Lead Center:The Texas TBI Model System of TIRR
Principal Investigator Name:Margaret A. Struchen
Principal Investigator Email:firstname.lastname@example.org
Target Population(s):Persons with TBI who have social communication impairments
Overview â€¢ This study is a clinical trial of a treatment designed to improve social communication skills after traumatic brain injury (TBI). â€¢ Persons with TBI who have completed inpatient brain injury rehabilitation, are approximately one year after their injury and show evidence of social communication difficulties after their injury may be eligible to participate in this clinical trial. â€¢ Ratings of social communication performance by independent raters, persons with TBI and close others of persons with TBI will be compared between persons receiving the social communication treatment and persons on a wait-list to participate in the treatment. â€¢ In addition, the two groups will be compared with regard to reported loneliness, symptoms of depression, extent of social integration and overall life satisfaction. Changes in social communication abilities are fairly common after moderate to severe TBI. Social communication abilities include the knowledge of verbal and nonverbal communication skills and the ability to apply that knowledge in real-world situations. Difficulties with social communication after TBI can include such problems as having trouble starting conversations, having trouble staying â€œon-topic,â€ being overly talkative, having difficulty selecting conversation topics for the setting (like being too personal), or talking much more slowly. Social communication changes after TBI may be relatively minor, such as having difficulty with finding the words to use in conversation. Or, communication changes may be fairly large to the extent that others may describe the persons with TBI as having a â€œdifferent personalityâ€ after injury. Social communication competence plays a key role in the successful reintegration into home, work and school following TBI and is particularly important in the establishment of new friendships and maintenance of personal relationships after injury. Therefore, interventions that address social communication difficulties are of key importance in the rehabilitation of persons with traumatic brain injury (TBI). Despite the substantial body of research conducted since the late 1970s that has reported both that social communication abilities are commonly affected and that decreases in social integration occur after TBI, the number of empirical studies that have examined the effectiveness of social communication interventions in this population is surprisingly small. While there have been several case studies and small group studies, only two randomized clinical trials (RCT) have been conducted to look at the effectiveness of social communication interventions after brain injury. Although RCTs are not the only way to establish the usefulness of a treatment, many consider this type of study to be the â€œgold standardâ€ for establishing such evidence. One of the two published RCT studies utilized a method called Interpersonal Process Recall to treat social communication problems after TBI (Helffenstein & Wechsler, 1982). Treatment sessions for the IPR group consisted of participation in a videotaped interaction; structured review of the taped interaction with feedback provided by self, conversational partner and therapist; development of an alternative skill; modeling; and rehearsal. At post-treatment assessment, persons receiving the IPR treatment reported significantly reduced anxiety and improved self-concept. More importantly, those receiving the IPR intervention were rated to have significantly greater improvement in specific interpersonal skills by professional staff and independent observer raters, both of whom were unaware of the treatment condition to which the individuals had been assigned. Communication improvements were maintained at a one-month follow-up period. The current randomized clinical trial at TIRR Memorial Hermann is focused on replicating and extending the results of the Helffenstein and Wechsler (1982) study, using refined methodology. Some of the changes that have been implemented include: â€¢ Recruiting a much larger sample of participants with TBI (192 individuals, all of whom are at one year post-injury) â€¢ Using measures that have been developed specifically for persons with brain injury as key outcome rating scales â€¢ Examining various secondary outcomes (impact on emotional functioning, social integration, life satisfaction, and awareness) â€¢ Decreasing the number of treatment sessions to make the intervention more practical in a clinical setting â€¢ Using a deferred-treatment control (so that all participants may receive the treatment), and extending the follow-up period to 3-months after treatment â€¢ Utilizing a community-based conversation sample, as well as self- and family member/friend-ratings to test aspects of generalizability of treatment gains. A randomized clinical trial is one way of testing how well a given treatment or intervention works. For this social communication intervention study, what this means is that a person with TBI who meets criteria to obtain the treatment will have an equal chance (randomly assigned like the flip of a coin) of being assigned to receive the social communication treatment right away or will be assigned to a wait list (deferred treatment) and can receive the social communication intervention after a six-month waiting period. This type of study allows researchers to compare outcomes between those who got the treatment and those who have not yet had the treatment to see if the treatment had a beneficial effect. This study will compare how people do during and after the IPR intervention to those who haven't had the chance to participate in the IPR intervention. We will be comparing these two groups on several things, including: â€¢ Ratings of social communication performance as measured by ratings of communication behaviors by trained independent observers â€¢ Ratings of communication behaviors by the persons with TBI and either a family member or friend â€¢ Loneliness â€¢ Symptoms of depression â€¢ Social integration â€¢ Life satisfaction We anticipate that persons who complete the IPR intervention will show improvements in ratings of social communication behaviors, reductions in loneliness and depressive symptoms and improvements in social integration and life satisfaction.