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An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease
This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), February 2008
First Received: December 7, 2006   Last Updated: February 28, 2008   History of Changes
Sponsored by: The Jacob and Valeria Langeloth Foundation
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00409279
  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

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Anxiety Caregivers Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title: An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease

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
1: Experimental
multi-component psychosocial intervention
Behavioral: Information, counseling and support
individual-family consultation, support group, and ad hoc consultation
2: No Intervention

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

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

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

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

ClinicalTrials.gov processed this record on May 07, 2009