NCT07546708 · University of Minnesota
The Black Immigrant Project
What this study is about
This stage I trial will examine if the culturally adapted ACES intervention affects cognitive appraisal (self-effectiveness and dysfunctional thoughts) and behavioral activation with Black immigrant living with dementia and their care partners over a 1-month and 3-month period.
View original scientific description
This stage I trial will examine if the culturally adapted ACES intervention affects cognitive appraisal (self-efficacy and dysfunctional thoughts) and behavioral activation with Black immigrant living with dementia and their care partners over a 1-month and 3-month period.
Interventions
OTHER
Active Caregiving: Enhancing Skills
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.
Primary outcome measures
Depression: Week 6
Time frame: Week 6
Scale Reference: Kroenke et al. 2009 Min=0-Low Max=24-High
Depression: Month 4.5
Time frame: Month 4.5
Scale Reference: Kroenke et al. 2009 Min=0-Low Max=24-High
Caregiver Burden: Month 3
Time frame: Month 3
Burden Scale for Family Caregivers (BSFCs): Min=0-- Bad Max=30--Good
Caregiver Burden: Month 4.5
Time frame: Month 4.5
Burden Scale for Family Caregivers (BSFCs): Min=0-- Bad Max=30--Good
Quality of Life: Month 3
Time frame: Month 3
Global Health Scale (PROMIS) Min=8--Worst Max=50--Best
Quality of Life: Month 4.5
Time frame: Month 4.5
Global Health Scale (PROMIS) Min=8--Worst Max=50--Best
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations