Clinical trial NCT00164645: Problem Solving for Caregivers of Persons With Brain Injury
Official title: Problem Solving for Caregivers of Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Traumatic Brain Injury
Keywords: Emotional outcomes
health outcomes
traumatic brain injury
caregiving
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief 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.


Eligibility criteria: 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:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Timothy R Elliot, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References: