Recruiting

ACES Intervention

Sponsor:

University of Minnesota

Code:

NCT07546708

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active Caregiving: Enhancing Skills

Study Details

Brief 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.

Conditions

Dementia

Study ID

NCT07546708

Start date

Mar 1, 2026

Status verified date

Apr, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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\&#39;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.

Interventions

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 measure

  • Depression: Week 6 [ Time Frame: Week 6 ]
  • Depression: Month 4.5 [ Time Frame: Month 4.5 ]
  • Caregiver Burden: Month 3 [ Time Frame: Month 3 ]
  • Caregiver Burden: Month 4.5 [ Time Frame: Month 4.5 ]
  • Quality of Life: Month 3 [ Time Frame: Month 3 ]
  • Quality of Life: Month 4.5 [ Time Frame: Month 4.5 ]

Central Contacts and Locations

Central contacts

Manka Nkimbeng, PhD

612-624-3904vitals@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Manka Nkimbeng, PhD

612-624-3904vitals@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Black immigrants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-04-23.