Skip to main content
OpenTrials
Completed

NCT Number: NCT00362284

Comprehensive Support for Alzheimer's Disease Caregivers

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, School of Nursing, 6-150 Weaver-Densford Hall, Minneapolis, Minnesota, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NYUCI-AC

Behavioral

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

Primary outcomes

  1. Care recipient nursing home/institutional placement

    Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

    Adult child caregivers self-reported whether the care recipient was admitted to a residential care setting and the date of admission.

  2. Caregiver emotional stress

    Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

    Measures of role captivity, role overload, and general perceived stress.

  3. caregiver depression

    Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

    The Geriatric Depression Scale.

  4. caregiver social support

    Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

    Three single items that measured perceptions of support received by the adult child caregiver.

Secondary outcomes

  1. Caregiver subjective health

    Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

    Single item self-reported health as well as measures derived from the OARS.

  2. secondary stressors

    Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

    Measures of family and role conflict.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2012
First posted
Aug 9, 2006
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.