Autism Spectrum DisorderNCT06098768
Parent Led Implementation of a VR Social Skills Training Program for Children With ASD
A study testing VR Social Skills in people with Autism Spectrum Disorder, run by West Virginia University at 1 site in United States.
Trial summary
The goal of this interventional trial is to establish training protocols to show feasibility of training parents and caregivers to administer the VR protocol. The primary objective is to evaluate the effects of treatment with Floreo Building Social Connections (BSC) on the AIM, a parent report survey that assesses… Read more about this study
- Who is it for?
- Ages 4 years to 131 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- VR Social Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2023to Jun 2024
- Phase
- Interventional
- 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 4 years to 131 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 be able to tolerate VR therapy in the judgement of parent or caregiver and study staff.
- Female participants must either be unable to become pregnant (e.g., premenarchal, surgically sterile, etc.) or agree to use a highly effective method of contraception (e.g., intrauterine device, oral contraceptives, condom or diaphragm with spermicides, contraceptive sponge) from 28 days before the Baseline Visit to 45 days after the last treatment session. Females of childbearing potential must have a negative urine human chorionic gonadotropin pregnancy test at the Screening Visit.
Who cannot join
- History of photosensitive epilepsy or demonstrated photoparoxysmal response on prior electroencephalogram.
- Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome) which is not adequately controlled by medication or other therapy.
- History of balance disorder including vertigo, motion sensitivity, or ataxia. Vestibular sensory deficits are not necessarily exclusionary.
- Primary sensory impairment (blindness, deafness).
- Motor disorder that would interfere with VR engagement.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26508
Krestin Radonovich, PhD, 304-598-4300, krestin.radonovich@hsc.wvu.edu
About this study
Official title: Effectiveness of Parent Led Implementation of a Virtual Reality Social Skills Training Program for Children With Autism Spectrum Disorder
The goal of this interventional trial is to establish training protocols to show feasibility of training parents and caregivers to administer the VR protocol. The primary objective is to evaluate the effects of treatment with Floreo Building Social Connections (BSC) on the AIM, a parent report survey that assesses core symptoms of ASD. The secondary objective is to explore the changes in social skills over time by using a multimethod outcomes battery. The Investigators will evaluate the effect of treatment with Floreo BSC on the Childhood Autism Rating Scales (CARS-2) in the study patient population. Additional secondary objectives include evaluation of the effects of treatment on adaptive skills as measured by the Vineland-3. Participants will be asked to complete questionnaires and utilize the VR program at clinic and at home.
- Conditions
- Autism Spectrum Disorder
- Being tested
- VR Social Skills
- 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.
VR Social SkillsBehavioural
The intervention will consist of two episodes of the Floreo BSC program, each lasting 4-5 minutes, according to a fixed program of episodes determined by the participant's color-coded group. VR episodes will be presented via the Floreo application downloaded onto an iPhone worn by the participant in the VR headset. The VR interaction will be controlled and operated via linked iPad.
| Study group | Role | What they receive |
|---|---|---|
| Floreo BSC | Other | Subjects and their caregiver will engage in the Floreo VR Building Social Connections VR sessions: three sessions per week, for 12 weeks. Each session will consist of 2 VR (Floreo BSC) lessons separated by a brief break, for a total of approximately 15 minutes of direct VR time over a 30-minute period. Treatment sessions will be scheduled over a 12-week period, with an allowance of up to 15 weeks for make-up sessions (e.g., illness or travel). Receives: Behavioral: VR Social Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Impact Measure (AIM)
Change in measure: The AIM is a 25-item parent questionnaire targeting sensitivity to change of core ASD symptoms (Kanne et al., 2014). The questionnaire uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact). 5-point Likert-type scale, once for frequency of a specific behavior of the dependent and once for impact of that behavior. Response options range from "never" to "always" for the frequency dimension and "not at all" to "severely" for the impact dimension. Higher domain and higher total scores indicate greater symptom severity (Houghton et al., 2019; Mazurek et al., 2018). Likewise, lower AIM scores indicate less severe symptomatology.
Measured: Baseline to 1 week post final treatment visit
Childhood Autism Rating Scale, 2nd Edition (CARS-2)
Change in score from Baseline up to 1 week post final treatment visit. The CARS2 total raw score range from 15 to 60. This scale is a behavior rating scale intended to diagnose autism. A total score of 15 indicates that an individual behavior is within normal limits, whereas a value of 60 indicates that the individual's behavior is severely abnormal.
Measured: Baseline to 1 week post final treatment visit
Vineland Scales of Adaptive Behavior, 3rd Edition (Vineland 3)
Change in Measure for The Vineland-3 which evaluates adaptive behavior in five different domains: Social, Communication, Daily Living Skills, and Motor (Sparrow et al., 2016). 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 higher the score, the better the adaptive level.
