Traumatic Brain Injury Clinical Trial
Official title:
Problem Solving for Caregivers of Patients With Traumatic Brain Injury
| NCT number | NCT00164645 |
| Other study ID # | CDC-NCIPC-00019101 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | September 12, 2005 |
| Last updated | April 26, 2006 |
Family caregivers of persons with traumatic brain injury (TBI) have long-term demands that
tax their coping abilities and adversely affect their health and well-being. This project
will test the effectiveness of a problem-solving training program tailored to the unique
needs of family caregivers of persons with TBI. Over a 3-year period, family caregivers and
their care recipients will be recruited and randomly assigned to a problem-solving
intervention group (n=40 dyads) or a control group (n=40 dyads). Participants in the
problem-solving intervention group will receive four face-to-face problem-solving training
sessions and monthly telephone problem-solving sessions over the course of 1 year. Control
group participants will receive a handbook of educational materials and a staff member will
contact each control group participant monthly by telephone to review these materials and
other informational needs. No problem-solving training will be provided to control
participants throughout the year.
Caregivers and care recipients will be assessed at four points during their participation:
at the initial assessment, at 4 months, at 8 months, and at the completion of the 1-year
participation period. All evaluations will be conducted in the participants' homes. Measures
of problem-solving ability, caregiver burden, and adjustment (depression, health,
satisfaction with life) will be collected. Structural equation modeling and other
regression/inferential analyses will be used to determine the effects of problem solving on
caregiver adjustment over time after taking into account care recipient adjustment and
caregiver ethnicity. This project will: (1) demonstrate how specified physical and emotional
outcomes of caregivers and care recipients are related to caregiver problem-solving
abilities and how these relationships vary as a function of time; (2) evaluate the
effectiveness of a community-based, problem-solving intervention that will be delivered to
caregivers; and (3) identify caregivers and care recipients with TBI who are at risk for
adverse emotional and health outcomes.
| Status | Recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: Minimum age of 19 years Brain injury diagnosis at least 6 mos in-house non-paid caregiver of person with brain injury functional literacy caregiver willing to discuss abuse issues Exclusion Criteria: |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| Centers for Disease Control and Prevention |
United States,
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