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Sponsored by: |
The Jacob and Valeria Langeloth Foundation |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00409279 |
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 |
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Alzheimer Disease |
Behavioral: Information, counseling and support |
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 |
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 |
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1: Experimental
multi-component psychosocial intervention
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Behavioral: Information, counseling and support
individual-family consultation, support group, and ad hoc consultation
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2: No Intervention |
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.
Ages Eligible for Study: | 21 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Olanta Barton | 212-263-5710 | olanta.barton@med.nyu.edu |
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 |
Principal Investigator: | Mary S. Mittelman, DrPH | NYU School of Medicine |
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 |
Aging Parent / Adult-child interaction Family caregivers Alzheimer's Caregiving |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |