Autism Spectrum Disorder, Autism
Conditions
Keywords
Intervention, Technology
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVirtual Reality Intervention
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.
BEHAVIORALVideo 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.
BEHAVIORALNo intervention
Participants will follow all study procedures with the exception of the VR-based intervention including assessments.
Sponsors
Floreo, Inc.
National Institute of Mental Health (NIMH)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Males or females age 12 to 60 years. * Documented autism spectrum disorder (ASD) diagnosis * Verbal Intelligence Quotient (IQ) \>/= 75 (verbal and non-verbal) * Informed consent (if adult) or parental/guardian permission (if child or adult with diminished capacity) and, if applicable, assent
Exclusion criteria
* Participation in pilot virtual reality (VR) study at the Children's Hospital of Philadelphia (CHOP) * Personal or family history of seizures or a seizure disorder * Primary sensory impairment (e.g., blindness, deafness) * Personal or family history of migraines * History of vertigo * History of strabismus, other eye muscle problems, or eye surgery * History of concussion with hospitalization * Diagnosis of a known genetic syndrome (e.g., Down syndrome, Fragile X syndrome) * History of a medical condition which has affected/affects cognitive, sensory, or motor functioning (e.g., Fetal Alcohol Syndrome, brain injury, stroke, brain tumor) * Non-English speaking * Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | 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.) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Police Interaction Knowledge | Baseline and immediately post-intervention (~2 weeks apart) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 24 |
| 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. | 24 |
| 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. | 26 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 4 | 3 |
Baseline characteristics
| Characteristic | Phase IIA - In-Person Floreo PSM | Phase IIA - In-Person BeSAFE Video Modeling | Phase IIB - Remote Floreo PSM | Phase IIB - Remote Treatment-As-Usual (TAU) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 21.87 years STANDARD_DEVIATION 10.5 | 21.50 years STANDARD_DEVIATION 11.44 | 18.26 years STANDARD_DEVIATION 6.29 | 19.92 years STANDARD_DEVIATION 8.39 | 20.39 years STANDARD_DEVIATION 9.16 |
| Autism Diagnosis | 23 Participants | 24 Participants | 24 Participants | 26 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 4 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 23 Participants | 20 Participants | 24 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 5 Participants | 1 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 20 Participants | 16 Participants | 22 Participants | 72 Participants |
| Region of Enrollment United States | 23 participants | 24 participants | 24 participants | 26 participants | 97 participants |
| Sex/Gender, Customized Sex assigned at birth Female | 4 Participants | 4 Participants | 10 Participants | 11 Participants | 29 Participants |
| Sex/Gender, Customized Sex assigned at birth Male | 19 Participants | 20 Participants | 14 Participants | 15 Participants | 68 Participants |
| Wechsler Abbreviated Scale of Intelligence - 2nd Edition | 100.70 units on a scale STANDARD_DEVIATION 15.52 | 102.92 units on a scale STANDARD_DEVIATION 14.36 | 102.26 units on a scale STANDARD_DEVIATION 14.6 | 104.00 units on a scale STANDARD_DEVIATION 13.15 | 102.47 units on a scale STANDARD_DEVIATION 14.41 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 50 |
| other Total, other adverse events | 0 / 47 | 0 / 50 |
| serious Total, serious adverse events | 0 / 47 | 0 / 50 |
Outcome results
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase IIA - In-Person Floreo PSM | 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 0.56 |
| Phase IIA - In-Person Floreo PSM | 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 0.42 |
| Phase IIA - In-Person Floreo PSM | 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 0.29 |
| Phase IIA - In-Person Floreo PSM | 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 0.49 |
| Phase IIA - In-Person BeSAFE Video Modeling | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Overall Behavior | .29 Change from baseline - units on a scale | Standard Deviation 0.5 |
| Phase IIA - In-Person BeSAFE Video Modeling | 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 0.66 |
| Phase IIA - In-Person BeSAFE Video Modeling | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Fidgeting | .44 Change from baseline - units on a scale | Standard Deviation 0.52 |
| Phase IIA - In-Person BeSAFE Video Modeling | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Appropriate Response | .21 Change from baseline - units on a scale | Standard Deviation 0.35 |
| Phase IIB - Remote Floreo PSM | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Appropriate Response | -.13 Change from baseline - units on a scale | Standard Deviation 0.34 |
| Phase IIB - Remote Floreo PSM | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Orienting | -.14 Change from baseline - units on a scale | Standard Deviation 0.46 |
| Phase IIB - Remote Floreo PSM | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Fidgeting | -.31 Change from baseline - units on a scale | Standard Deviation 0.53 |
| Phase IIB - Remote Floreo PSM | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Overall Behavior | -.28 Change from baseline - units on a scale | Standard Deviation 0.39 |
| Phase IIB - Remote Treatment-As-Usual (TAU) | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Appropriate Response | .06 Change from baseline - units on a scale | Standard Deviation 0.29 |
| Phase IIB - Remote Treatment-As-Usual (TAU) | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Fidgeting | -.07 Change from baseline - units on a scale | Standard Deviation 0.45 |
| Phase IIB - Remote Treatment-As-Usual (TAU) | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Overall Behavior | .02 Change from baseline - units on a scale | Standard Deviation 0.41 |
| Phase IIB - Remote Treatment-As-Usual (TAU) | Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment | Orienting | .20 Change from baseline - units on a scale | Standard Deviation 0.73 |
Comparison: Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).p-value: 0.23Regression, Linear
Comparison: Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).p-value: 0.07Regression, Linear
Comparison: Orienting. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).p-value: 0.99Regression, Linear
Comparison: Fidget. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).p-value: 0.005Regression, Linear
Comparison: Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).p-value: 0.01Regression, Linear
Comparison: Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).p-value: 0.04Regression, Linear
Comparison: Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).p-value: 0.06Regression, Linear
p-value: 0.09Regression, Linear
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase IIA - In-Person Floreo PSM | Change in Police Interaction Knowledge | 8.09 units on a scale | Standard Deviation 9.54 |
| Phase IIA - In-Person BeSAFE Video Modeling | Change in Police Interaction Knowledge | 9.71 units on a scale | Standard Deviation 8.68 |
| Phase IIB - Remote Floreo PSM | Change in Police Interaction Knowledge | 8.11 units on a scale | Standard Deviation 9.09 |
| Phase IIB - Remote Treatment-As-Usual (TAU) | Change in Police Interaction Knowledge | 2.70 units on a scale | Standard Deviation 8.35 |
p-value: 0.55Regression, Linear
p-value: 0.05Regression, Linear