Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effectiveness of an Adaptive Treatment Model for At-risk Family Caregivers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00632684
First received: March 7, 2008
Last updated: November 22, 2011
Last verified: April 2009
  Purpose

This study will develop and evaluate the effectiveness of an adaptive treatment model for reducing the stress of, and burden on, family members caring for a person with dementia.


Condition Intervention
Stress
Behavioral: Interviews with a single treatment planning session
Behavioral: Adaptive treatment model

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptive Intervention for At-risk Family Caregivers

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Role overload [ Time Frame: Measured immediately after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nine-Item Depression Scale of the Patient Health Questionnaire (PHQ-9) [ Time Frame: Measured immediately after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: July 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants in Phase 1 will undergo four interviews, including a single treatment planning session.
Behavioral: Interviews with a single treatment planning session
Participants in Phase 1 will attend four 90-minute interviews over 4 months. During interviews, participants will be asked about their experiences caring for their relatives, physical and emotional well-being, and ideas on helpful types of assistance. Participants will also receive information about programs and services that may help them carry out caregiving activities.
Experimental: 2
Participants in Phase 2 will receive the adaptive treatment model.
Behavioral: Adaptive treatment model
The adaptive treatment model will include up to ten 60- to 75-minute planning sessions. The sessions will focus on psychosocial issues and will be tailored to participants' specific risk factors.

Detailed Description:

Caring for a person with dementia can be a highly stressful experience associated with a variety of negative outcomes. Family caregivers are more likely than noncaregivers to experience symptoms of depression and anxiety, feelings of anger, and health problems. Although there are multiple treatment models to address the adverse mental and physical health outcomes associated with caregiving, most do not account for the specific risk and protective factor differences among caregivers of people with dementia. Such models provide the same treatment to all participants and have demonstrated only limited success in this high-risk caregiver population. An adaptive treatment model based on the Stress Process Model of caregiving, which emphasizes that there are multiple factors that affect stress, social support, and mental health, may better meet the needs of family caregivers. This study will first develop an adaptive treatment model, based on the Stress Process Model, for family caregivers of a person suffering from dementia. The study will then evaluate the effectiveness of each component of the adaptive treatment model in improving negative outcomes in the family caregivers.

This study will be conducted in two phases. Phase 1 will be used to develop an adaptive treatment model and risk report from which tailored treatment will be prescribed to participants in Phase 2. Participants in Phase 1 will attend four 90-minute interviews over 4 months. The first three interviews will be held in the first 3 to 4 weeks of the study and the last will be about 3 months later. In the first interview, participants will be asked about their experiences caring for their relatives, physical and emotional well-being, and ideas on helpful types of assistance. In the second and third interviews, participants will discuss their caregiving situations in more detail and will receive information about programs and services that may help them carry out caregiving activities. During the final interview, participants will again be asked about their experiences caring for their relatives.

Phase 2 of the study will test the adaptive treatment model developed in Phase 1. Participants in Phase 2 will attend an initial and final interview and up to 10 planning sessions. Each interview or planning session will last 60 to 75 minutes and will be tailored to the risks of each individual caregiver. During planning sessions, participants will discuss their caregiving situations in more detail, learn strategies to deal with stress, and receive information about programs and services that may help in carrying out caregiving activities. The strategies that participants will learn may include the following: new skills for communicating with the person receiving care, reflecting upon ways to reduce the impact of the changes that caregiving has had on their lives, learning more effective ways of communicating their own needs to other family members and friends, and identifying which types of services might be useful in caring for the person with dementia. The Phase 2 interviews will be the same as the initial and final interviews of Phase 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary caregiver of a person suffering from any type of dementia and living in the community

Exclusion Criteria:

  • Primary caregiver of person with late- or end-of-life stage dementia
  • Primary caregiver of person with dementia who lives in skilled nursing care environment
  • Primary caregiver is under the age of 18
  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: NCT00632684

Locations
United States, Ohio
Benjamin Rose Institute
Cleveland, Ohio, United States, 44120
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Steven H. Zarit, PhD Penn State University
Principal Investigator: Carol J. Whitlatch, PhD Benjamin Rose Institute
  More Information

No publications provided

Responsible Party: Steven H. Zarit, Penn State University
ClinicalTrials.gov Identifier: NCT00632684     History of Changes
Other Study ID Numbers: R34 MH073559, R34MH073559, DATR A4-GPS
Study First Received: March 7, 2008
Last Updated: November 22, 2011
Health Authority: United States: Federal Government

Keywords provided by Penn State University:
Family Caregiving
Dementia

ClinicalTrials.gov processed this record on November 24, 2014