Treatment of Social Competence After Traumatic Brain Injury

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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 individuals with Traumatic Brain Injury. Hypothesis: Compared to an alternative intervention, those receiving the GIST intervention will show improved social competence, improved quality of life, and stronger group cohesion.

Key facts

Study ID

NCT01465269

Run by

Craig Hospital

People needed

231

Starts

2012-07-01

Expected to finish

2015-03-01

Last updated by the study team

2015-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Polytrauma Rehabilitation Center — Palo Alto, California, United States
• Craig Hospital — Englewood, Colorado, United States
• Rehabilitation Hospital of Indiana — Indianapolis, Indiana, United States
• Rehabilitation Institute of Michigan — Detroit, Michigan, United States
• Hunter Holmes McGuire Medical Center — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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