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| ID | Type | Description | Link |
|---|---|---|---|
| 1R42MH115539-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Floreo, Inc. | INDUSTRY |
| National Institute of Mental Health (NIMH) | NIH |
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The primary objective of this study is to demonstrate the efficacy of Floreo's police safety module (PSM) in adolescents and adults with autism spectrum disorder (ASD) by assessing improvement in police interaction skills as compared to a video modeling intervention.
Advances in virtual reality (VR) technology offer new opportunities to design interventions targeting the core deficits associated with autism spectrum disorder (ASD) and promote acquisition of skills necessary for effective navigation of challenging social situations, such as engagement with law enforcement. Researchers have explored the potential of virtual reality technology in targeting autism-related deficits, but at this time there are no evidence-based VR interventions for ASD. While most research labelled VR for the purposes of therapy has not been immersive, in recent years, the commercial introduction of head-mounted displays (HMD) and lower cost of virtual reality technology have led to greater interest in therapeutic applications of VR. As part of a mission to develop VR products for individuals with ASD, investigators will collaborate with a commercial tech start-up company, Floreo Technology, to study a mobile VR module for police safety skills. Investigators seek to evaluate the safety and feasibility of the mobile VR police safety module (PSM) and the effectiveness of the module in improving police interaction skills in adolescents and adults with ASD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase IIA - in-person | Active Comparator | Participants will be assigned to either a) a virtual reality-based intervention or b) an video modeling intervention both aimed at improving police interaction skills. Assessments of police skills will occur before intervention and after intervention (three sessions of each). |
|
| Phase IIB - remote | Active Comparator | Participants will be assigned to either a) three sessions of virtual reality-based intervention aimed at improving police interaction skills or b) no intervention. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Intervention | Behavioral | Floreo's Police Safety Module (PSM) offers a supervised VR experience for people with ASD. The software is an application that provides a 3D immersive scene for headset-compatible smartphones. The person with ASD will use a smartphone capable of running the application with a dedicated headset providing the virtual environment. The PSM provides an immersive story-based intervention that shows a fully realized and intricately detailed urban environment designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person with ASD as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | 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). | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Police Interaction Knowledge | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Parish-Morris, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Vijay Ravindran | Floreo, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline participants is taken to mean participants that completed the study and included in the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Two participants in Phase IIB have missing age information: 1 Floreo PSM, 1 TAU. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | 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). | The analysis population is described in Baseline Characteristics. | Posted | Mean | Standard Deviation | Change from baseline - units on a scale | 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.) |
Adverse events were monitored by study staff at baseline, during intervention or TAU, at the post-intervention assessment, and at follow-up. Monitoring continued through study completion, which was an average of 2 weeks for Phase IIA and 6 weeks for Phase IIB.
No series adverse events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase IIA - In-person | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Parish-Morris | Children's Hospital of Philadelphia | 267-426-7540 | parishmorrisj@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2020 | Jan 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2020 | Jan 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| Video Modeling Intervention | Behavioral | 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. |
|
| No intervention | Behavioral | Participants will follow all study procedures with the exception of the VR-based intervention including assessments. |
|
| Baseline and immediately post-intervention (~2 weeks apart) |
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Wechsler Abbreviated Scale of Intelligence - 2nd Edition | The Wechsler Abbreviated Scale of Intelligence - Second Edition is a measure designed to estimate full-scale intelligence quotient (FSIQ). The FSIQ provides an overall estimate of an individual's general intellectual ability, with a mean of 100 and a standard deviation of 15 (range: 40-160). Higher scores indicate greater estimated intellectual ability. | In Phase IIB, two participants had missing IQ information (1 Floreo PSM, 1 TAU). | Mean | Standard Deviation | units on a scale |
|
| Autism Diagnosis | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| Secondary | Change in Police Interaction Knowledge | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and immediately post-intervention (~2 weeks apart) |
|
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Phase IIB - Remote | 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. | 0 | 50 | 0 | 50 | 0 | 50 |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Regression, Linear |
| .05 |
| Mean Difference (Final Values) |
| 5.42 |
| Standard Error of the Mean |
| 2.73 |
| 2-Sided |
| Equivalence |
A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p<.05. |