Trial Outcomes & Findings for Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD (NCT NCT06301516)
NCT ID: NCT06301516
Last Updated: 2026-06-17
Results Overview
Participants enrolled in Impact VR will complete the first of four sessions. The Inventory of Callous-Unemotional Traits (ICU) is a 24-item questionnaire used to assess traits like lack of empathy, uncaring behavior, and restricted emotions in youth. Rated on a 4-point Likert scale (0=not at all true to 3=definitely true), it is scored by summing all items, with higher scores indicating greater CU traits. Sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school, or a mutual private meeting place. A reduction in the score indicates improvement. Both youth and caregiver subjects were assessed.
COMPLETED
PHASE1
220 participants
Baseline, 1-month and 3-months post-randomization
2026-06-17
Participant Flow
Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each arm enrolled 55 caregivers. Overall, 110 youth and 110 caregivers, evenly divided by arm.
Participant milestones
| Measure |
Experimental Youth
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. Only the minor participant demographic data was collected and will be reported. For the outcome sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Experimental Caregiver
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. Only the minor participant demographic data was collected and will be reported. For the outcome sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Comparative Control Youth
Participants enrolled into the comparative control group will complete a one-time PowerPoint presentation that provides an overview of emotion expressions and instructions on how to recognize emotions in others. Only the minor participant demographic data was collected and will be reported. For the outcome sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Comparative Caregiver
Participants enrolled into the comparative control group will complete a one-time PowerPoint presentation that provides an overview of emotion expressions and instructions on how to recognize emotions in others. Only the minor participant demographic data was collected and will be reported. For the outcome sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
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|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
55
|
55
|
|
Overall Study
COMPLETED
|
55
|
55
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Overall 110 youth: 55 experimental youth, and 55 comparative control youth
Baseline characteristics by cohort
| Measure |
Experimental Youth
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. Only the minor participant demographic data was collected and will be reported. For the outcome sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Comparative Control Youth
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. Only the minor participant demographic data was collected and will be reported. For the outcome sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Caregivers Aggregate Demographic (Experimental and Control Caregivers)
Caregiver baseline data was not collected. The focus was on the youth arms.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age, Continous
|
13.91 years
STANDARD_DEVIATION 2.27 • n=9 Participants • Overall 110 youth: 55 experimental youth, and 55 comparative control youth
|
13.69 years
STANDARD_DEVIATION 2.43 • n=27 Participants • Overall 110 youth: 55 experimental youth, and 55 comparative control youth
|
—
|
13.8 years
STANDARD_DEVIATION 2.35 • n=265 Participants • Overall 110 youth: 55 experimental youth, and 55 comparative control youth
|
|
Sex: Female, Male
Sex: Female, Male · Female
|
22 Participants
n=9 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
24 Participants
n=27 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
—
|
46 Participants
n=265 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
|
Sex: Female, Male
Sex: Female, Male · Male
|
33 Participants
n=9 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
31 Participants
n=27 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
—
|
64 Participants
n=265 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=9 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
0 Participants
n=27 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
—
|
0 Participants
n=265 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
|
Race (NIH/OMB)
Race · Asian
|
0 Participants
n=9 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
0 Participants
n=27 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
—
|
0 Participants
n=265 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
0 Participants
n=27 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
—
|
0 Participants
n=265 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
|
Race (NIH/OMB)
Race · Black or African American
|
33 Participants
n=9 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
31 Participants
n=27 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
—
|
64 Participants
n=265 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
|
Race (NIH/OMB)
Race · White
|
18 Participants
n=9 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
19 Participants
n=27 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
—
|
37 Participants
n=265 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=9 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
0 Participants
n=27 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
—
|
0 Participants
n=265 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
4 Participants
n=9 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
5 Participants
n=27 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
—
|
9 Participants
n=265 Participants • Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
|
PRIMARY outcome
Timeframe: Baseline, 1-month and 3-months post-randomizationPopulation: For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver.
Participants enrolled in Impact VR will complete the first of four sessions. The Inventory of Callous-Unemotional Traits (ICU) is a 24-item questionnaire used to assess traits like lack of empathy, uncaring behavior, and restricted emotions in youth. Rated on a 4-point Likert scale (0=not at all true to 3=definitely true), it is scored by summing all items, with higher scores indicating greater CU traits. Sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school, or a mutual private meeting place. A reduction in the score indicates improvement. Both youth and caregiver subjects were assessed.
