Parent Led Implementation of a VR Social Skills Training Program for Children With ASD

West Virginia University

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: VR Social Skills

Study type: Interventional

Funder types: Other

Identifiers

NCT06098768

2304763205

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 4 years to 131 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Floreo BSC

Other group

Description:

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).

Treatment:

Behavioral: VR Social Skills