home or the 10 times over two weeks (max twice a day with a minimum 2-hour break) for 1-hour sessions each time. For the following sessions, the participant will wear the VR headset and engage in homework in the VR environment while receiving real time visual feedback on performance and focus. Participants concentration, effort/efficiency, and motivation is assessed each baseline and VR session, and participants answer questions about VR feasibility, useability, and acceptability.

Interventions

Wearing the headset and headphones removes all outside audio and visual distractions. One of the groups receives frequent and consistent feedback about work productivity similar to behavioral interventions for ADHD.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Louisiana State University Health Sciences Center in New Orleans
CollaboratorOTHER
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Parallel group randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* To be included, participants must meet DSM-5 criteria for ADHD and be between the ages of 18 and 25. Given high rates of comorbidities in college students with ADHD, participants who meet criteria for ODD, anxiety or depressive disorders on the diagnostic interview are not excluded. In addition, participants must have an item mean score of \>2.0 (often or very often) on the homework task specific version of the Adult Concentration Index (ACI), ensuring the presence of a problem in the mechanism being targeted in this study. The participant has to endorse a total of at least 5 symptoms in the ADHD inattention domain as currently present and impairing and at least 6 symptoms in the ADHD inattention domain as present and impairing during childhood. To rule out exclusionary conditions and/or to assess for the presence of comorbid conditions, psychological functioning will be assessed using the DSM-5 version of the Structured Clinical Interview for DSM Disorders (SCID-5-RV)

Exclusion criteria

* Whether primary or not, the comorbid presence of several other conditions will be exclusionary. This includes autism spectrum disorders, bipolar disorder, obsessive-compulsive disorder, active substance abuse, and other psychiatric conditions whose treatment precludes participation in the study. Students who do not meet criteria for ADHD or who are not in the specified age range are also not eligible to participate. Students with a history of seizures are not eligible to participate given the use of VR.

Design outcomes

Primary

MeasureTime frameDescription
Objective On-Task Assessment AlgorithmParticipants had 2 weeks to complete sessions 1-7 and a 3rd week to complete the last 5 sessions, equaling 12 sessions within 3 weeks.Percentage of time on-task during each study session utilizing the Objective On-Task Assessment algorithmic mouse and keyboard click data. There are no subscales in this measure. Percentages below are for sessions 1-2 (T1) and 3-12 (T2). Participants had 2 weeks to complete sessions 1-7 and a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation/motivational purposes (payment after sessions 1-7 and after 8-12) and were not outcome measurement time points. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions, which we considered 'baseline,' giving us a base focus score before participants put on a headset. Participants wore the headsets for sessions 3-12. Percentages below were averaged for each time point. T1 is an average of session 1+2's percentages. T2 is an average of sessions 3-12's percentages.
Homework Concentration IndexParticipants had 2 weeks to complete sessions 1-7, a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks.The 1-7 and 8-12 time points were only for compensation purposes and were not outcome measure points.This measure looks at how concentrated participants were while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True. There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = worse concentration. The total score is summed. Numbers below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below were averaged for T1 (Sessions 1+2) and T2 (Sessions 3-12).

Secondary

MeasureTime frameDescription
Homework Effort IndexParticipants had 2 weeks to complete sessions 1-7, a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation purposes and were not outcome measure points.The Homework Effort Index looks at how much effort participants were able to put in while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True. There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = greater levels of effort. The total score is summed. Scores below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below are averaged for T1 and T2.
Homework Motivation IndexParticipants had 2 weeks to complete sessions 1-7, a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation purposes and were not outcome measure points.The Homework Motivation Index measures how motivated participants were while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True.There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = greater levels of motivation. The total score is summed. Scores below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below were averaged for T1 and T2.

Countries

United States

Participant flow

Pre-assignment details

We ask the participants their current ADHD medication status because we block randomize based on if they are taking medication or not, to ensure groups are well-balanced between taking medication and not taking medication.

