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

Brain Injuries Clinical Trial

— MAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002677
• Other study ID #: 08-000981
• Secondary ID: H133A070013-09
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 22, 2009
• Last updated: January 16, 2013
• Start date: August 2007
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Brain Injuries

Intervention

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.
• Self-directed
Day-long group-based self-directed advocacy training activity: One session per month for 4 consecutive months.

Locations

Country	Name	City	State
United States	Brain Injury Association of Minnesota	Minneapolis	Minnesota
United States	Brain Injury Association of Wisconsin	Pewaukee	Wisconsin
United States	Brain Injury Association of Iowa	Urbandale	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Advocacy Activity Scale		Every 6 months after intervention until the end of the 5-year study period	No