CClinicalTrials.gg
Status unknownNCT00409279Updated Mar 3, 2008

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

An interventional study of Information, counseling and support in Alzheimer Disease, sponsored by The Jacob and Valeria Langeloth Foundation. Status unknown at 1 site in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2008-03-03.

Sponsored by The Jacob and Valeria Langeloth Foundation · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Feb 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years to 90 Years
Sex
All
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Study 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).

Read the detailed 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.

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Conditions studied

  • Alzheimer Disease

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Keywords

  • Aging
  • Parent / Adult-child interaction
  • Family caregivers
  • Alzheimer's
  • Caregiving
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

This is the only study on the registry with The Jacob and Valeria Langeloth Foundation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Severe psychological or physical illness
  • Unwillingness to participate in all aspects of the study
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    1

    multi-component psychosocial intervention

    Behavioral: Information, counseling and support

  • No intervention
    2

Interventions

  • BehavioralInformation, counseling and support

    individual-family consultation, support group, and ad hoc consultation

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What researchers measure

Primary outcomes

  1. Changes in measures of depression, stress, and anxiety

    Time frame: six and nine months from baseline

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Study locations

1 of 1 sites recruiting
  • Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine
    New York, New York 10016, United States
    Recruiting
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References and documents

Publications

  • 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. doi: 10.1093/geront/35.6.792. PubMed 8557206 ↗
  • 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. PubMed 8940320 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00409279
Lead sponsor
The Jacob and Valeria Langeloth Foundation
First posted
Dec 8, 2006
Start date
Sep 2003
Primary completion
Apr 2008 (estimated)
Completion
Apr 2008 (estimated)
Last update
Mar 3, 2008

Study contacts

Olanta Barton
Contact
olanta.barton@med.nyu.edu
212-263-5710
Mary S. Mittelman, DrPH
principal investigator · NYU School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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