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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57815281
Enrollment
108
Registered
2007-05-10
Start date
2007-05-01
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury Injury, Occupational Diseases, Poisoning Traumatic brain injury

Interventions

A social-communication training program for people with TBI will be compared with another program designed for the everyday communication partners of people with TBI. 'The Social Comm

Sponsors

University of Sydney (Australia)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
All participants will be assessed on the following secondary outcome variables pre treatment, immediately post treatment and 6 months post treatment. 1. Discourse measures will provide a detailed analysis of the structure and flow of conversation between the person with TBI and their everyday communication partner. Analysis of the interactional 'exchange structure' between person with TBI and their Everyday Communication Partner during a problem solving task will provide a measure of who has the power in the conversation (by the role the participant takes in information giving). Analysis will also be completed on the 'Generic Structure Potential' of the conversation on the problem solving task. This examines the broader structural elements of a conversation. 2. Social skills measures will examine broader aspects of social skills including: a. Degree of "rewardingness" in a conversational interaction as judged on a 9 point scale by blind raters b. Global ratings of participants' self esteem, measured with the Rosenberg Self-Esteem Scale and the Coopersmith Inventory c. Social perception ability, measured by the total score on the Awareness of Social Inference Test (TASIT). This test requires the person with TBI to interpret the emotion of speakers engaged in everyday conversations (as depicted on videotape) as well as the meaning and intentions behind their specific comments, some of which are not literally true (i.e. lies or sarcastic comments) d. Global ratings of the contributions made by the communication partners in conversation will be measured by the score on the Measure of Skill in Supported Conversation e. Perceived communicative ability from the point of view of both person with TBI and their everyday communication partner, will be measured with the average score on the Latrobe Communication Questionnaire (LCQ)

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026