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

Mayo Clinic234 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

234

Conditions

Brain Injuries

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Brain Injury Association of Iowa

Urbandale, Iowa, United States

Brain Injury Association of Minnesota

Minneapolis, Minnesota, United States

Brain Injury Association of Wisconsin

Pewaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Score on the Advocacy Behavior Rating Scale

Time frame: Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.

Secondary Outcomes

Score on Advocacy Activity Scale

Time frame: The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.

Score on the Perceived Control Scale for Brain Injury

Time frame: The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.

The Craig Hospital Inventory of Environmental Factors-Short Form

Time frame: The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.

The Satisfaction with Life Scale

Time frame: The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.

The SF-12

Time frame: The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.

Advocacy Activity Scale

Time frame: Every 6 months after intervention until the end of the 5-year study period