Cultural Adaptation of a Behavioral Intervention for Latino Caregivers

NCT04633408 | Completed

• 1 other identifier: STUDY00009534
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer Disease; Dementia

Keywords

Latino; Caregiver; Cultural adaptation

Outcome Measures

Primary Outcomes (5)

• Acceptability

  To 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.

  2 months

• Acceptability

  To assess acceptability, the investigators will measure (2) perceived ease-of-use. For perceived ease-of-use, the investigators will administer the System Usability Scale. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree (score 5) to Strongly disagree (score 1).

  2 months

• Acceptability

  To assess acceptability, the investigators will measure (3) perceived usefulness. For perceived usefulness, the investigators will administer the Perceived Usefulness Scale. It consists of a 6 item questionnaire, all items are measured on a 7-point Likert-type scale ranging from "strongly disagree" (score 1) to "strongly agree" (score 7).

  2 months

• Potential Effectiveness

  To 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.

  2 months

• Potential Effectiveness

  To assess potential effectiveness, the investigators will measure (2) caregiver depression. For caregiver depression, the investigators will use the full Patient Health Questionnaire (PHQ)-9. PHQ-9 is the major depressive disorder (MDD) module of the full PHQ. Used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. Scores each of the 9 Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days, and healthcare utilization.

  2 months

Study Arms (2)

Intervention

EXPERIMENTAL

The investigators will recruit 15 Latino caregivers for each study arm (total sample size of 30). The sample size was based on a rule of thumb of 12 to 15 participants per group for pilot studies. This group will have access to the app.

Behavioral: STAR-C Virtual Training and Follow-up (STAR-VTF)

Control

NO INTERVENTION

12 to 15 participants, will not have access to the app.

Interventions

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

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)

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Caregiver who has a diagnosis of ADRD

Sponsors & Collaborators

• University of Washington: lead
• Alzheimer's Association: collaborator

Study Sites (2)

Alzheimer's Association, Washington State Chapter

Lynnwood, Washington, 98036, United States

Location

UW Memory and Brain Wellness Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health

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

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 18, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)