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

NCT ID: NCT06098768

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-06-30

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Floreo BSC

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).

Group Type: OTHER

VR Social Skills

Intervention Type: BEHAVIORAL

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.

Interventions

VR Social Skills

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 131 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Floreo

UNKNOWN

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Krestin Radonovich

Vice Chair of Research, Director of Pediatric Neuropsychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krestin Radonovich, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Central Contacts

Krestin Radonovich, PhD

Role: CONTACT

krestin.radonovich@hsc.wvu.edu

304-598-4300

Facility Contacts

Krestin Radonovich, PhD

Role: primary

krestin.radonovich@hsc.wvu.edu

304-598-4300

Other Identifiers

2304763205

Identifier Type: -

Identifier Source: org_study_id