NCT00362284

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

6.3 years

First QC Date

August 8, 2006

Last Update Submit

February 9, 2022

Conditions

CaregiversStressDepression

Keywords

Alzheimer's diseasecopingquality of lifecaregiving

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • caregiver depression

    The Geriatric Depression Scale.

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

  • 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 Outcomes (2)

  • Caregiver subjective health

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

  • secondary stressors

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

Study Arms (2)

NYUCI-AC group

EXPERIMENTAL

Adult children in this arm received the NYUCI-AC intervention, which consisted of 6 individual and family counseling sessions, the offering of an adult child specific support group, and the provision of ad hoc, or ongoing, consultation throughout the duration of participation.

Behavioral: NYUCI-AC

Usual care control

NO INTERVENTION

Adult children randomly assigned to the usual care control did not receive the NYUCI-AC intervention. If they were in crisis or required support, the NYUCI-AC counselors provided information and referral on an as-needed basis.

Interventions

NYUCI-ACBEHAVIORAL

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

NYUCI-AC group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Minneapolis, Minnesota, 55455, United States

Location

Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine

New York, New York, 10016, United States

Location

Related Publications (6)

  • 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.

    PMID: 29562359BACKGROUND

  • 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.

    PMID: 23339050RESULT

  • 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. Epub 2015 Jan 27.

    PMID: 25628299RESULT

  • 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: 10.1016/j.jagp.2015.06.007. Epub 2015 Jun 25.

    PMID: 26238226RESULT

  • 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 2018 Jun 22.

    PMID: 30009268RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

DepressionAlzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Joseph E. Gaugler, PhD

    University of Minnesota, Center on Aging, Center for Gerontological Nursing, School of Nursing

    PRINCIPAL INVESTIGATOR

  • Mary Mittelman, DrPH

    Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 9, 2006

Study Start

September 1, 2005

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations

US(2)