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

November 22, 2011 updated by: Penn State University

Adaptive Intervention for At-risk Family Caregivers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44120
        • Benjamin Rose Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Role overload
Time Frame: Measured immediately after treatment
Measured immediately after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Nine-Item Depression Scale of the Patient Health Questionnaire (PHQ-9)
Time Frame: Measured immediately after treatment
Measured immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Steven H. Zarit, PhD, Penn State University
  • Principal Investigator: Carol J. Whitlatch, PhD, Benjamin Rose Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 11, 2008

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R34MH073559 (U.S. NIH Grant/Contract)
  • DATR A4-GPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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