Outcome measures
| Measure |
Experimental Youth
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Experimental Caregiver
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Comparative Control Youth
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Comparative Control Caregiver
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
|---|---|---|---|---|
|
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Callous-Unemotional Traits in Both Subjects and Caregivers (Callous-Unemotional Traits)
Baseline
|
25.96 score on a scale (ICU questionnaire)
Standard Deviation 9.28
|
28.06 score on a scale (ICU questionnaire)
Standard Deviation 11.73
|
25.01 score on a scale (ICU questionnaire)
Standard Deviation 9.36
|
27.22 score on a scale (ICU questionnaire)
Standard Deviation 12.62
|
|
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Callous-Unemotional Traits in Both Subjects and Caregivers (Callous-Unemotional Traits)
1 Month post-randomization
|
24.23 score on a scale (ICU questionnaire)
Standard Deviation 8.62
|
20.30 score on a scale (ICU questionnaire)
Standard Deviation 9.72
|
24.85 score on a scale (ICU questionnaire)
Standard Deviation 9.59
|
26.90 score on a scale (ICU questionnaire)
Standard Deviation 12.22
|
|
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Callous-Unemotional Traits in Both Subjects and Caregivers (Callous-Unemotional Traits)
3 month post-randomization
|
18.52 score on a scale (ICU questionnaire)
Standard Deviation 8.52
|
20.98 score on a scale (ICU questionnaire)
Standard Deviation 11.11
|
25.07 score on a scale (ICU questionnaire)
Standard Deviation 10.33
|
28.28 score on a scale (ICU questionnaire)
Standard Deviation 12.87
|
PRIMARY outcome
Timeframe: Baseline, 1-month and 3-months post-randomizationPopulation: Each of the two caregiver arms enrolled 55 caregivers. Overall 110 caregivers: 55 experimental caregivers, and 55 comparative control caregiver.
The Conduct Problems subscale from the BASC-3 Caregiver Rating Scales was used to assess caregiver-reported externalizing behavior. This includes items rated on a 4-point Likert scale from 0 (Never) to 3 (Almost Always). The scale measures disruptive behaviors commonly associated with conduct problems, including defiance, rule-breaking, and aggression (e.g., "Breaks the rules," "Lies or cheats"). Improvement is indicated in a reduction in the overall score. A "good" or healthy score generally falls in the average range, indicating that behavioral, emotional, and adaptive functioning are within normal limits. Only caregiver subjects were assessed. T-scores (Mean = 50 , SD = 10) are generated, usually via Q-global® Web-based Administration.
Outcome measures
| Measure |
Experimental Youth
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Experimental Caregiver
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Comparative Control Youth
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Comparative Control Caregiver
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
|---|---|---|---|---|
|
Assess Conduct Problems Subscale From the BASC-3 Caregiver Rating Scales for Caregiver Only
Baseline
|
58.89 score on a questionnaire (BASC-3)
Standard Deviation 15.71
|
54.85 score on a questionnaire (BASC-3)
Standard Deviation 14.52
|
—
|
—
|
|
Assess Conduct Problems Subscale From the BASC-3 Caregiver Rating Scales for Caregiver Only
1 month post-randomization
|
58.93 score on a questionnaire (BASC-3)
Standard Deviation 8.00
|
55.67 score on a questionnaire (BASC-3)
Standard Deviation 13.67
|
—
|
—
|
|
Assess Conduct Problems Subscale From the BASC-3 Caregiver Rating Scales for Caregiver Only
3 month post-randomization
|
47.93 score on a questionnaire (BASC-3)
Standard Deviation 7.25
|
55.66 score on a questionnaire (BASC-3)
Standard Deviation 13.06
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 1-month and 3-months post-randomizationPopulation: For the outcome sessions, each youth arm enrolled 55 subjects. Overall 110 youth: 55 experimental youth, 55 comparative control youth.
Emotion recognition will be measured using the Penn Emotion Recognition Test, which is a computer-based task completed by the youth only. The Penn Emotion Recognition Test (specifically the ER-40) is a computerized neuropsychological tool used to measure an individual's ability to identify and differentiate facial expressions. Participants are shown 40 color photographs of actors (balanced for gender, age, and ethnicity) portraying various emotions. Scoring for the Penn Emotion Recognition Test (ER-40) focuses on two primary metrics: Accuracy and Speed. Results are often further broken down by emotion type and intensity to pinpoint specific social-cognitive deficits. A higher score would indicate improvement. Only youth subjects were assessed.
Outcome measures
| Measure |
Experimental Youth
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Experimental Caregiver
n=55 Participants
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Comparative Control Youth
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
Comparative Control Caregiver
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm.
|
|---|---|---|---|---|
|
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Emotion Recognition/ Youth Arm Only
Baseline
|
29.74 percentage of correct responses (ER-40)
Standard Deviation 7.52
|
29.75 percentage of correct responses (ER-40)
Standard Deviation 6.66
|
—
|
—
|
|
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Emotion Recognition/ Youth Arm Only
1 month post-randomization
|
34.06 percentage of correct responses (ER-40)
Standard Deviation 5.46
|
29.41 percentage of correct responses (ER-40)
Standard Deviation 10.48
|
—
|
—
|
|
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Emotion Recognition/ Youth Arm Only
3 months post-randomization
|
34.81 percentage of correct responses (ER-40)
Standard Deviation 4.66
|
28.57 percentage of correct responses (ER-40)
Standard Deviation 9.87
|
—
|
—
|
Adverse Events
Experimental Youth
Experimental Caregiver
Comparative Control Youth
Comparative Control Caregiver
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr, Nicholas Thomson
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place