An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Behavioral: Information, counseling and support||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
U.S. FDA Resources
multi-component psychosocial intervention
Behavioral: Information, counseling and support
individual-family consultation, support group, and ad hoc consultation
|No Intervention: 2|
- Changes in measures of depression, stress, and anxiety [ Time Frame: six and nine months from baseline ]
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 ClinicalTrials.gov identifier (NCT number): NCT00409279
|Contact: Olanta Bartonfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Mary S. Mittelman, DrPH||NYU School of Medicine|