Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of an Intervention Model for Family Crisis and Support

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00205530
First received: September 12, 2005
Last updated: July 29, 2013
Last verified: July 2013
  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)

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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Family Needs Questionnaire (FNQ) [ Time Frame: pre-treatment, post-treatment, 3 mo. follow-up ] [ Designated as safety issue: No ]
    The Family Needs Questionnaire (FNQ) is a widely used 40-item self-report questionnaire developed to measure family members' perceived needs after a family member sustains a brain injury. The items were designed to address diverse psychosocial and educational needs apparent in the acute and post-acute phases after injury. Family members rate the degree to which they perceive that each need has been met (not met, partly met, or met). A factor analytic investigation revealed six independent factors comprising six scales: Health Information, Emotional Support, Instrumental Support, Professional Support, Community Support Network, and Involvement with Care. The proportion of needs described as met (converted to a 10 point scale) was the primary family outcome measure.


Enrollment: 160
Study Start Date: January 2003
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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.
    Other Name: BIFI
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
U.S. Department of Education
Investigators
Principal Investigator: Jeffrey S Kreutzer, PhD Virginia Commonwealth University
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00205530     History of Changes
Other Study ID Numbers: H133A02051604, H133A020516, H133A070036
Study First Received: September 12, 2005
Last Updated: July 29, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Brain Injuries
Brain Injury, Chronic
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014