Comprehensive Support for Alzheimer's Disease Caregivers

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of a comprehensive counseling and support intervention for people who care for parents with Alzheimer's disease (AD) or other dementias on outcomes such as stress, depression and ability to postpone or avoid nursing home placement.

Detailed Description
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Although a range of studies have examined the stress and depression of family caregivers of persons suffering from dementia, the effectiveness of psychosocial interventions to assist caregiving families and their disabled elderly relatives is uncertain. The comprehensive support protocol to be implemented, the Enhanced Counseling and Support (ECS) program, has been successfully implemented at the Silberstein Aging and Dementia Research Center of New York University School of Medicine (NYU-ADRC) over the past 19 years. However, the initial evaluation of the ECS was limited to a single geographic area (New York City proper) and a specific type of dementia caregiver (spouses). The specific aims of this 4-year project are as follows: 1) Examine whether the ECS can achieve positive outcomes for adult child caregivers. Few psychosocial interventions are directed specifically at adult child caregivers, and evaluating the ECS in adult child caregiving situations, which few studies have done, will further demonstrate the effectiveness of this program and add considerably to the AD caregiver intervention literature; and 2) Determine if the ECS, an intervention of proven efficacy for AD caregivers in a northern U.S. urban community (New York City), will also be effective in alleviating negative outcomes among AD caregivers at a Midwestern project site. The study will ascertain whether the comprehensive support program developed at NYU is generalizable to caregivers from areas other than the New York City area and leads to similar benefits that are maintained over long periods of time (i.e., up to 3.5 years). In order to accomplish the specific aims of the project, the following study hypotheses have been proposed: Adult child caregivers in the treatment conditions of the University of Minnesota (UM) and NYU-ADRC will report similar decreases on measures of stress when compared to usual-contact controls; Adult child caregivers in the intervention conditions at both sites will develop improved social support resources and experience significantly greater decreases of family conflict in a similar manner; Adult child caregivers in the treatment conditions at UM and NYU-ADRC will report similar decreases on global measures of psychological distress, such as depression. Similarly, treatment caregivers will report greater increases in subjective health than their counterparts in the usual-contact control; and Membership in the treatment condition of the ECS and its benefits (e.g., increased social support, decreased stress) will lead to delayed institutionalization (e.g., nursing home placement) of care recipients at the UM and NYU-ADC sites.

Official Title
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Expanded Counseling and Support for Adult Children Caring for Parents With Alzheimer's Disease or Similar Disorders

Conditions
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Caregivers, Stress, Depression

Intervention / Treatment
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* Behavioral: NYUCI-AC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant (i.e., adult child) must be the 'primary' caregiver of the patient with a diagnosis of dementia (i.e., the first person called if the patient is in need of help) at the time of the baseline interview Must be a daughter, son, daughter-in-law, or son-in-law of the patient Patient must live in the community (i.e., at home, with the caregiver, with other relatives) Sees the individual with dementia once a week or more Exclusion Criteria: Unable to understand or speak English comfortably Inadequate hearing Unwilling to participate in the study or sign the consent form Suffered from or received treatment for an emotional or psychological disorder, such as depression, anxiety, or some other type of psychotic episode, within the past 6 months Not physically able to participate Received counseling for problems arising as a caregiver

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NYUCI-AC group<br>Adult children in this arm received the NYUCI-AC intervention, which consisted of 6 individual and family counseling sessions, the offering of an adult child specific support group, and the provision of ad hoc, or ongoing, consultation throughout the duration of participation. | Behavioral: NYUCI-AC<br>* Approximately six individual and family consultation sessions (2 individual, 3 family, 1 individual) within the first 4 months with adult child caregivers and/or their family members; support group participation (recommended at least once a month) after the completion of the individual and family consultation sessions for the duration of the project (up to 3 years after the intake interview); ad hoc consultation (ongoing in-person, telephone, or email support on an as-needed basis) for the duration of the project (up to 3 years after the intake interview); New York University Caregiver Intervention<br>|
| No Intervention: Usual care control<br>Adult children randomly assigned to the usual care control did not receive the NYUCI-AC intervention. If they were in crisis or required support, the NYUCI-AC counselors provided information and referral on an as-needed basis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Care recipient nursing home/institutional placement | Adult child caregivers self-reported whether the care recipient was admitted to a residential care setting and the date of admission. | baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible | 
| Caregiver emotional stress | Measures of role captivity, role overload, and general perceived stress. | baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible | 
| caregiver depression | The Geriatric Depression Scale. | baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible | 
| caregiver social support | Three single items that measured perceptions of support received by the adult child caregiver. | baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver subjective health | Single item self-reported health as well as measures derived from the OARS. | baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible | 
| secondary stressors | Measures of family and role conflict. | baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, coping, quality of life, caregiving