Treatment of Social Competence After Traumatic Brain Injury

Background: Impairments in social competence are among the most prevalent sequelae after
traumatic brain injury (TBI). Without successful social skills a person is often isolated,
in conflict with others, and denied access to social and vocational opportunities. The aim
of this study is to determine the effectiveness of a manualized group treatment program to
improve and maintain social competence for individuals with TBI with identified social skill
deficits. The Group Interactive Structured Treatment (GIST) - Social Competence program is a
holistic, dual-disciplinary intervention targeting the pervasive interpersonal and
communication problems that often interfere with participation at work, home, school and in
the community after TBI.

Aims and Hypotheses: Aim 1: Measure the effectiveness of the GIST intervention with
multisite implementation. Hypothesis 1a: Those receiving the GIST will demonstrate
significant improvement in social competence, compared to those receiving the alternative
treatment, as measured by the Profile of Pragmatic Impairment in Communication (PPIC).
Hypothesis 1b: Compared to the alternative intervention, those receiving the GIST will
maintain improvement in social competence at 3 months post-intervention, as measured by the
PPIC. Hypothesis 1c: Compared to the alternative intervention, those receiving the GIST will
demonstrate improvement in additional aspects related to social competence at 3 months
post-intervention, as measured by the LaTrobe Communication Questionnaire, the Goal
Attainment Scale, the Brief Symptom Inventory-18, and the Post Traumatic Stress Disorder
Check List - Civilian version. Hypothesis 1d: Compared to the alternative intervention,
those receiving the GIST will demonstrate improvement at 3 months post intervention in
quality of life, as measured by the Satisfaction with Life Scale. Aim 2: Identify the potent
ingredients associated with the GIST. Hypothesis 2a: FOr participants in the GIST
intervention, higher group cohesion measured by the TFI: Cohesiveness Scale will be
associated with improved social competence. Hypothesis 2b: Compared to the alternative
intervention, those receiving the GIST will demonstrate stronger social self efficacy
associated with improved social competence, as measured by the Scale of Perceived Self
Efficacy.

Study Design: This study uses a two-arm, multi-centered randomized controlled clinical trial
design to compare the GIST treatment to an alternative treatment, in which participants are
presented information from the GIST treatment program without the group process. A total of
192 military, veteran and civilian participants with mild to moderate TBI will be enrolled
by six centers. Measures will be collected at baseline, post-treatment, and 3 months
post-treatment. Videotapes of participants will be evaluated for social competence by
blinded independent raters, and progress on individualized social skills goals will be
assessed. Replicable training of group leaders will include a 2 ½ day in-person workshop
followed by feedback during a pilot of the intervention and alternative intervention. The
fidelity of the intervention will be assessed by independent raters using a standardized
instrument to ensure that the intervention is implemented consistently. Results of this
study will be disseminated to relevant stakeholders via presentations and publications. By
the end of this study, the field will have definitive evidence about the effectiveness of a
group social competence intervention for people with TBI.

Military Benefit: The proposed study has a high degree of relevance for returning OIF/OEF
soldiers and veterans post-TBI due to the prevalence of social reintegration difficulties in
this population. The GIST intervention has the potential to assist our soldiers and veterans
in returning to full participation in their families, communities and productive activity.

Inclusion Criteria:

- Have a history of a TBI as evidenced by self report on OSU TBI ID screen

- Sustained a TBI anytime after October 2001;

- are at least 6 months post injury

- score at Level 1 (Independent) or Level 2 (Overnight Supervision) on the Supervision
Rating Scale;

- are 18 years of age or older at the time of the study;

- have adequate receptive/expressive communication skills functional for group
participation, (score >5 on the Comprehension and Expression of the Functional
Independence Measure (FIM)70 based on results of screening interview;

- possess the English language skills necessary to participate in the group
intervention and complete study measures;

- demonstrate some aspect of problematic social competence by responding "yes" to at
least one of 5 screening statements listed here, as reported by the participant or
their support person.

- provide Informed Consent to participate.

Exclusion Criteria:

- are unable to verbally communicate, or require augmentative communication system;

- are unable to attend the majority of group sessions (e.g., living at a distance from
the site without consistent transportation; going on an extended vacation, planned
surgeries, planning to move);

- are currently involved in ongoing structured group psycho-social therapy;

- are currently participating in another clinical trial.

- are currently in one-on-one therapy with one of the therapists

- have already participated in the GIST intervention

- in the opinion of the PI, have any conditions which might interfere with complete of
the study protocol.