NCT07546708

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Apr 2028

Study Start

First participant enrolled

March 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

March 3, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

Black immigrants

Outcome Measures

Primary Outcomes (6)

  • Depression: Week 6

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

    Week 6

  • Depression: Month 4.5

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

    Month 4.5

  • Caregiver Burden: Month 3

    Burden Scale for Family Caregivers (BSFCs): Min=0-- Bad Max=30--Good

    Month 3

  • Caregiver Burden: Month 4.5

    Burden Scale for Family Caregivers (BSFCs): Min=0-- Bad Max=30--Good

    Month 4.5

  • Quality of Life: Month 3

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

    Month 3

  • Quality of Life: Month 4.5

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

    Month 4.5

Study Arms (2)

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.

Other: Active Caregiving: Enhancing Skills

Waitlist control group

NO INTERVENTION

Participants in this arm will receive the adapted ACES intervention following the waiting period.

Interventions

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.

Adapted ACES intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Under age 50.
  • Not a Black immigrant.
  • Cannot communicate in English.
  • Unable to give verbal assent.
  • Caregiver:
  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Manka Nkimbeng, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manka Nkimbeng, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

April 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations