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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: VR Social Skills

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krestin Radonovich, PhD; Phone Number: 304-598-4300; Email: krestin.radonovich@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26508
      • West Virginia University
      • Contact: Krestin Radonovich, PhD; Phone Number: 304-598-4300; Email: krestin.radonovich@hsc.wvu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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).

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline to 1 week post final treatment visit

Collaborators and Investigators

• Sponsor: West Virginia University
• Collaborators: Floreo
• Investigators: Principal Investigator: Krestin Radonovich, PhD, West Virginia University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 2304763205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No