Trial Outcomes & Findings for VR Intervention to Improve Police Safety (NCT NCT03605368)

Last Updated: 2024-03-27

Results Overview

The primary efficacy endpoint is the change in live in-person (Phase IIA) or virtual (Phase IIB) Police Interaction Assessment Scores between the Floreo PSM Virtual Reality Intervention and BE SAFE Video-Based intervention (Phase IIA) or treatment-as-usual (Phase IIB) from pre-treatment to post-treatment. Greater pre-treatment to post-treatment scores indicate better 3rd party ratings of social skills in that domain. The range of possible scores for the Police Interaction Assessment is -3 (performance got significantly worse from pre-treatment to post-treatment) to 3 (performance improved significantly from pre-treatment to post-treatment) on each variable (overall behavior, appropriate response, orienting, and fidgeting).

Recruitment status

COMPLETED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

The Police Interaction Assessment was administered pre- and post-intervention (~2 weeks apart). Outcome measure data represent the difference in Police Interaction Assessment scores (post-intervention minus pre-intervention.)

Results posted on

2024-03-27

Participant Flow

Of 158 individuals enrolled, 28 did not meet inclusion criteria (low IQ scores), and we could not confirm eligibility for 18 individuals due to lost contact.

Participant milestones

Participant milestones
Measure	Phase IIA - In-Person Floreo PSM Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIA - In-Person BeSAFE Video Modeling Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIB - Remote Floreo PSM Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.	Phase IIB - Remote Treatment-As-Usual (TAU) Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.
Overall Study STARTED	25	25	31	31
Overall Study COMPLETED	23	24	24	26
Overall Study NOT COMPLETED	2	1	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase IIA - In-Person Floreo PSM Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIA - In-Person BeSAFE Video Modeling Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIB - Remote Floreo PSM Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.	Phase IIB - Remote Treatment-As-Usual (TAU) Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.
Overall Study Lost to Follow-up	2	1	3	2
Overall Study Withdrawal by Subject	0	0	4	3

Baseline Characteristics

Two participants in Phase IIB have missing age information: 1 Floreo PSM, 1 TAU.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase IIA - In-Person Floreo PSM n=23 Participants Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIA - In-Person BeSAFE Video Modeling n=24 Participants Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIB - Remote Floreo PSM n=24 Participants Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.	Phase IIB - Remote Treatment-As-Usual (TAU) n=26 Participants Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.	Total n=97 Participants Total of all reporting groups
Age, Continuous	21.87 years STANDARD_DEVIATION 10.50 • n=23 Participants • Two participants in Phase IIB have missing age information: 1 Floreo PSM, 1 TAU.	21.50 years STANDARD_DEVIATION 11.44 • n=24 Participants • Two participants in Phase IIB have missing age information: 1 Floreo PSM, 1 TAU.	18.26 years STANDARD_DEVIATION 6.29 • n=23 Participants • Two participants in Phase IIB have missing age information: 1 Floreo PSM, 1 TAU.	19.92 years STANDARD_DEVIATION 8.39 • n=25 Participants • Two participants in Phase IIB have missing age information: 1 Floreo PSM, 1 TAU.	20.39 years STANDARD_DEVIATION 9.16 • n=95 Participants • Two participants in Phase IIB have missing age information: 1 Floreo PSM, 1 TAU.
Sex/Gender, Customized Sex assigned at birth · Female	4 Participants n=23 Participants	4 Participants n=24 Participants	10 Participants n=24 Participants	11 Participants n=26 Participants	29 Participants n=97 Participants
Sex/Gender, Customized Sex assigned at birth · Male	19 Participants n=23 Participants	20 Participants n=24 Participants	14 Participants n=24 Participants	15 Participants n=26 Participants	68 Participants n=97 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=23 Participants	1 Participants n=24 Participants	4 Participants n=24 Participants	2 Participants n=26 Participants	9 Participants n=97 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=23 Participants	23 Participants n=24 Participants	20 Participants n=24 Participants	24 Participants n=26 Participants	88 Participants n=97 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=26 Participants	0 Participants n=97 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=23 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=26 Participants	0 Participants n=97 Participants
Race (NIH/OMB) Asian	1 Participants n=23 Participants	1 Participants n=24 Participants	0 Participants n=24 Participants	1 Participants n=26 Participants	3 Participants n=97 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=26 Participants	0 Participants n=97 Participants
Race (NIH/OMB) Black or African American	6 Participants n=23 Participants	2 Participants n=24 Participants	5 Participants n=24 Participants	1 Participants n=26 Participants	14 Participants n=97 Participants
Race (NIH/OMB) White	14 Participants n=23 Participants	20 Participants n=24 Participants	16 Participants n=24 Participants	22 Participants n=26 Participants	72 Participants n=97 Participants
Race (NIH/OMB) More than one race	2 Participants n=23 Participants	1 Participants n=24 Participants	1 Participants n=24 Participants	2 Participants n=26 Participants	6 Participants n=97 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=24 Participants	2 Participants n=24 Participants	0 Participants n=26 Participants	2 Participants n=97 Participants
Region of Enrollment United States	23 participants n=23 Participants	24 participants n=24 Participants	24 participants n=24 Participants	26 participants n=26 Participants	97 participants n=97 Participants
Wechsler Abbreviated Scale of Intelligence - 2nd Edition	100.70 units on a scale STANDARD_DEVIATION 15.52 • n=23 Participants • In Phase IIB, two participants had missing IQ information (1 Floreo PSM, 1 TAU).	102.92 units on a scale STANDARD_DEVIATION 14.36 • n=24 Participants • In Phase IIB, two participants had missing IQ information (1 Floreo PSM, 1 TAU).	102.26 units on a scale STANDARD_DEVIATION 14.60 • n=23 Participants • In Phase IIB, two participants had missing IQ information (1 Floreo PSM, 1 TAU).	104.00 units on a scale STANDARD_DEVIATION 13.15 • n=25 Participants • In Phase IIB, two participants had missing IQ information (1 Floreo PSM, 1 TAU).	102.47 units on a scale STANDARD_DEVIATION 14.41 • n=95 Participants • In Phase IIB, two participants had missing IQ information (1 Floreo PSM, 1 TAU).
Autism Diagnosis	23 Participants n=23 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	26 Participants n=26 Participants	97 Participants n=97 Participants

