Comprehensive Support for Alzheimer's Disease Caregivers

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362284
• Other study ID #: H13355B
• Secondary ID: R01AG022066
• Status: Completed
• Phase: N/A
• Start date: September 2005
• Est. completion date: January 2012

Study information

• Verified date: February 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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: 1. 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; 2. 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; 3. 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 4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregivers
• Depression
• Stress

Intervention

Behavioral:
• NYUCI-AC
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

Locations

Country	Name	City	State
United States	University of Minnesota, School of Nursing, 6-150 Weaver-Densford Hall	Minneapolis	Minnesota
United States	Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Albers, Elizabeth, A. (2020). A Longitudinal Analysis of the Effects of the NYU Caregiver Intervention-Adult Child on Subjective Health. Retrieved from the University of Minnesota Digital Conservancy, http://hdl.handle.net/11299/217050.

Gaugler JE, Reese M, Mittelman MS. Effects of the Minnesota Adaptation of the NYU Caregiver Intervention on Depressive Symptoms and Quality of Life for Adult Child Caregivers of Persons with Dementia. Am J Geriatr Psychiatry. 2015 Nov;23(11):1179-92. doi: — View Citation

Gaugler JE, Reese M, Mittelman MS. Effects of the Minnesota Adaptation of the NYU Caregiver Intervention on Primary Subjective Stress of Adult Child Caregivers of Persons With Dementia. Gerontologist. 2016 Jun;56(3):461-74. doi: 10.1093/geront/gnu125. Epu — View Citation

Gaugler JE, Reese M, Mittelman MS. Effects of the NYU caregiver intervention-adult child on residential care placement. Gerontologist. 2013 Dec;53(6):985-97. doi: 10.1093/geront/gns193. Epub 2013 Jan 20. — View Citation

Gaugler JE, Reese M, Mittelman MS. Process Evaluation of the NYU Caregiver Intervention-Adult Child. Gerontologist. 2018 Mar 19;58(2):e107-e117. doi: 10.1093/geront/gnx048. — View Citation

Gaugler JE, Reese M, Mittelman MS. The Effects of a Comprehensive Psychosocial Intervention on Secondary Stressors and Social Support for Adult Child Caregivers of Persons With Dementia. Innov Aging. 2018 Jun;2(2):igy015. doi: 10.1093/geroni/igy015. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	caregiver depression	The Geriatric Depression Scale.	baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
Primary	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	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	secondary stressors	Measures of family and role conflict.	baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible