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

NCT06098768 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-10-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Floreo

    collaborator UNKNOWN
  • West Virginia University

    lead OTHER

Principal Investigators

  • Krestin Radonovich, PhD · West Virginia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
131 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06098768 on ClinicalTrials.gov