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NCT Number: NCT01002677

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Brain Injury Association of Iowa, Urbandale, Iowa, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Self-directed

Behavioral

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Advocacy Activity Scale

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Acronym: MAP

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 27, 2009
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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