Evaluation of an Intervention Model for Family Crisis and Support

Completed

• Conditions: Traumatic Brain Injury; Brain Injury, Chronic

• Registration Number: NCT00205530
• Lead Sponsor: Virginia Commonwealth University

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.

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 Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States