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NCT Number: NCT07546708

The Black Immigrant Project

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Manka Nkimbeng, PhD

CONTACT

[email protected]

612-624-3904

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Caregiving: Enhancing Skills

Other

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 outcomes

  1. Depression: Week 6

    Time frame: Week 6

    Scale Reference: Kroenke et al. 2009 Min=0-Low Max=24-High

  2. Depression: Month 4.5

    Time frame: Month 4.5

    Scale Reference: Kroenke et al. 2009 Min=0-Low Max=24-High

  3. Caregiver Burden: Month 3

    Time frame: Month 3

    Burden Scale for Family Caregivers (BSFCs):

    Min=0-- Bad Max=30--Good

  4. Caregiver Burden: Month 4.5

    Time frame: Month 4.5

    Burden Scale for Family Caregivers (BSFCs):

    Min=0-- Bad Max=30--Good

  5. Quality of Life: Month 3

    Time frame: Month 3

    Global Health Scale (PROMIS) Min=8--Worst Max=50--Best

  6. Quality of Life: Month 4.5

    Time frame: Month 4.5

    Global Health Scale (PROMIS) Min=8--Worst Max=50--Best

Study contacts

Contact information is provided by the study sponsor or research team.

Manka Nkimbeng, PhD

CONTACT

[email protected]

612-624-3904

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Exploring an Adapted Active Caregiving: Empowering Skills (ACES) Intervention for High-Risk Care Partners

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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