Participants by arm

ArmCount
VR Passthrough
Participants in this condition wear the same VR headset as participants in the in the other arms. However, they see directly through to their laptop and are not emersed in the virtual world. Meta Quest 3 VR Headset with noise cancelling headphones: Wearing the headset and headphones removes all outside audio and visual distractions. One of the groups receives frequent and consistent feedback about work productivity similar to behavioral interventions for ADHD.
22
Virtual Reality
Participants in this condition wear the virtual reality headset. They are emersed in a virtual world that looks like a cabin room with windows. They are sitting at a desk and can see their laptop screen as part of the virtual world. Meta Quest 3 VR Headset with noise cancelling headphones: Wearing the headset and headphones removes all outside audio and visual distractions. One of the groups receives frequent and consistent feedback about work productivity similar to behavioral interventions for ADHD.
18
Virtual Reality + Feedback
Participants in this condition wear the virtual reality headset. They are emersed in a virtual world that looks like a cabin room with windows. They are sitting at a desk and can see their laptop screen as part of the virtual world. The program tracks their keyboard and mouse click data to assess how consistently they are working. A stoplight in the virtual environment is green when they are working consistently and turns red when the not. Meta Quest 3 VR Headset with noise cancelling headphones: Wearing the headset and headphones removes all outside audio and visual distractions. One of the groups receives frequent and consistent feedback about work productivity similar to behavioral interventions for ADHD.
20
Total60

