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| Name | Class |
|---|---|
| Cortica | UNKNOWN |
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A Randomized Controlled Phase II study to assess the efficacy of Floreo VR (Virtual reality) Building Social Connections as treatment for social skills in children with Autism Spectrum Disorder (ASD)
In this randomized controlled phase II study, 30 eligible subjects aged 4-10 years old with documented ASD diagnoses will be enrolled and randomized in a 1:1 ratio intervention vs control group.
The Floreo VR Building Social Connections intervention is designed to be administered for 12 weeks, with three treatment visits per week, for a total of 36 treatment visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Floreo VR Building Social Connections | Experimental | Participants will receive Floreo VR Building Social Connections lessons approximately 3 times a week for no more than 15 minutes per session. |
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| Sham | Sham Comparator | Participants will receive non-interventional active VR videos approximately 3 times a week for no more than 15 minutes per session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Floreo VR Building Social Connections | Device | Floreo's VR platform consists of a VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) that are seamlessly linked in real time, allowing the therapist (or monitor) to set up lessons, change the interactive environment, and provide live verbal and VR-based guidance, feedback, and rewards to users. The lessons that will be implemented in this intervention are aimed at targeting social skills such as communication, joint attention, and social interactions. |
| Measure | Description | Time Frame |
|---|---|---|
| Autism Impact Measure (AIM) Assessment | The AIM is a 25-item parent questionnaire targeting sensitivity to change of core ASD symptoms. The questionnaire uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact). The items cover distinct sub-domains of ASD symptoms including Repetitive Behavior, Atypical Behavior, Social Reciprocity, and Peer Interaction. A composite score is also calculated. | The AIM takes approximately 30 minutes to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| CARS-2 | The CARS-2 is a 15-item rating scale used to identify children with autism and determine overall symptom severity. The scale is completed by a clinician familiar with the assessment of ASD after collecting information by direct interview and observation. The rater will also make use of supplemental collected using an unscored Parent/Caregiver Questionnaire. Only the CARS-2 Standard rating scale will be used for the purposes of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| AIM sub-domain scores | The AIM is a 25-item parent questionnaire targeting sensitivity to change of core ASD symptoms. The questionnaire uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact). The items cover distinct sub-domains of ASD symptoms including Repetitive Behavior, Atypical Behavior, Social Reciprocity, and Peer Interaction. A composite score is also calculated. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cortica | Thousand Oaks | California | 91361 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23748386 | Background | Kanne SM, Mazurek MO, Sikora D, Bellando J, Branum-Martin L, Handen B, Katz T, Freedman B, Powell MP, Warren Z. The Autism Impact Measure (AIM): initial development of a new tool for treatment outcome measurement. J Autism Dev Disord. 2014 Jan;44(1):168-79. doi: 10.1007/s10803-013-1862-3. |
| Label | URL |
|---|---|
| Floreo Website | View source |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D003142 | Communication |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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The two parallel groups include an experimental group that will receive the Floreo VR Building Social Connections program and a control group that will receive non-interventional active VR programing.
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Subjects and their parents/caregivers will be blinded to whether they are receiving Floreo VR therapy vs active VR exposure control. Research staff administering the therapy or control will not be blinded to the therapy; however, the clinicians doing pre/post assessments will be blinded.
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| Sham | Device | This condition will contain the same VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) as the intervention condition, but instead of social skill lessons, only non-intervention, active VR videos such as underwater fish swimming will be shown. |
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| The CARS-3 takes approximately 5-10 minutes to complete after the information needed to make the ratings is collected |
| The AIM takes approximately 30 minutes to complete. |
| Vineland-3 Adaptive Behavior Composite and sub-domain scores | The Vineland-3 evaluates adaptive behavior in five different domains: Social, Communication, Daily Living Skills, and Motor. In the context of this study, it will be administered using the Comprehensive Interview Form, for which a parent or caregiver is interviewed by a qualified rater familiar with the instrument. Based on the summarized scores in each domain, an Adaptive Behavior Composite (ABC) is also calculated. Items are scored on a scale of 0 (never), 1 (sometimes), or 2 (usually) for the level at which the child can independently perform a skill. | The Vineland-3 Comprehensive Interview Form takes approximately 60-90 minutes to complete |
| Adverse events related to VR use | Parents or caregivers will be asked about adverse events at the baseline visit (if this is separate from the screening visit), interim visits 1 and 2, and at the end of study visit. The occurrence or absence of AEs, and a description of any AEs, will be recorded on an Adverse Events Form. | 5-10 minutes as needed to fill out AE form |
| Cortica Website | View source |