Improving the communication of people with severe Traumatic Brain Injury (TBI): a clinical trial

Not Applicable

Completed

• Conditions: Traumatic brain injury; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN57815281
• Lead Sponsor: niversity of Sydney (Australia)

Brief Summary

1. 2009 protocol in: https://doi.org/10.1375/brim.10.2.188 (added 23/05/2019) 2. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23803687 (added 23/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-10
• Study Completion: 2009-12-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

Participants must:
1. Have sustained a moderate to severe TBI for at least 9 months, previously defined as a score on the Glasgow Coma Scale (GCS) of 9 -12 (moderate), 8 or less (severe) and/or a period of Post Traumatic Amnesia (PTA) of 1-24 hours (moderate) or more than 24 hours (severe). GCS and PTA is routinely assessed at the participating centers and recorded in hospital files
2. Be observed by ward or community staff to have significant social skills deficits
3. Be of at least average pre-morbid intelligence (as assessed on the WAISIII Vocabulary subtest and demographic information)
4. Have a regular communication partner with whom they interact on a daily basis

Family members or care-givers will be familiar to the person with TBI, have not sustained a brain injury or have a psychiatric history, and interact with the person with TBI on a regular basis.

Exclusion Criteria

1. Drug and alcohol addiction or active psychosis as defined by their treating doctor
2. Aphasia (language impairment) as assessed by their speech pathologist
3. Non-English speaking background
4. Severe amnesia, as assessed by Wechsler Memory Scale
5. Severe dysarthric (motor speech) impairments which make speech unintelligible

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of Participation in Conversation: The primary measure will evaluate the person with TBI's level of participation in conversation in terms of his/her ability to interact or socially connect with a partner and to respond to and/or initiate specific content. The rater scores a 5-minute videotape of a social interaction between the person with TBI and their significant other on a 9-point Likert scale, presented as a range of 0 to 4 with 0.5 levels for ease of scoring. The scale ranges from 0 (no participation) through 2 (adequate participation) to 4 (full participation in conversation). Two independent blind raters will score the videotapes. All participants will be assessed on the primary outcome variables pre treatment, two times during treatment, immediately post treatment and 6 months post treatment.