Bridging Recovery Allies in Virtual Environments

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: Virtual Envrionment for Social Communication

• Registration Number: NCT03582228
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The Bridging Recovery Allies in Virtual Environments (BRAVE) study aims to evaluate the acceptability and feasibility of implementing a virtual environment (VE) social support group for social communication training among adults with traumatic brain injury (TBI).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-07-10
• Study Start: 2018-08-06
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• subjects with a traumatic brain injury
• between the age of 18 and 80
• living in the community
• able to read and speak English,
• are more than 1-year post-injury
• are accessible by phone,
• report independent computer usage over the last 6 months
• have access to a computer meeting minimum specifications for the Learning in Virtual Environments (LIVE) platform (requires Windows)
• have broadband Internet connection,
• achieve a Galveston Orientation Assessment Test (GOAT) score >75 to ensure appropriate levels of cognition for the study
• and score >93.8 on the Western Battery Aphasia-Revised (WAB-R) scale to indicate sufficient communicative abilities to participate in a social support group and exit interview group.
• able to understand and independently consent for the study and provide written consent prior to enrollment in the study

Exclusion Criteria

• verbal communication impairments will be excluded as measured by the WAB-R, as this study intends to focus on persons with social communication deficits rather than verbal deficits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Envrionment for Social Communication	Virtual Envrionment for Social Communication	Once the intervention begins, participants will meet online from home for one-hour sessions twice a week (twelve sessions over six weeks). Weekly sessions will follow a standardized format: * 15 minutes- Social support group (guided discussion of experiences related to weekly topic) * 20 minutes- Didactic instruction * 15 minutes- Role playing * 10 minutes- Debriefing and group feedback

Primary Outcome Measures

Name	Time	Method
Perceived Usability as Assessed by the System Usability Scale (SUS)	about 1 week after the end of the intervention	Scores on the System Usability Scale (SUS) range from 0-100, with higher scores indicating greater usability (which is the desired outcome).
Acceptability as Assessed by the Acceptability E-Scale	about 1 week after the end of the intervention	Scores on the Acceptability E-scale range from 6-30, with higher scores indicating greater acceptability (which is the desired outcome).
Feasibility as Assessed by Participation Rate	from the start of the intervention to the end of the intervention (6 weeks)	Scores on the LaTrobe Social Communication Questionnaire (LCQ) range from 30-120, with lower score indicating less social communication impairment (which is the desired outcome).
Feasibility as Assessed by Attrition Rate	from the start of the intervention to the end of the intervention (6 weeks)

Secondary Outcome Measures

Name	Time	Method
Change in Social Communication as Assessed by the LaTrobe Communication Questionnaire (LCQ)	baseline, about 1 week after the end of the intervention

Trial Locations

Locations (2)

TIRR Memorial Hermann; 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States