Autism Spectrum DisorderNCT03605368

VR Intervention to Improve Police Safety

A study testing Virtual Reality Intervention and Video Modeling Intervention in people with Autism Spectrum Disorder and Autism, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 60 years
Conditions the study is for: Autism Spectrum Disorder, Autism
What is being tested?: Virtual Reality Intervention and Video Modeling Intervention
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteUnited States
Study dates: 17 Nov 2017to 12 Oct 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Immersive Virtual Reality as a Tool to Improve Police Safety in Adolescents and Adults With ASD

Read the 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.

Conditions: Autism Spectrum Disorder, Autism
Being tested: Virtual Reality Intervention, Video Modeling Intervention, No intervention
Keywords: Intervention, Technology
Medical subject headings: Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Reality InterventionBehavioural
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.
Video Modeling InterventionBehavioural
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 interventionBehavioural
Participants will follow all study procedures with the exception of the VR-based intervention including assessments.

Study groups in NCT03605368
Study group	Role	What they receive
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). Receives: Behavioral: Virtual Reality Intervention; Behavioral: Video Modeling Intervention
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. Receives: Behavioral: Virtual Reality Intervention; Behavioral: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.)

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 201712 Oct 2022

First posted30 Jul 2018
Study start17 Nov 2017
Primary completion12 Oct 2022
Study completion12 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03605368
Sponsor's protocol ID: 17-014387
Other IDs: 1R42MH115539-01
Status last verified: Feb 2024
First submitted: 23 Jul 2018
Last updated: 27 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immersive Virtual Reality as a Tool to Improve Police Safety in Adolescents and Adults With ASD
ClinicalTrials.gov ID: NCT03605368
Acronym / sponsor ID: 17-014387
Conditions: Autism Spectrum Disorder, Autism
Keywords: Intervention, Technology
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: Floreo, Inc., National Institute of Mental Health (NIMH)
Study start: 17 Nov 2017 (actual)
Primary completion: 12 Oct 2022 (actual)
Study completion: 12 Oct 2022 (actual)
First posted: 30 Jul 2018 (actual)
Results: Posted 27 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Phase IIA - in-person	Active comparator	Behavioral: Virtual Reality Intervention, Behavioral: Video Modeling InterventionParticipants 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	Behavioral: Virtual Reality Intervention, Behavioral: No interventionParticipants 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.

Who may qualify

Ages: 12 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Virtual Reality InterventionFloreo'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.	Behavioural	Phase IIA - in-person, Phase IIB - remote
Video Modeling InterventionThe 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.	Behavioural	Phase IIA - in-person
No interventionParticipants will follow all study procedures with the exception of the VR-based intervention including assessments.	Behavioural	Phase IIB - remote

Primary outcome

Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment
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.)
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).

1 secondary outcome

Change in Police Interaction Knowledge
Time frame: Baseline and immediately post-intervention (~2 weeks apart)

Results and safety

Results posted to the registry on 27 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase IIA - In-Person Floreo PSM	25	23
Phase IIA - In-Person BeSAFE Video Modeling	25	24
Phase IIB - Remote Floreo PSM	31	24
Phase IIB - Remote Treatment-As-Usual (TAU)	31	26

Primary outcome: Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment

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.). Mean (Standard Deviation). Unit: Change from baseline - units on a scale

Measure	Phase IIA - In-Person Floreo PSM n = 23	Phase IIA - In-Person BeSAFE Video Modeling n = 24	Phase IIB - Remote Floreo PSM n = 24	Phase IIB - Remote Treatment-As-Usual (TAU) n = 26
Overall Behavior	.13 (.42)	.29 (.50)	-.28 (.39)	.02 (.41)
Appropriate Response	.04 (.29)	.21 (.35)	-.13 (.34)	.06 (.29)
Orienting	.18 (.49)	.18 (.66)	-.14 (.46)	.20 (.73)
Fidgeting	-.03 (.56)	.44 (.52)	-.31 (.53)	-.07 (.45)

Phase IIA - In-Person Floreo PSM vs Phase IIA - In-Person BeSAFE Video Modeling: Mean Difference (Final Values): .16, p = .23, Regression, Linear
Phase IIA - In-Person Floreo PSM vs Phase IIA - In-Person BeSAFE Video Modeling: Mean Difference (Final Values): .17, p = .07, Regression, Linear
Phase IIA - In-Person Floreo PSM vs Phase IIA - In-Person BeSAFE Video Modeling: Mean Difference (Final Values): -.00, p = .99, Regression, Linear

Population analysed: The analysis population is described in Baseline Characteristics.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase IIA - In-person	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Phase IIB - Remote	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julia Parish-Morris, PhD principal investigator

Children's Hospital of Philadelphia

Vijay Ravindran principal investigator

Floreo, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Intervention and Video Modeling Intervention in people with Autism Spectrum Disorder and Autism, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment (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.)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03605368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.