Alzheimer DiseaseNCT00409279
An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease
A study testing Information, counseling and support in people with Alzheimer Disease, run by The Jacob and Valeria Langeloth Foundation at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Information, counseling and support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe psychological or physical illness
- Unwillingness to participate in all aspects of the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine
New York, New York, 10016
Olanta Barton, 212-263-5710, olanta.barton@med.nyu.edu
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- Information, counseling and support
- Keywords
- Aging, Parent / Adult-child interaction, Family caregivers, Alzheimer's, Caregiving
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information, counseling and supportBehavioural
individual-family consultation, support group, and ad hoc consultation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | multi-component psychosocial intervention Receives: Behavioral: Information, counseling and support |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in measures of depression, stress, and anxiety
Measured: six and nine months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startSep 2003
- Primary completionApr 2008 (estimated)
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Jacob and Valeria Langeloth Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Mary S. Mittelman, DrPH, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409279
- Sponsor's protocol ID
- IA0097
- Other IDs
- Project #195
- Status last verified
- Feb 2008
- First submitted
- 7 Dec 2006
- Last updated
- 3 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
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 8557206Mittelman 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00409279
- Acronym / sponsor ID
- IA0097
- Conditions
- Alzheimer Disease
- Keywords
- Aging, Parent / Adult-child interaction, Family caregivers, Alzheimer's, Caregiving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Jacob and Valeria Langeloth FoundationUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Apr 2008 (estimated)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Information, counseling and supportmulti-component psychosocial intervention |
| 2 | No intervention | – |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Severe psychological or physical illness
- Unwillingness to participate in all aspects of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information, counseling and supportindividual-family consultation, support group, and ad hoc consultation | Behavioural | 1 |
Primary outcome
Changes in measures of depression, stress, and anxiety
Time frame: six and nine months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2008.
- Background: PubMed 8557206Mittelman 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.
- Background: PubMed 8940320Mittelman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary S. Mittelman, DrPH principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information, counseling and support in people with Alzheimer Disease, run by The Jacob and Valeria Langeloth Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olanta Barton (212-263-5710, olanta.barton@med.nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in measures of depression, stress, and anxiety (time frame: six and nine months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00409279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2008.