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Problem Solving for Caregivers of Persons With Brain Injury

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clinicaltrials.gov/study/NCT00164645
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT001646450
Health Conditions in Trial
Traumatic brain injury
Traumatic brain injury
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Trial Sponsor
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
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Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Educational/Counseling/Training0
Interventional Trial Phase
Phase 30
Participating Facility
University of Alabama at Birmingham
University of Alabama at Birmingham
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Official Name
Problem Solving for Caregivers of Patients With Traumatic Brain Injury0
Last Updated
April 27, 2006
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Allocation Type
Randomized0
Intervention Model
Single Group Assignment0
Masking Type
Single0
Study 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.

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