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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00409279
Recruitment Status : Unknown
Verified February 2008 by National Institute on Aging (NIA).
Recruitment status was:  Recruiting
First Posted : December 8, 2006
Last Update Posted : March 3, 2008
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Information, counseling and support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease
Study Start Date : September 2003
Estimated Primary Completion Date : April 2008
Estimated Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: 1
multi-component psychosocial intervention
Behavioral: Information, counseling and support
individual-family consultation, support group, and ad hoc consultation

No Intervention: 2

Primary Outcome Measures :
  1. Changes in measures of depression, stress, and anxiety [ Time Frame: six and nine months from baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00409279

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Contact: Olanta Barton 212-263-5710

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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   
Sponsors and Collaborators
The Jacob and Valeria Langeloth Foundation
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Principal Investigator: Mary S. Mittelman, DrPH NYU School of Medicine

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Responsible Party: Joseph E. Gaugler, Ph.D., Assistant Professor, University of Minnesota, School of Nursing Identifier: NCT00409279     History of Changes
Other Study ID Numbers: IA0097
Project #195
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: March 3, 2008
Last Verified: February 2008

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

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders