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VR for Joint Attention Support in ASD
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Autism Spectrum Disorder | Device: Floreo Joint Attention Module Behavioral: Regularly Scheduled Therapy | Phase 2 |
The study will be a Phase II randomized controlled trial in which the Floreo VR Joint Attention Module is the intervention being evaluated. Floreo is a mobile application that offers a supervised virtual reality experience for individuals with ASD. The application provides a 3D immersive scene for Google Cardboard-compatible smartphones and a WiFi paired supervisory overview that can run on smartphones or tablets.
The therapeutic content will consist of a Learning Module focused on Joint Attention. This Joint Attention Learning Module will include separate Learning Cards (LCs) that address specific subskills necessary to develop appropriate joint attention. Each Learning Card will consist of a virtual reality environment in a safari-themed setting, complete with animals designed to draw the learner's attention when necessary.
The product will be implemented at The Children's SPOT by a therapist working with a client during the course of a therapy session.
The intervention arm participant would engage in one or two VR episodes during a scheduled session. Each episode would last no more than 5 minutes. If two episodes are done in a day, there is a mandatory break of at least 3 minutes in between them. The sessions would occur two days per week, with at least two days in between sessions to allow the eyes time to rest.
There are 15 total VR sessions in the protocol, and completion of all study sessions would take 8 weeks.
The control condition is treatment as usual, that is, regularly scheduled therapy.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Immersive VR as a Tool to Support Joint Attention Skills in Children With Autism Spectrum Disorder |
| Actual Study Start Date : | July 20, 2018 |
| Actual Primary Completion Date : | July 16, 2019 |
| Actual Study Completion Date : | July 16, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: VR Intervention
Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week
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Device: Floreo Joint Attention Module
Two sessions per week for eight weeks of the Floreo VR Joint Attention Module, delivered via a Google Cardboard compatible VR headset. Each session includes one or two 5-minute VR episodes and an intermission that is at least 3 minutes long
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Active Comparator: Treatment as Usual
Regularly scheduled therapy
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Behavioral: Regularly Scheduled Therapy
therapy as regularly scheduled at therapy center
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- Change from Baseline Joint Attention Protocol score at 12 weeks [ Time Frame: immediately before and 4 weeks after intervention or control period of the study ]A measure developed to rate child behaviors on 16 items involving response to joint attention and initiation of joint attention
- Change from Baseline Joint Attention Assessment score at 12 weeks [ Time Frame: immediately before and 4 weeks after intervention or control period of the study ]an in-person, videotaped, play-based measure to rate frequency of joint attention skills in school-aged children. Instances of each joint attention behavior observed are summed to provide a total Joint Attention Assessment score, with higher numbers reflecting more frequent joint attention behaviors.
- Change from Baseline Vineland Adaptive Behavior Scales, Third Edition total score [ Time Frame: immediately before and 4 weeks after intervention or control period of the study ]a parent-reported measure of adaptive skills, commonly used for assessment of individuals with developmental disabilities. The Vineland provides an Adaptive Behavior Composite (ABC) score, which can be compared to a normative mean score of 100 with a normative standard deviation of 15.
| Ages Eligible for Study: | 7 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented ASD diagnosis, between 7 and 17 years of age
Exclusion Criteria:
- History of seizures, migraines, vertigo, psychosis
| United States, Maryland | |
| Children's SPOT | |
| Columbia, Maryland, United States, 21045 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 8, 2019 | ||||
| First Posted Date ICMJE | July 11, 2019 | ||||
| Last Update Posted Date | July 17, 2019 | ||||
| Actual Study Start Date ICMJE | July 20, 2018 | ||||
| Actual Primary Completion Date | July 16, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline Joint Attention Protocol score at 12 weeks [ Time Frame: immediately before and 4 weeks after intervention or control period of the study ] A measure developed to rate child behaviors on 16 items involving response to joint attention and initiation of joint attention
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | VR for Joint Attention Support in ASD | ||||
| Official Title ICMJE | Immersive VR as a Tool to Support Joint Attention Skills in Children With Autism Spectrum Disorder | ||||
| Brief Summary | The overall objective of this study is to determine the effectiveness of the Floreo VR Joint Attention Module in improving social communication skills in children with ASD. An additional objective is ongoing investigation of the tolerability of the product and the extent of potential adverse effects of Floreo VR, if any. | ||||
| Detailed Description |
The study will be a Phase II randomized controlled trial in which the Floreo VR Joint Attention Module is the intervention being evaluated. Floreo is a mobile application that offers a supervised virtual reality experience for individuals with ASD. The application provides a 3D immersive scene for Google Cardboard-compatible smartphones and a WiFi paired supervisory overview that can run on smartphones or tablets. The therapeutic content will consist of a Learning Module focused on Joint Attention. This Joint Attention Learning Module will include separate Learning Cards (LCs) that address specific subskills necessary to develop appropriate joint attention. Each Learning Card will consist of a virtual reality environment in a safari-themed setting, complete with animals designed to draw the learner's attention when necessary. The product will be implemented at The Children's SPOT by a therapist working with a client during the course of a therapy session. The intervention arm participant would engage in one or two VR episodes during a scheduled session. Each episode would last no more than 5 minutes. If two episodes are done in a day, there is a mandatory break of at least 3 minutes in between them. The sessions would occur two days per week, with at least two days in between sessions to allow the eyes time to rest. There are 15 total VR sessions in the protocol, and completion of all study sessions would take 8 weeks. The control condition is treatment as usual, that is, regularly scheduled therapy. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Autism Spectrum Disorder | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE |
0 | ||||
| Original Estimated Enrollment ICMJE |
20 | ||||
| Actual Study Completion Date ICMJE | July 16, 2019 | ||||
| Actual Primary Completion Date | July 16, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 7 Years to 17 Years (Child) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04016701 | ||||
| Other Study ID Numbers ICMJE | Floreo Salus Protocol 1 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Floreo, Inc. | ||||
| Study Sponsor ICMJE | Floreo, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Floreo, Inc. | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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