Measured: Baseline to 1 week post final treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Floreo
- Responsible party
- Principal investigator, Krestin Radonovich, West Virginia University
- Investigators
- Krestin Radonovich, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098768
- Sponsor's protocol ID
- 2304763205
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Parent Led Implementation of a Virtual Reality Social Skills Training Program for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06098768
- Acronym / sponsor ID
- 2304763205
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Floreo
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 25 Oct 2023 (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 goal of this interventional trial is to establish training protocols to show feasibility of training parents and caregivers to administer the VR protocol. The primary objective is to evaluate the effects of treatment with Floreo Building Social Connections (BSC) on the AIM, a parent report survey that assesses core symptoms of ASD. The secondary objective is to explore the changes in social skills over time by using a multimethod outcomes battery. The Investigators will evaluate the effect of treatment with Floreo BSC on the Childhood Autism Rating Scales (CARS-2) in the study patient population. Additional secondary objectives include evaluation of the effects of treatment on adaptive skills as measured by the Vineland-3. Participants will be asked to complete questionnaires and utilize the VR program at clinic and at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Floreo BSC | Other | Behavioral: VR Social SkillsSubjects and their caregiver will engage in the Floreo VR Building Social Connections VR sessions: three sessions per week, for 12 weeks. Each session will consist of 2 VR (Floreo BSC) lessons separated by a brief break, for a total of approximately 15 minutes of direct VR time over a 30-minute period. Treatment sessions will be scheduled over a 12-week period, with an allowance of up to 15 weeks for make-up sessions (e.g., illness or travel). |
Who may qualify
- Ages
- 4 years to 131 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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 be able to tolerate VR therapy in the judgement of parent or caregiver and study staff.
- Female participants must either be unable to become pregnant (e.g., premenarchal, surgically sterile, etc.) or agree to use a highly effective method of contraception (e.g., intrauterine device, oral contraceptives, condom or diaphragm with spermicides, contraceptive sponge) from 28 days before the Baseline Visit to 45 days after the last treatment session. Females of childbearing potential must have a negative urine human chorionic gonadotropin pregnancy test at the Screening Visit.
Key exclusion criteria (5 listed)
- History of photosensitive epilepsy or demonstrated photoparoxysmal response on prior electroencephalogram.
- Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome) which is not adequately controlled by medication or other therapy.
- History of balance disorder including vertigo, motion sensitivity, or ataxia. Vestibular sensory deficits are not necessarily exclusionary.
- Primary sensory impairment (blindness, deafness).
- Motor disorder that would interfere with VR engagement.
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 |
|---|---|---|
| VR Social SkillsThe intervention will consist of two episodes of the Floreo BSC program, each lasting 4-5 minutes, according to a fixed program of episodes determined by the participant's color-coded group. VR episodes will be presented via the Floreo application downloaded onto an iPhone worn by the participant in the VR headset. The VR interaction will be controlled and operated via linked iPad. | Behavioural | Floreo BSC |
Primary outcome
Autism Impact Measure (AIM)
Time frame: Baseline to 1 week post final treatment visit
Change in measure: The AIM is a 25-item parent questionnaire targeting sensitivity to change of core ASD symptoms (Kanne et al., 2014). The questionnaire uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact). 5-point Likert-type scale, once for frequency of a specific behavior of the dependent and once for impact of that behavior. Response options range from "never" to "always" for the frequency dimension and "not at all" to "severely" for the impact dimension. Higher domain and higher total scores indicate greater symptom severity (Houghton et al., 2019; Mazurek et al., 2018). Likewise, lower AIM scores indicate less severe symptomatology.
Childhood Autism Rating Scale, 2nd Edition (CARS-2)
Time frame: Baseline to 1 week post final treatment visit
Change in score from Baseline up to 1 week post final treatment visit. The CARS2 total raw score range from 15 to 60. This scale is a behavior rating scale intended to diagnose autism. A total score of 15 indicates that an individual behavior is within normal limits, whereas a value of 60 indicates that the individual's behavior is severely abnormal.
Vineland Scales of Adaptive Behavior, 3rd Edition (Vineland 3)
Time frame: Baseline to 1 week post final treatment visit
Change in Measure for The Vineland-3 which evaluates adaptive behavior in five different domains: Social, Communication, Daily Living Skills, and Motor (Sparrow et al., 2016). 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 higher the score, the better the adaptive level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
Related trials for Autism Spectrum Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
Recruiting
Impact of an E-Learning Coaching for Parents of Young Children With Autism
Autism Spectrum Disorder
Recruiting
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
Autism, Autism Spectrum Disorder
Recruiting
Word Learning From Parentese in Autistic Children
Autism, Autism Spectrum Disorder
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.
Krestin Radonovich, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Social Skills in people with Autism Spectrum Disorder, run by West Virginia University 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 5 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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krestin Radonovich, PhD (304-598-4300, krestin.radonovich@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Impact Measure (AIM) (time frame: Baseline to 1 week post final treatment visit). The study lists 3 primary outcomes in all. 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 25 Oct 2023; AzTrials last refreshed its copy on 30 Oct 2026.