An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00409279
First received: December 7, 2006
Last updated: February 28, 2008
Last verified: February 2008
  Purpose

The goal of this project is to test an intervention designed to reduce the incidence and magnitude of the negative effects, specifically stress, anxiety, and depression, frequently experienced by adult children who are caregivers of a parent with Alzheimer's disease (AD).


Condition Intervention
Alzheimer Disease
Behavioral: Information, counseling and support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Changes in measures of depression, stress, and anxiety [ Time Frame: six and nine months from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2003
Estimated Study Completion Date: April 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
multi-component psychosocial intervention
Behavioral: Information, counseling and support
individual-family consultation, support group, and ad hoc consultation
No Intervention: 2

Detailed Description:

Caring for an elderly parent is a growing societal problem, and many studies have shown that caring for a person with dementia can have a negative impact on a caregiver's psychological and physical health, social life and career, and relationship with the patient. Stress and coping models proposed in the AD caregiving literature, and general stress and coping theories suggest that by improving caregivers' ability to cope and master the caregiving situation, it is possible to avoid or ameliorate the negative emotional consequences of caregiving.

Building upon the results of a pilot study, this study will formally test the efficacy of a psychosocial intervention, based on a concept of caregiving that builds on the interests, activities, and responsibilities of both the caregiver and patient in creating a care strategy. The intervention is designed to reduce the negative effects frequently experienced by adult children who care for a parent in the middle stage of Alzheimer's disease. Caregivers will learn to engage with their parents in activities that are within the patients' remaining functional and cognitive abilities. Caregivers will also be encouraged to teach activities to other family members and paid caregivers. The study will also evaluate a lower level of intervention, based on written materials.

It is expected that by increasing knowledge about AD and providing what may be a new conceptual approach to relating to a parent at this point in the disease process, 1) caregivers and patients may experience a higher level of satisfaction and gratification from their interactions, 2) caregivers will gain a sense of control and mastery over a difficult situation and thus feel more capable of coping and 3) the patient may maintain a higher level of functioning.

A randomized treatment/control design will be used, and adult-child caregivers who participate will be assigned to one of the two levels of intervention, each designed to reduce stress, anxiety and depression. The benefits of each intervention will be evaluated by looking at the change in scores on widely used measures of the anticipated outcomes among caregivers in each group, and their relative benefits will be tested by comparing scores of the caregivers in the two groups at two follow-up points, six and nine months after baseline.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women between the ages of 21 and 90
  • Adult-child caring for at least one parent who has been diagnosed with Alzheimer's disease and is in the moderate stage
  • Person with Alzheimer's disease must be living at home or in a congregate residential setting that is like a home
  • Caregiver must be willing to complete intake and follow-up questionnaires
  • Caregiver must be willing to attend 2 workshops and 1 individual counseling session

Exclusion Criteria:

  • Severe psychological or physical illness
  • Unwillingness to participate in all aspects of the study
  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: NCT00409279

Contacts
Contact: Olanta Barton 212-263-5710 olanta.barton@med.nyu.edu

Locations
United States, New York
Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Olanta Barton    212-263-5710    olanta.barton@med.nyu.edu   
Sponsors and Collaborators
The Jacob and Valeria Langeloth Foundation
Investigators
Principal Investigator: Mary S. Mittelman, DrPH NYU School of Medicine
  More Information

Publications:
Responsible Party: Joseph E. Gaugler, Ph.D., Assistant Professor, University of Minnesota, School of Nursing
ClinicalTrials.gov Identifier: NCT00409279     History of Changes
Other Study ID Numbers: IA0097, Project #195
Study First Received: December 7, 2006
Last Updated: February 28, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Aging
Parent / Adult-child interaction
Family caregivers
Alzheimer's
Caregiving

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014