Clinical trial NCT06098768: Parent Led Implementation of a VR Social Skills Training Program for Children With ASD
Official title: Effectiveness of Parent Led Implementation of a Virtual Reality Social Skills Training Program for Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: Floreo
First posted: 2023-10-25
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 131
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Autism Impact Measure (AIM)
timeFrame: Baseline to 1 week post final treatment visit
measure: Childhood Autism Rating Scale, 2nd Edition (CARS-2)
timeFrame: Baseline to 1 week post final treatment visit
measure: Vineland Scales of Adaptive Behavior, 3rd Edition (Vineland 3)
timeFrame: Baseline to 1 week post final treatment visit
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Krestin Radonovich, PhD
role: PRINCIPAL_INVESTIGATOR
References: