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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


NCT number NCT00164645
Study type Interventional
Source Centers for Disease Control and Prevention
Contact Patricia Rivera, PhD
Phone 205-934-3464
Email rivera@uab.edu
Status Recruiting
Phase Phase 3

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