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Problem Solving for Caregivers of Persons With Brain Injury

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Centers for Disease Control and Prevention.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: September 14, 2005
Last Update Posted: April 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centers for Disease Control and Prevention

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.

Condition Intervention Phase
Traumatic Brain Injury Behavioral: Problem Solving intervention Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Official Title: Problem Solving for Caregivers of Patients With Traumatic Brain Injury

Resource links provided by NLM:

Further study details as provided by Centers for Disease Control and Prevention:


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164645

Contact: Patricia Rivera, PhD 205-934-3464 rivera@uab.edu

United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Patricia Rivera, PhD    205-934-3463    rivera@uab.edu   
Sponsors and Collaborators
Centers for Disease Control and Prevention
Principal Investigator: Timothy R Elliot, PhD, ABPP University of Alabama at Birmingham
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00164645     History of Changes
Other Study ID Numbers: CDC-NCIPC-00019101
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: April 27, 2006
Last Verified: September 2005

Keywords provided by Centers for Disease Control and Prevention:
Emotional outcomes
health outcomes
traumatic brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System