Autism Spectrum DisorderPhase 2NCT04016701
VR for Joint Attention Support in ASD
A Phase 2 study testing Floreo Joint Attention Module and Regularly Scheduled Therapy in people with Autism Spectrum Disorder, run by Floreo, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Floreo Joint Attention Module and Regularly Scheduled Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2018to 16 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Documented ASD diagnosis, between 7 and 17 years of age
Who cannot join
- History of seizures, migraines, vertigo, psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immersive VR as a Tool to Support Joint Attention Skills in Children With Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Floreo Joint Attention Module, Regularly Scheduled Therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floreo Joint Attention ModuleDevice
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
Regularly Scheduled TherapyBehavioural
therapy as regularly scheduled at therapy center
| Study group | Role | What they receive |
|---|---|---|
| VR Intervention | Experimental | Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week Receives: Device: Floreo Joint Attention Module |
| Treatment as Usual | Active comparator | Regularly scheduled therapy Receives: Behavioral: Regularly Scheduled Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Joint Attention Protocol score at 12 weeks
A measure developed to rate child behaviors on 16 items involving response to joint attention and initiation of joint attention
Measured: immediately before and 4 weeks after intervention or control period of the study
Secondary outcomes (2)
Change from Baseline Joint Attention Assessment score at 12 weeks
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.
Measured: immediately before and 4 weeks after intervention or control period of the study
Change from Baseline Vineland Adaptive Behavior Scales, Third Edition total score
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.
Measured: immediately before and 4 weeks after intervention or control period of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start20 Jul 2018
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Why it stopped: limited recruitment within study timeline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Floreo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016701
- Sponsor's protocol ID
- Floreo Salus Protocol 1
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive VR as a Tool to Support Joint Attention Skills in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04016701
- Acronym / sponsor ID
- Floreo Salus Protocol 1
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: limited recruitment within study timeline
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Floreo, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Intervention | Experimental | Device: Floreo Joint Attention ModuleEight weeks of training with Floreo's VR Joint Attention Module with two sessions per week |
| Treatment as Usual | Active comparator | Behavioral: Regularly Scheduled TherapyRegularly scheduled therapy |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Documented ASD diagnosis, between 7 and 17 years of age
Key exclusion criteria (1 listed)
- History of seizures, migraines, vertigo, psychosis
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 |
|---|---|---|
| Floreo Joint Attention ModuleTwo 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 | Device | VR Intervention |
| Regularly Scheduled Therapytherapy as regularly scheduled at therapy center | Behavioural | Treatment as Usual |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Floreo Joint Attention Module and Regularly Scheduled Therapy in people with Autism Spectrum Disorder, run by Floreo, Inc. 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Jul 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 from Baseline Joint Attention Protocol score at 12 weeks (time frame: immediately before and 4 weeks after intervention or control period of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2019.