Baseline characteristics

CharacteristicTotalVR PassthroughVirtual RealityVirtual Reality + Feedback
Adult Concentration Index (ACI)
ACI Symptom Count
6.07 units on a scale
STANDARD_DEVIATION 1.07
5.91 units on a scale
STANDARD_DEVIATION 1.06
5.94 units on a scale
STANDARD_DEVIATION 1.3
6.35 units on a scale
STANDARD_DEVIATION 0.81
Adult Concentration Index (ACI)
ACI Total Score
16.75 units on a scale
STANDARD_DEVIATION 3.22
16.05 units on a scale
STANDARD_DEVIATION 3.09
16.61 units on a scale
STANDARD_DEVIATION 3.76
17.65 units on a scale
STANDARD_DEVIATION 2.74
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
60 Participants22 Participants18 Participants20 Participants
Barkley Deficits in Executive Functioning Scale (BDEFS-Short Form)
BDEFs Symptom Count
17.40 units on a scale
STANDARD_DEVIATION 2.64
17.55 units on a scale
STANDARD_DEVIATION 2.69
17.28 units on a scale
STANDARD_DEVIATION 3.01
17.35 units on a scale
STANDARD_DEVIATION 2.37
Barkley Deficits in Executive Functioning Scale (BDEFS-Short Form)
BDEFs Total Rating Score
55.20 units on a scale
STANDARD_DEVIATION 10.7
53.82 units on a scale
STANDARD_DEVIATION 7.63
55.67 units on a scale
STANDARD_DEVIATION 13.5
56.3 units on a scale
STANDARD_DEVIATION 11.15
Barkley Functional Impairment Scale (BFIS)4.66 scores on a scale
STANDARD_DEVIATION 1.74
4.91 scores on a scale
STANDARD_DEVIATION 1.52
4.62 scores on a scale
STANDARD_DEVIATION 1.75
4.42 scores on a scale
STANDARD_DEVIATION 2
Baseline Homework Effort Index16.48 units on a scale
STANDARD_DEVIATION 4.27
17.09 units on a scale
STANDARD_DEVIATION 3.83
16.50 units on a scale
STANDARD_DEVIATION 4.62
15.80 units on a scale
STANDARD_DEVIATION 4.53
Baseline Homework Motivation Index19.83 units on a scale
STANDARD_DEVIATION 3.95
19.55 units on a scale
STANDARD_DEVIATION 4.24
20.17 units on a scale
STANDARD_DEVIATION 4.49
19.85 units on a scale
STANDARD_DEVIATION 3.22
Columbia Suicide Severity Rating Scale (C-SSRS)3.36 units on a scale
STANDARD_DEVIATION 1.45
3.14 units on a scale
STANDARD_DEVIATION 1.77
3.25 units on a scale
STANDARD_DEVIATION 1.26
4.0 units on a scale
STANDARD_DEVIATION 1
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants2 Participants2 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
50 Participants20 Participants16 Participants14 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
General Anxiety Disorder-7 (GAD-7)11.38 units on a scale
STANDARD_DEVIATION 4.64
12.55 units on a scale
STANDARD_DEVIATION 3.31
10.11 units on a scale
STANDARD_DEVIATION 5.57
11.25 units on a scale
STANDARD_DEVIATION 4.89
Patient Health Questionnaire-9 (PHQ-9)10.63 units on a scale
STANDARD_DEVIATION 6.32
12.00 units on a scale
STANDARD_DEVIATION 6.9
9.83 units on a scale
STANDARD_DEVIATION 6.86
9.85 units on a scale
STANDARD_DEVIATION 5.08
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
9 Participants4 Participants3 Participants2 Participants
Race (NIH/OMB)
Black or African American
13 Participants3 Participants4 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
38 Participants15 Participants11 Participants12 Participants
Region of Enrollment
United States
60 Participants22 Participants18 Participants20 Participants
Sex: Female, Male
Female
40 Participants15 Participants14 Participants11 Participants
Sex: Female, Male
Male
20 Participants7 Participants4 Participants9 Participants
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Current Hyperactive Symptom Count (C)
5.25 units on a scale
STANDARD_DEVIATION 2.1
5.05 units on a scale
STANDARD_DEVIATION 1.96
4.94 units on a scale
STANDARD_DEVIATION 2.73
5.75 units on a scale
STANDARD_DEVIATION 1.55
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Current Hyperactive Total Rating Score (D)
16.02 units on a scale
STANDARD_DEVIATION 4.63
15.36 units on a scale
STANDARD_DEVIATION 4.28
15.89 units on a scale
STANDARD_DEVIATION 6.06
16.85 units on a scale
STANDARD_DEVIATION 3.51
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Current Inattention Symptom Count (A)
7.30 units on a scale
STANDARD_DEVIATION 1.36
7.27 units on a scale
STANDARD_DEVIATION 1.12
7.50 units on a scale
STANDARD_DEVIATION 1.58
7.15 units on a scale
STANDARD_DEVIATION 1.42
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Current Inattention Total Rating Score (B)
19.91 units on a scale
STANDARD_DEVIATION 3.69
19.59 units on a scale
STANDARD_DEVIATION 3.72
20.44 units on a scale
STANDARD_DEVIATION 3.67
19.80 units on a scale
STANDARD_DEVIATION 3.81
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Current Total ADHD Rating Score (F)
52.75 units on a scale
STANDARD_DEVIATION 9.39
52.09 units on a scale
STANDARD_DEVIATION 7.98
53.72 units on a scale
STANDARD_DEVIATION 11.9
52.60 units on a scale
STANDARD_DEVIATION 8.67
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Current Total ADHD Symptom Count (E)
18.37 units on a scale
STANDARD_DEVIATION 3.78
18.32 units on a scale
STANDARD_DEVIATION 2.77
18.44 units on a scale
STANDARD_DEVIATION 5.14
18.35 units on a scale
STANDARD_DEVIATION 3.5
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Past hyperactive/impulsive Symptom Count (I)
5.98 units on a scale
STANDARD_DEVIATION 2.42
6.14 units on a scale
STANDARD_DEVIATION 2.29
5.17 units on a scale
STANDARD_DEVIATION 3
6.55 units on a scale
STANDARD_DEVIATION 1.82
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Past Hyper/Impulsive Total Rating Score (J)
17.58 units on a scale
STANDARD_DEVIATION 5.86
17.50 units on a scale
STANDARD_DEVIATION 5.69
15.78 units on a scale
STANDARD_DEVIATION 7.11
19.30 units on a scale
STANDARD_DEVIATION 4.4
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Past Inattention Symptom Count (G)
7.23 units on a scale
STANDARD_DEVIATION 1.92
7.32 units on a scale
STANDARD_DEVIATION 2.19
7.33 units on a scale
STANDARD_DEVIATION 1.94
7.05 units on a scale
STANDARD_DEVIATION 1.64
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Past inattention Total Rating Score (H)
20.03 units on a scale
STANDARD_DEVIATION 4.97
19.91 units on a scale
STANDARD_DEVIATION 5.77
20.28 units on a scale
STANDARD_DEVIATION 4.55
19.95 units on a scale
STANDARD_DEVIATION 4.62
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Past Total ADHD Rating Score (L)
37.62 units on a scale
STANDARD_DEVIATION 9.5
37.41 units on a scale
STANDARD_DEVIATION 10
36.06 units on a scale
STANDARD_DEVIATION 10.71
39.25 units on a scale
STANDARD_DEVIATION 7.89
The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report
Past Total Adhd Symptom Count (K)
13.22 units on a scale
STANDARD_DEVIATION 3.66
13.45 units on a scale
STANDARD_DEVIATION 3.49
12.50 units on a scale
STANDARD_DEVIATION 4.44
13.60 units on a scale
STANDARD_DEVIATION 3.14

