Evaluation of an Intervention Model for Family Crisis and Support

NCT ID: NCT00205530

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury Brain Injury, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BIFI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

U.S. Department of Education

FED

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffrey S Kreutzer, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H133A020516

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H133A070036

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H133A02051604

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.