Evaluation of an Intervention Model for Family Crisis and Support

Traumatic Brain Injury Clinical Trial

Official title:

Evaluation of an Intervention Model for Family Crisis and Support (a Research Project Within the Traumatic Brain Injury Model System Grant)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205530
• Other study ID #: H133A02051604
• Secondary ID: H133A020516H133A
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: July 29, 2013
• Start date: January 2003
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury, Chronic
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family Needs Questionnaire (FNQ)	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.	pre-treatment, post-treatment, 3 mo. follow-up	No

External Links

•   Virginia Commonwealth University Traumatic Brain Injury Model System