Problem Solving for Caregivers of Persons With Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Centers for Disease Control and Prevention.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164645
First received: September 12, 2005
Last updated: April 26, 2006
Last verified: September 2005
  Purpose

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 Blind
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:

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164645

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

Locations
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
Investigators
Principal Investigator: Timothy R Elliot, PhD, ABPP University of Alabama at Birmingham
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00164645     History of Changes
Other Study ID Numbers: CDC-NCIPC-00019101
Study First Received: September 12, 2005
Last Updated: April 26, 2006
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 28, 2014