The Black Immigrant Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Caregiving: Enhancing Skills.
- Who it may be relevant to
- Registry conditions: Dementia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploring an Adapted Active Caregiving: Empowering Skills (ACES) Intervention for High-Risk Care Partners
Overview
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.
Interventions
- Other 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
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT07546708 · ACES · CON000000106758 · CON000000094116