NCT00409279

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 3, 2008

Status Verified

February 1, 2008

Enrollment Period

4.6 years

First QC Date

December 7, 2006

Last Update Submit

February 28, 2008

Conditions

Alzheimer Disease

Keywords

AgingParent / Adult-child interactionFamily caregiversAlzheimer'sCaregiving

Outcome Measures

Primary Outcomes (1)

  • Changes in measures of depression, stress, and anxiety

    six and nine months from baseline

Study Arms (2)

1

EXPERIMENTAL

multi-component psychosocial intervention

Behavioral: Information, counseling and support

2

NO INTERVENTION

Interventions

Information, counseling and supportBEHAVIORAL

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

1

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine

New York, New York, 10016, United States

RECRUITING

Related 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. doi: 10.1093/geront/35.6.792.

    PMID: 8557206BACKGROUND

  • 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.

    PMID: 8940320BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

CounselingPalliative Care

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPatient CareTherapeutics

Study Officials

  • Mary S. Mittelman, DrPH

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olanta Barton

CONTACT

212-263-5710olanta.barton@med.nyu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

September 1, 2003

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

March 3, 2008

Record last verified: 2008-02

Locations

US(1)