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Cultural Adaptation of a Behavioral Intervention for Latino Caregivers

Cultural Adaptation of a Behavioral Intervention for Latino Caregivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04633408
Enrollment
21
Registered
2020-11-18
Start date
2020-07-01
Completion date
2024-06-30
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Dementia

Keywords

Latino, Caregiver, Cultural adaptation

Brief summary

The overall objectives of the proposed research are to: (i) develop a prototype of a smartphone application (app) that can deliver culturally adapted STAR-C training to Latino caregivers, and (ii) understand the extent to which a STAR-C app is acceptable and potentially effective among Latino caregivers. Achieving these objectives will lay the groundwork for a future full-scale trial to test the STAR-C app with Latino caregivers. This study aims to: Adapt the STAR-C training to increase cultural relevance for Latino caregivers. The adaptations will focus on incorporating cultural examples, identities, values, beliefs, and practices within the training, as well as using cultural idioms, metaphors, and sayings to compliment explanations. Develop a prototype of a STAR-C app for Latino caregivers. The prototype will be iteratively developed with active participation from Latino caregivers. The final prototype will consist of a fully interactive app that delivers culturally relevant STAR-C training in an engaging and easy to use format. Assess the acceptability and potential effectiveness of the STAR-C app for Latino caregivers. Measures of acceptability will include app usage and perceived ease-of-use and usefulness of the STAR-C app. Measures of potential effectiveness will include changes in caregiver burden and depression.

Detailed description

For aim 1, the investigators plan to recruit 25-30 participants with representation from both caregivers and providers. The investigators will recruit Latino Family Caregivers of persons with ADRD (Alzheimer's Disease and related Dementias). The investigators will recruit providers who work in an organization serving Latino elderly. Participants will be \>18 years old. For aim 2, the investigators will recruit 5 caregivers per session. With three iterative design sessions, the investigators anticipate 15 caregivers in total. The investigators will use the same eligibility criteria described for aim 1. For aim 3, the investigators will recruit 15 Latino caregivers for each study arm (total sample size of 30). The investigators based the sample size on a rule of thumb of 12 to 15 participants per group for pilot studies. The investigators will use the same eligibility criteria and recruitment strategy described for aim 1

Interventions

BEHAVIORALSTAR-C Virtual Training and Follow-up (STAR-VTF)

STAR-C Virtual Training and Follow-up (STAR-VTF) is adapted from an evidence-based, in-person program that trains family caregivers to manage BPSD (behavioral and psychological symptoms of dementia)

Sponsors

Alzheimer's Association
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

A qualitative study, a participatory design study and a randomized pilot study to assess acceptability of an intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Aged 18 years or older * Family member or close friend of a person with ADRD * Provide at least eight hours of care per week Speak English or Spanish * Self-identify as Latino.

Exclusion criteria

* Caregiver who has a diagnosis of ADRD

Design outcomes

Primary

MeasureTime frameDescription
Acceptability2 monthsTo assess acceptability, the investigators will measure: (1) app usage. The investigators will obtain data automatically collected by the platform to measure whether caregivers complete the training sessions, how many times caregivers visited the app, and the amount of time between app visits.
Potential Effectiveness2 monthsTo assess potential effectiveness, the investigators will measure (1) caregiver burden. For caregiver burden, the investigators will administer the Screen for Caregiver Burden (SCB). The 25-item SCB, provides scores for objective burden (OB; number of potentially negative experiences) and subjective burden (SB; appraised distress in response to the experiences). OB scores caregiver experiences that have occurred, regardless of their distress; it scores each item as 0 (did not occur) or 1 (indicating occurrence). SB scores evaluate the distress associated with the experiences; it uses five anchor points: 0 = no occurrence of the experience: 1 = occurrence of the experience, but no distress; 2 = occurrence with mild distress; 3 = occurrence with moderate distress; and 4 = occurrence with severe distress.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026