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Evaluation of an Intervention Model for Family Crisis and Support

This study is currently recruiting participants.
Verified by Virginia Commonwealth University, June 2008

Sponsors and Collaborators: Virginia Commonwealth University
Department of Education
Information provided by: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00205530
  Purpose

To learn more about how a family treatment program helps people after brain injury. Specifically, do families feel better and function better after going through the program, and do patients feel better and function better after going through the program.


Condition Intervention
Traumatic Brain Injury
Brain Injury, Chronic
Behavioral: Brain Injury Family Intervention (BIFI)

MedlinePlus related topics:   Head and Brain Injuries   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Evaluation of an Intervention Model for Family Crisis and Support (a Research Project Within the Traumatic Brain Injury Model System Grant)

Further study details as provided by Virginia Commonwealth University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   200
Study Start Date:   January 2003
Estimated Study Completion Date:   August 2012

Intervention Details:
    Behavioral: Brain Injury Family Intervention (BIFI)
    The Brain Injury Family Intervention (BIFI) was developed over the last decade based upon considerable clinical experience and research review. The BIFI is a structured approach to helping families address their most common and salient issues, concerns, and challenges. The BIFI is implemented in five 90-minute sessions.
Detailed Description:

To evaluate the efficacy of a structured outpatient family intervention program (BIFI) on family members' emotional well being, life satisfaction, needs, and family functioning; and to evaluate the impact of the BIFI on the emotional well being, life satisfaction, functional independence, vocational status, and neurobehavioral functioning of persons with acquired brain injury (ABI).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Study Population

Family members/caregiver friends and persons with ABI who are at least three months postinjury will be eligible to participate in the present investigation. ABI is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, non-progressive brain tumor, infection, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (PTA), objective neurological findings, or skull fracture. Penetrating wounds fitting the definition listed above will be included. Lacerations and/or bruises of the scalp or forehead without other criteria listed above will be excluded. All participants must be at least 18 years of age or older and able to understand and provide consent.


Criteria

Inclusion Criteria:

  • Family members/caregiver friends and persons with acquired brain injury (ABI) who are at least three months postinjury. ABI is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (PTA), objective neurological findings, or skull fracture.

Exclusion Criteria:

  • Families including individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators.
  • Individuals under 18 years of age.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205530

Contacts
Contact: Jennifer H Marwitz, MA     804-828-3704     jhmarwit@vcu.edu    

Locations
United States, Virginia
Virginia Commonwealth University     Recruiting
      Richmond, Virginia, United States, 23298
      Contact: Jennifer H Marwitz, MA     804-828-3704     jhmarwit@vcu.edu    
      Principal Investigator: Jeffrey S Kreutzer, PhD            

Sponsors and Collaborators
Virginia Commonwealth University
Department of Education

Investigators
Principal Investigator:     Jeffrey S Kreutzer, PhD     Virginia Commonwealth University    
  More Information


Virginia Commonwealth University Traumatic Brain Injury Model System  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Virginia Commonwealth University ( Jeffrey S. Kreutzer )
Study ID Numbers:   H133A02051604, H133A020516, H133A070036
First Received:   September 12, 2005
Last Updated:   June 3, 2008
ClinicalTrials.gov Identifier:   NCT00205530
Health Authority:   United States: Federal Government

Keywords provided by Virginia Commonwealth University:
brain injury, family treatment  

Study placed in the following topic categories:
Craniocerebral Trauma
Brain Damage, Chronic
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries
Brain Injury, Chronic

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2008




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