The Black Immigrant Project

April 16, 2026 updated by: University of Minnesota

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.

Study Overview

Status

Recruiting

Conditions

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

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Manka Nkimbeng, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

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

No

Studies a U.S. FDA-regulated device product

No

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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