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Completed

NCT Number: NCT05791071

Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)

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)

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Mental Disorders Neurodevelopmental Disorders

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cortica

Thousand Oaks, California, 91361, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females aged 4 years to 10 years 11 months of age (up to 11th birthday at randomization).
  • Patients or legally authorized representatives must provide written informed consent and be willing and able to comply with study procedures. Participants must provide informed assent as clinically appropriate.
  • A diagnosis of autism spectrum disorder on the basis of the clinical judgement of a qualified clinician according to DSM-5 criteria, supported by either the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
  • Participants must receive ABA therapy at Cortica, with scheduled ABA sessions in clinic at least 3 times per week.
  • Participants must be able to tolerate VR therapy in the judgement of parent or caregiver and study staff

Exclusion criteria

  • A history of photosensitive epilepsy, or photoparoxysmal response on electroencephalogram (EEG)
  • Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome), not adequately controlled
  • History of balance disorder including vertigo, motion sensitivity, or balance disorder
  • Primary sensory impairment (blindness, deafness)
  • Motor disorder that would interfere with VR engagement

Treatment and study plan

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.

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.

Primary outcomes

  1. Autism Impact Measure (AIM) Assessment

    Time frame: The AIM takes approximately 30 minutes to complete.

    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.

Secondary outcomes

  1. CARS-2

    Time frame: The CARS-3 takes approximately 5-10 minutes to complete after the information needed to make the ratings is collected

    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.

Other outcomes

  1. AIM sub-domain scores

    Time frame: The AIM takes approximately 30 minutes to complete.

    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.

  2. Vineland-3 Adaptive Behavior Composite and sub-domain scores

    Time frame: The Vineland-3 Comprehensive Interview Form takes approximately 60-90 minutes to complete

    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.

  3. Adverse events related to VR use

    Time frame: 5-10 minutes as needed to fill out AE form

    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.

Sponsors and collaborators

Lead sponsor

Floreo, Inc.

Industry

Collaborators

  • Cortica

Registry information

Official study title

A Randomized Controlled Phase II Study to Assess the Efficacy of Floreo VR Building Social Connections vs. Active VR Exposure Control as Treatment for Social Skills in Autistic Children

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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