Evaluation of an Intervention Model for Family Crisis and Support

NCT00205530 | Completed

• 3 other identifiers: H133A02051604H133A020516H133A070036
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Brain Injury, Chronic

Keywords

brain injury, family treatment

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Brain Injury Family Intervention (BIFI) BEHAVIORAL

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.

Also known as: BIFI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injury, Chronic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey S Kreutzer, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2003
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 31, 2013

Record last verified: 2013-07

Locations

US (1)