PRIMARY outcome

Timeframe: The Police Interaction Assessment was administered pre- and post-intervention (~2 weeks apart). Outcome measure data represent the difference in Police Interaction Assessment scores (post-intervention minus pre-intervention.)

Population: The analysis population is described in Baseline Characteristics.

Outcome measures

Outcome measures
Measure	Phase IIA - In-Person Floreo PSM n=23 Participants Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIA - In-Person BeSAFE Video Modeling n=24 Participants Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIB - Remote Floreo PSM n=24 Participants Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.	Phase IIB - Remote Treatment-As-Usual (TAU) n=26 Participants Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.
Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment Orienting	.18 Change from baseline - units on a scale Standard Deviation .49	.18 Change from baseline - units on a scale Standard Deviation .66	-.14 Change from baseline - units on a scale Standard Deviation .46	.20 Change from baseline - units on a scale Standard Deviation .73
Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment Fidgeting	-.03 Change from baseline - units on a scale Standard Deviation .56	.44 Change from baseline - units on a scale Standard Deviation .52	-.31 Change from baseline - units on a scale Standard Deviation .53	-.07 Change from baseline - units on a scale Standard Deviation .45
Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment Overall Behavior	.13 Change from baseline - units on a scale Standard Deviation .42	.29 Change from baseline - units on a scale Standard Deviation .50	-.28 Change from baseline - units on a scale Standard Deviation .39	.02 Change from baseline - units on a scale Standard Deviation .41
Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment Appropriate Response	.04 Change from baseline - units on a scale Standard Deviation .29	.21 Change from baseline - units on a scale Standard Deviation .35	-.13 Change from baseline - units on a scale Standard Deviation .34	.06 Change from baseline - units on a scale Standard Deviation .29

SECONDARY outcome

Timeframe: Baseline and immediately post-intervention (~2 weeks apart)

Population: The analysis population is described in Baseline Characteristics. Missing data: In Phase IIA, no data are missing. In Phase IIB, 6 participants in the Floreo condition and 3 in the TAU condition are missing Police Interaction Knowledge questionnaire data.

The secondary endpoint includes changes in Police Interaction Knowledge Questionnaire Scores from Pre-Treatment to Post-Treatment or Pre-TAU to Post-TAU. Before and after the in-person Floreo VR intervention, participants completed a 10-question survey that asked about their feelings of comfort and safety when interacting with police officers. The scale for each question ranged from 1-7, with 7 indicating greater feelings of safety, comfort, and knowledge and 1 indicating fewer feelings of safety, comfort, and knowledge. Scores were summed to create a total score, which ranged from 10 to 70, and then subtracted to calculate a change score (post-intervention minus pre-intervention). Change scores, which had a possible range of -60 to +60, were compared between groups. Greater change scores after intervention or TAU indicate greater feelings of safety, comfort, and knowledge when interacting with police.

Outcome measures

Outcome measures
Measure	Phase IIA - In-Person Floreo PSM n=23 Participants Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIA - In-Person BeSAFE Video Modeling n=24 Participants Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.	Phase IIB - Remote Floreo PSM n=18 Participants Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.	Phase IIB - Remote Treatment-As-Usual (TAU) n=23 Participants Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments.
Change in Police Interaction Knowledge	8.09 units on a scale Standard Deviation 9.54	9.71 units on a scale Standard Deviation 8.68	8.11 units on a scale Standard Deviation 9.09	2.70 units on a scale Standard Deviation 8.35

Adverse Events

Phase IIA - In-person

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase IIB - Remote

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

Julia Parish-Morris

Children's Hospital of Philadelphia

Phone: 267-426-7540

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place