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

NCT01002677 | Completed Phase 2

• 2 other identifiers: 08-000981H133A070013-09
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 3

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.

Conditions

Brain Injuries

Keywords

brain injury; traumatic brain injury; training; teaching; curriculum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

Study Arms (2)

Curriculum

EXPERIMENTAL

Behavioral: Advocacy training curriculum

Self-directed

ACTIVE COMPARATOR

Behavioral: Self-directed

Interventions

Advocacy training curriculum BEHAVIORAL

Day-long presentation of an advocacy training curriculum by the state's Brain Injury Association staff: One session per month for 4 consecutive months.

Curriculum

Self-directed BEHAVIORAL

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

Self-directed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• or more years post-injury
• Functional English speaker
• Signed consent to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Brain Injury Association of Iowa

Urbandale, Iowa, 50322, United States

Location

Brain Injury Association of Minnesota

Minneapolis, Minnesota, 55413, United States

Location

Brain Injury Association of Wisconsin

Pewaukee, Wisconsin, 53072, United States

Location

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Allen W Brown, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Brain Rehabilitation Research

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 27, 2009
• Study Start: August 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (3)