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 180 / 20
other
Total, other adverse events
0 / 220 / 180 / 20
serious
Total, serious adverse events
0 / 220 / 180 / 20

Outcome results

Primary

Homework Concentration Index

This measure looks at how concentrated participants were while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True. There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = worse concentration. The total score is summed. Numbers below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below were averaged for T1 (Sessions 1+2) and T2 (Sessions 3-12).

Time frame: Participants had 2 weeks to complete sessions 1-7, a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks.The 1-7 and 8-12 time points were only for compensation purposes and were not outcome measure points.

Population: Number of participants analyzed differs between timepoints as some participants did not complete enough sessions or the sessions were faulty, and they were excluded from T2. Some participants also dropped out after 2 sessions.

ArmMeasureGroupValue (MEAN)Dispersion
VR PassthroughHomework Concentration IndexSessions 1+2 (T1)(Baseline)15.93 units on a scaleStandard Deviation 4.69
VR PassthroughHomework Concentration IndexSessions 3-12 (T2)11.82 units on a scaleStandard Deviation 5.19
Virtual RealityHomework Concentration IndexSessions 1+2 (T1)(Baseline)16.17 units on a scaleStandard Deviation 6.03
Virtual RealityHomework Concentration IndexSessions 3-12 (T2)12.75 units on a scaleStandard Deviation 3.88
Virtual Reality + FeedbackHomework Concentration IndexSessions 1+2 (T1)(Baseline)17.93 units on a scaleStandard Deviation 5.57
Virtual Reality + FeedbackHomework Concentration IndexSessions 3-12 (T2)12.96 units on a scaleStandard Deviation 4.37
Primary

Objective On-Task Assessment Algorithm

Percentage of time on-task during each study session utilizing the Objective On-Task Assessment algorithmic mouse and keyboard click data. There are no subscales in this measure. Percentages below are for sessions 1-2 (T1) and 3-12 (T2). Participants had 2 weeks to complete sessions 1-7 and a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation/motivational purposes (payment after sessions 1-7 and after 8-12) and were not outcome measurement time points. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions, which we considered 'baseline,' giving us a base focus score before participants put on a headset. Participants wore the headsets for sessions 3-12. Percentages below were averaged for each time point. T1 is an average of session 1+2's percentages. T2 is an average of sessions 3-12's percentages.

Time frame: Participants had 2 weeks to complete sessions 1-7 and a 3rd week to complete the last 5 sessions, equaling 12 sessions within 3 weeks.

