Evaluation of an Intervention Model for Family Crisis and Support

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: BIFI

Primary outcomes

Family Needs Questionnaire (FNQ)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

U.S. Department of Education

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2013
Study completion: 2013
First posted: Sep 20, 2005
Registry last updated: Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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