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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VR Social Skills

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

4 Years - 131 Months (Child)All SexesDoes not accept 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.

Sites / Locations

West Virginia University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Floreo BSC

Arm 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).

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT06098768

First Posted

October 19, 2023

Last Updated

October 19, 2023

Sponsor

West Virginia University

Collaborators

Floreo

1. Study Identification

Unique Protocol Identification Number

NCT06098768

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2023 (Anticipated)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West Virginia University

Collaborators

Floreo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Floreo BSC

Arm Type

Other

Arm 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).

Intervention Type

Behavioral

Intervention Name(s)

VR Social Skills

Intervention Description

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.

Primary Outcome Measure Information:

Title

Autism Impact Measure (AIM)

Description

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.

Time Frame

Baseline to 1 week post final treatment visit

Title

Childhood Autism Rating Scale, 2nd Edition (CARS-2)

Description

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.

Time Frame

Baseline to 1 week post final treatment visit

Title

Vineland Scales of Adaptive Behavior, 3rd Edition (Vineland 3)

Description

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.

Time Frame

Baseline to 1 week post final treatment visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

131 Months

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Krestin Radonovich, PhD

Phone

304-598-4300

Email

krestin.radonovich@hsc.wvu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Krestin Radonovich, PhD

Organizational Affiliation

West Virginia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

West Virginia University

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26508

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Krestin Radonovich, PhD

Phone

304-598-4300

Email

krestin.radonovich@hsc.wvu.edu

Autism Spectrum Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial