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

Phase 2

Completed

• Conditions: Brain Injuries
• Interventions: Behavioral: Advocacy training curriculum; Behavioral: Self-directed

• Registration Number: NCT01002677
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curriculum	Advocacy training curriculum	-
Self-directed	Self-directed	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Brain Injury Association of Wisconsin; 🇺🇸 Pewaukee, Wisconsin, United States

Brain Injury Association of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Brain Injury Association of Iowa; 🇺🇸 Urbandale, Iowa, United States