DementiaNCT07546708
The Black Immigrant Project
A study testing Active Caregiving: Enhancing Skills in people with Dementia, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Active Caregiving: Enhancing Skills
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- Under age 50.
- Not a Black immigrant.
- Cannot communicate in English.
- Unable to give verbal assent.
- Caregiver:
- Under age 18.
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- Not first/second generation Black immigrant.
- Cannot communicate in English.
- Has less than 6 months of caregiving to a relative with dementia/memory loss.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Manka Nkimbeng, PhD, 612-624-3904, vitals@umn.edu
About this study
Official title: Exploring an Adapted Active Caregiving: Empowering Skills (ACES) Intervention for High-Risk Care Partners
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Active Caregiving: Enhancing Skills
- Keywords
- Black immigrants
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Caregiving: Enhancing SkillsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adapted ACES intervention | Active comparator | 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. Receives: Other: Active Caregiving: Enhancing Skills |
| Waitlist control group | No intervention | Participants in this arm will receive the adapted ACES intervention following the waiting period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression: Week 6
Scale Reference: Kroenke et al. 2009 Min=0-Low Max=24-High
Measured: Week 6
Depression: Month 4.5
Scale Reference: Kroenke et al. 2009 Min=0-Low Max=24-High
Measured: Month 4.5
Caregiver Burden: Month 3
Burden Scale for Family Caregivers (BSFCs):
Min=0-- Bad Max=30--Good
Measured: Month 3
Caregiver Burden: Month 4.5
Burden Scale for Family Caregivers (BSFCs):
Min=0-- Bad Max=30--Good
Measured: Month 4.5
Quality of Life: Month 3
Global Health Scale (PROMIS) Min=8--Worst Max=50--Best
Measured: Month 3
Quality of Life: Month 4.5
Global Health Scale (PROMIS) Min=8--Worst Max=50--Best
Measured: Month 4.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Mar 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manka Nkimbeng, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546708
- Sponsor's protocol ID
- ACES
- Other IDs
- CON000000106758, CON000000094116
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring an Adapted Active Caregiving: Empowering Skills (ACES) Intervention for High-Risk Care Partners
- ClinicalTrials.gov ID
- NCT07546708
- Acronym / sponsor ID
- ACES
- Conditions
- Dementia
- Keywords
- Black immigrants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted ACES intervention | Active comparator | Other: Active Caregiving: Enhancing SkillsThe 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. |
| Waitlist control group | No intervention | –Participants in this arm will receive the adapted ACES intervention following the waiting period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- Under age 50.
- Not a Black immigrant.
- Cannot communicate in English.
- Unable to give verbal assent.
- Under age 18.
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 |
|---|---|---|
| Active Caregiving: Enhancing SkillsThe 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. | Other | Adapted ACES intervention |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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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.
Manka Nkimbeng, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Caregiving: Enhancing Skills in people with Dementia, run by University of Minnesota 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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manka Nkimbeng, PhD (612-624-3904, vitals@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression: Week 6 (time frame: Week 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.