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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

220 participants

Primary outcome timeframe

Baseline, 1-month and 3-months post-randomization

Results posted on

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

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.
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

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-randomization

Population: 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

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-randomization

Population: 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

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-randomization

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Experimental Caregiver

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Comparative Control Youth

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Comparative Control Caregiver

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr, Nicholas Thomson

Virginia Commonwealth University

Phone: (804) 828-6386

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place