- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546708
The Black Immigrant Project
Exploring an Adapted Active Caregiving: Empowering Skills (ACES) Intervention for High-Risk Care Partners
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed study has two major aims. First, the goal is to determine the feasibility of implementing the adapted ACES intervention with Black immigrant families. It uses an explanatory mixed-methods study, including quantitative data collected using a pre-posttest design, and in-depth qualitative interviews with participants following the post-test to understand their experiences with the newly adapted intervention.
Secondly, an extended version of the study will test the potential mechanisms of action in the adapted ACES intervention with Black immigrant caregivers. Specifically, it will examine whether cognitive appraisal and behavioral activation are mechanisms of action that influence the effects of the adapted intervention on care partner outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manka Nkimbeng, PhD
- Phone Number: 612-624-3904
- Email: vitals@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Manka Nkimbeng, PhD
- Phone Number: 612-624-3904
- Email: vitals@umn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Person with dementia:
Inclusion Criteria:
- Family or self-identified report of dementia/memory loss,
- Score <3 on the Six-item Screener.
- Age 50 or older.
- Ability to communicate in English.
- Identify as a Black immigrant.
- Ability to give verbal assent.
Exclusion Criteria
- Under age 50.
- Not a Black immigrant.
- Cannot communicate in English.
- Unable to give verbal assent.
Caregiver:
Inclusion criteria:
- Black immigrant care partner of persons with AD/ADRD.
- Age 18 or older.
- Ability to communicate in English.
- Identify as a first/second-generation Black immigrant.
- Have had at least 6 months of caregiving (any help or assistance provided to a relative related to dementia/memory loss).
Exclusion Criteria
- Under age 18.
- Not first/second generation Black immigrant.
- Cannot communicate in English.
- Has less than 6 months of caregiving to a relative with dementia/memory loss.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Adapted ACES intervention
The adapted Active Caregiving: Enhancing Skills intervention was developed in partnership with Black immigrant dementia care partners.
It is based on Cognitive Behavioral Therapy (a type of psychotherapy) and suggests that a person's behavior and affect are guided by how they structure the world.
Through the process of cognitive appraisal (how to evaluate something in your mind) and behavioral activation (how to start a new behavior), the intervention will help the caregiver change their cognitive appraisal (e.g., re-orienting the way they think) and behavioral skills (e.g., changing their behavior or activities) to cope with difficulties in the caregiving process.
This group program has six modules that will be offered over weekly sessions through remote technology such as Zoom.
|
The Active Caregiving: Enhancing Skills intervention was developed in partnership with Black immigrant dementia care partners.
It is based on Cognitive Behavioral Therapy (one type of psychotherapy), and it suggests that a person's behavior and affect are guided by how they structure the world.
Through the process of cognitive appraisal (how to evaluate something in your mind) and behavioral activation (how to start a new behavior), the intervention will help the caregiver change their cognitive appraisal (e.g., re-orienting the way they think) and behavioral skills (e.g., changing their behavior or activities) to cope with difficulties in the caregiving process.
This group program has six modules that will be offered over weekly sessions through remote technology such as Zoom.
|
|
No Intervention: Waitlist control group
Participants in this arm will receive the adapted ACES intervention following the waiting period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression: Week 6
Time Frame: Week 6
|
Scale Reference: Kroenke et al. 2009 Min=0-Low Max=24-High
|
Week 6
|
|
Depression: Month 4.5
Time Frame: Month 4.5
|
Scale Reference: Kroenke et al. 2009 Min=0-Low Max=24-High
|
Month 4.5
|
|
Caregiver Burden: Month 3
Time Frame: Month 3
|
Burden Scale for Family Caregivers (BSFCs): Min=0-- Bad Max=30--Good |
Month 3
|
|
Caregiver Burden: Month 4.5
Time Frame: Month 4.5
|
Burden Scale for Family Caregivers (BSFCs): Min=0-- Bad Max=30--Good |
Month 4.5
|
|
Quality of Life: Month 3
Time Frame: Month 3
|
Global Health Scale (PROMIS) Min=8--Worst Max=50--Best
|
Month 3
|
|
Quality of Life: Month 4.5
Time Frame: Month 4.5
|
Global Health Scale (PROMIS) Min=8--Worst Max=50--Best
|
Month 4.5
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manka Nkimbeng, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACES
- CON000000106758 (Other Grant/Funding Number: NIH NATIONAL INSTITUTE ON AGING)
- CON000000094116 (Other Grant/Funding Number: NIH NATIONAL INSTITUTE ON AGING)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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