Population: Number of participants analyzed differs between the overall number analyzed as some participants did not complete enough sessions or the sessions were faulty, and they were excluded from this measure. The number analyzed here is even less than the other outcome measures as it is easier to get measure information through surveys if a session is faulty, over the whole focus algorithm, which doesn't capture information if there are glitches in the virtual reality system.

ArmMeasureGroupValue (MEAN)Dispersion
VR PassthroughObjective On-Task Assessment AlgorithmSessions 1+2 (T1)(Baseline).86 percentage of time focusedStandard Deviation 0.21
VR PassthroughObjective On-Task Assessment AlgorithmSessions 3-12 (T2).83 percentage of time focusedStandard Deviation 0.04
Virtual RealityObjective On-Task Assessment AlgorithmSessions 1+2 (T1)(Baseline).62 percentage of time focusedStandard Deviation 0.35
Virtual RealityObjective On-Task Assessment AlgorithmSessions 3-12 (T2).85 percentage of time focusedStandard Deviation 0.06
Virtual Reality + FeedbackObjective On-Task Assessment AlgorithmSessions 1+2 (T1)(Baseline).83 percentage of time focusedStandard Deviation 0.27
Virtual Reality + FeedbackObjective On-Task Assessment AlgorithmSessions 3-12 (T2).95 percentage of time focusedStandard Deviation 0.01
Secondary

Homework Effort Index

The Homework Effort Index looks at how much effort participants were able to put in while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True. There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = greater levels of effort. The total score is summed. Scores below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below are averaged for T1 and T2.

Time frame: Participants had 2 weeks to complete sessions 1-7, a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation purposes and were not outcome measure points.

Population: Number of participants analyzed differs between timepoints as some participants did not complete enough sessions or the sessions were faulty, and they were excluded from T2. Some participants also dropped out after 2 sessions.

ArmMeasureGroupValue (MEAN)Dispersion
VR PassthroughHomework Effort IndexSessions 3-12 (T2)19.95 units on a scaleStandard Deviation 5.31
VR PassthroughHomework Effort IndexSessions 1+2 (T1)(Baseline)19.34 units on a scaleStandard Deviation 3.93
Virtual RealityHomework Effort IndexSessions 3-12 (T2)19.63 units on a scaleStandard Deviation 4.42
Virtual RealityHomework Effort IndexSessions 1+2 (T1)(Baseline)17.69 units on a scaleStandard Deviation 3.06
Virtual Reality + FeedbackHomework Effort IndexSessions 1+2 (T1)(Baseline)17.43 units on a scaleStandard Deviation 3.05
Virtual Reality + FeedbackHomework Effort IndexSessions 3-12 (T2)19.92 units on a scaleStandard Deviation 5.08
Secondary

Homework Motivation Index

The Homework Motivation Index measures how motivated participants were while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True.There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = greater levels of motivation. The total score is summed. Scores below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below were averaged for T1 and T2.

Time frame: Participants had 2 weeks to complete sessions 1-7, a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation purposes and were not outcome measure points.

Population: Number of participants analyzed differs between timepoints as some participants did not complete enough sessions or the sessions were faulty, and they were excluded from T2. Some participants also dropped out after 2 sessions.

ArmMeasureGroupValue (MEAN)Dispersion
VR PassthroughHomework Motivation IndexSessions 1+2 (T1)(Baseline)20.73 units on a scaleStandard Deviation 4.2
VR PassthroughHomework Motivation IndexSessions 3-12 (T2)21.08 units on a scaleStandard Deviation 6.89
Virtual RealityHomework Motivation IndexSessions 1+2 (T1)(Baseline)19.94 units on a scaleStandard Deviation 3.4
Virtual RealityHomework Motivation IndexSessions 3-12 (T2)20.53 units on a scaleStandard Deviation 5.3
Virtual Reality + FeedbackHomework Motivation IndexSessions 1+2 (T1)(Baseline)19.35 units on a scaleStandard Deviation 3.21
Virtual Reality + FeedbackHomework Motivation IndexSessions 3-12 (T2)20.89 units on a scaleStandard Deviation 5.07

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026