Behavioral Trial Studying Programmed Training to Improve Advocacy Skills for Individuals With Traumatic Brain Injury (MAP)

Mayo Clinic

Status and phase

Completed

Phase 3

Phase 2

Conditions

Brain Injuries

Treatments

Behavioral: Self-directed

Behavioral: Advocacy training curriculum

Study type

Interventional

Funder types

Other

Identifiers

NCT01002677

08-000981

H133A070013-09

Details and patient eligibility

About

The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical behavioral trial of advocacy skill training for individuals with traumatic brain injury (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a 4-session advocacy training program to improve behavioral advocacy skills compared to self-directed advocacy training of the same session frequency. Groups will be randomly assigned to either a programmed group or a self-directed group in collaboration with the Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study period. The primary outcome is pre-post measures of written and verbal advocacy skill measured by the Advocacy Behavior Rating Scale.

It is hypothesized that subjects who receive programmed advocacy training will show greater positive change on pre-post measures of advocacy skill measures than subjects receiving self-directed training.

Enrollment

234 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older
moderate-severe TBI as indicated by one of the following:
post traumatic amnesia (PTA) > 24 hours
or loss of consciousness > 30 minutes
or neuroimaging evidence of trauma-related intracranial abnormality
Or the family/significant other of an individual with TBI meeting the above criteria
1 or more years post-injury
Functional English speaker
Signed consent to participate

Exclusion criteria

Severe cognitive impairment as indicated by one or more of the following:
Disorientation to person or year
Unable to complete pre-program interview because of severe communication limitations
Unable to remember important information given in the course of the pre-program interview, such as, time and place of program, number of sessions, and contact person
Unable to complete the pre-program interview because of loss of emotional control, such as, extended tearfulness, sustained anger, verbal attack on interviewer