Evaluation of an Intervention Model for Family Crisis and Support

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT00205530
Collaborator
U.S. Department of Education (U.S. Fed)
160
1
120
1.3

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Brain Injury Family Intervention (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).

Study Design

Study Type:
Observational
Actual Enrollment :
160 participants
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)
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Family Needs Questionnaire (FNQ) [pre-treatment, post-treatment, 3 mo. follow-up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00205530
Other Study ID Numbers:
  • H133A02051604
  • H133A020516
  • H133A070036
First Posted:
Sep 20, 2005
Last Update Posted:
Jul 31, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Virginia Commonwealth University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 31, 2013