An interventional study of Virtual Envrionment for Social Communication in Traumatic Brain Injury, sponsored by The University of Texas Health Science Center, Houston. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Other
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).
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's enrollment of 13 is below the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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.
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
Behavioral: Virtual Envrionment for Social Communication
Once the Virtual Envrionment for Social Communication 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
Perceived Usability as Assessed by the System Usability Scale (SUS)
Scores on the System Usability Scale (SUS) range from 0-100, with higher scores indicating greater usability (which is the desired outcome).
Time frame: about 1 week after the end of the intervention
Acceptability as Assessed by the Acceptability E-Scale
Scores on the Acceptability E-scale range from 6-30, with higher scores indicating greater acceptability (which is the desired outcome).
Time frame: about 1 week after the end of the intervention
Feasibility as Assessed by Participation Rate
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).
Time frame: from the start of the intervention to the end of the intervention (6 weeks)
Feasibility as Assessed by Attrition Rate
Time frame: from the start of the intervention to the end of the intervention (6 weeks)
Change in Social Communication as Assessed by the LaTrobe Communication Questionnaire (LCQ)
Time frame: baseline, about 1 week after the end of the intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2018 to primary completion in Jan 2019, 5 months.
Of 491 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's 5 months is below that.
Counting every sponsor, half of 515 studies reached it within 36 months; a quarter within 21 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston →