An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00409279
• Other study ID #: IA0097
• Secondary ID: Project #195
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2006
• Last updated: February 28, 2008
• Start date: September 2003
• Est. completion date: April 2008

Study information

• Verified date: February 2008
• Source: National Institute on Aging (NIA)
• Contact: Olanta Barton
• Phone: 212-263-5710
• Email: olanta.barton[@]med.nyu.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Men or women between the ages of 21 and 90

• Adult-child caring for at least one parent who has been diagnosed with Alzheimer's disease and is in the moderate stage

• Person with Alzheimer's disease must be living at home or in a congregate residential setting that is like a home

• Caregiver must be willing to complete intake and follow-up questionnaires

• Caregiver must be willing to attend 2 workshops and 1 individual counseling session

Exclusion Criteria:

• Severe psychological or physical illness

• Unwillingness to participate in all aspects of the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• Information, counseling and support
individual-family consultation, support group, and ad hoc consultation

Locations

Country	Name	City	State
United States	Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Jacob and Valeria Langeloth Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Mittelman MS, Ferris SH, Shulman E, Steinberg G, Ambinder A, Mackell JA, Cohen J. A comprehensive support program: effect on depression in spouse-caregivers of AD patients. Gerontologist. 1995 Dec;35(6):792-802. — View Citation

Mittelman MS, Ferris SH, Shulman E, Steinberg G, Levin B. A family intervention to delay nursing home placement of patients with Alzheimer disease. A randomized controlled trial. JAMA. 1996 Dec 4;276(21):1725-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in measures of depression, stress, and anxiety		six and nine months from baseline	No