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

Midwest Advocacy Project: A Community-based Randomized Practical Behavioral Trial of Programmed Advocacy Training for Individuals With Traumatic Brain Injury and Their Significant Others

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 Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Behavioral: Advocacy training curriculum; Behavioral: Self-directed

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Urbandale, Iowa, United States, 50322
      • Brain Injury Association of Iowa
  • Minnesota
    • Minneapolis, Minnesota, United States, 55413
      • Brain Injury Association of Minnesota
  • Wisconsin
    • Pewaukee, Wisconsin, United States, 53072
      • Brain Injury Association of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curriculum	Behavioral: Advocacy training curriculum; Day-long presentation of an advocacy training curriculum by the state's Brain Injury Association staff: One session per month for 4 consecutive months.
Active Comparator: Self-directed	Behavioral: Self-directed; Day-long group-based self-directed advocacy training activity: One session per month for 4 consecutive months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score on the Advocacy Behavior Rating Scale	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 Outcome Measures

Outcome Measure	Time Frame
Score on Advocacy Activity Scale	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	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	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	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	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	Every 6 months after intervention until the end of the 5-year study period

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Allen W Brown, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 22, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): January 17, 2013
• Last Update Submitted That Met QC Criteria: January 16, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: brain injury; traumatic brain injury; training; teaching; curriculum
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 08-000981; H133A070013-09