Status:
COMPLETED
Treatment of Social Competence After Traumatic Brain Injury
Lead Sponsor:
Craig Hospital
Collaborating Sponsors:
Rehabilitation Hospital of Indiana
Hunter Holmes McGuire VA Medical Center
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to determine the effectiveness of holistic group treatment program (called Group Interactive Structured Treatment, or GIST) to improve social communication skills for individu...
Detailed Description
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 oth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT01465269
Start Date
July 1 2012
End Date
March 1 2015
Last Update
July 29 2015
Active Locations (6)
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1
Polytrauma Rehabilitation Center
Palo Alto, California, United States, 94304
2
Craig Hospital
Englewood, Colorado, United States, 80113
3
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46202
4
Rehabilitation Institute of Michigan
Detroit, Michigan, United States, 48201