Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT01465269
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01465269
Study Brief:
Protocol Section:
NCT01465269