Demonstrating the Efficacy of a Spanish-Language Program for Latino Dementia Caregivers

NCT ID: NCT06747637

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2028-06-30

Brief Summary

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The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational and skill-building intervention for 226 Spanish-speaking family caregivers in California.

Detailed Description

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The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational and skill-building intervention for 226 Spanish-speaking family caregivers in California.

Based on a wait list trial design, and 4 observation points (baseline, post-intervention, 3-month and 6-month follow-ups), the investigators propose to demonstrate the efficacy of this new intervention (Aim 1), and evaluate for potential moderating conditions across subgroups (Aim 2; age, gender, educational level, etc.). Based on this quantitative component, the investigators will answer the following two aims:

Aim #1. (Efficacy) Compared to a waitlist control group, is Unidos efficacious with regards to primary outcomes-PHQ-9 depression symptoms, RMBPC reactivity to memory and behavior problems, anxiety symptoms, and secondary outcomes-caregiver mastery, competence, and meaning over time?

Aim #2: (Moderators). Do moderating conditions exist such that the intervention is more or less efficacious for subgroups based on age, gender, PLWD functioning?

Qualitative component: After class completion, the investigators will draw from 40-50 focus group participants to elucidate the satisfaction and acceptability of the program. Both Unidos and wait list control participants will be randomly selected for focus group interviews which will be guided by open-ended inquiries around the nuanced, in-depth perspectives of program participation, acceptability, and recommendations (Aim 3).

Aim #3: (Experience/Satisfaction). Will qualitative reports from focus groups signal satisfaction, nuanced differences with respect to the nature, structure, cultural/ language considerations of Unidos, and recommendations?

Based on the scientific team and community partner's established expertise in dementia care, caregiving services, and underrepresented groups, the project is well positioned to address the linguistic and cultural preferences and needs of diverse Californians and the providers that serve them.

Conditions

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Caregiver Burden of People With Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A: Treatment Group Receives the Classes Soon after Randomization

The Spanish-language caregiver classes are called Unidos en el Cuidado and are taught online by Alzheimer's Los Angeles. Sessions are provided at no cost and held weekly for about 2 hours.

Group Type EXPERIMENTAL

Skill-building classes

Intervention Type OTHER

Unidos en el Cuidado is a manualized, multi-family group intervention provided at no cost vis-à-vis videoconferencing or on-site by trained facilitators Sessions are held weekly for 1.5 hours. Class components include caregiver role identity; skills-building; knowledge attainment; attitudinal changes; resource-sharing; practice/role-plays; homework; videos, handouts. Classes will be provided online with some classes offered in the community, if available

Group B: Wait List Control Group Receives the Classes after a Waiting Period

This wait list control group receives the same classes but after a 3-4 week waiting period.

Group Type ACTIVE_COMPARATOR

Wait list control group

Intervention Type OTHER

The intervention is the same; the wait period is longer to receive the intervention described in Group A.

Interventions

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Skill-building classes

Unidos en el Cuidado is a manualized, multi-family group intervention provided at no cost vis-à-vis videoconferencing or on-site by trained facilitators Sessions are held weekly for 1.5 hours. Class components include caregiver role identity; skills-building; knowledge attainment; attitudinal changes; resource-sharing; practice/role-plays; homework; videos, handouts. Classes will be provided online with some classes offered in the community, if available

Intervention Type OTHER

Wait list control group

The intervention is the same; the wait period is longer to receive the intervention described in Group A.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* identifies with being Hispanic or Latino descent
* speaks and reads Spanish
* dementia family caregivers living (or recently lived) in California or whose care recipient lives (or recently lived) in California
* who identify as women, men, or non-binary,
* age 18 years or older

Exclusion Criteria

* Severe sensory or physical conditions that interfere with ongoing participation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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California Department of Public Health

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Maria P. Aranda

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria P Aranda, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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University of Southern California

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maria P Aranda, PhD

Role: CONTACT

(213) 740-1887

Facility Contacts

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Maria P Aranda, PhD

Role: primary

213-740-1887

References

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Griffiths PC, Kovaleva M, Higgins M, Langston AH, Hepburn K. Tele-Savvy: An Online Program for Dementia Caregivers. Am J Alzheimers Dis Other Demen. 2018 Aug;33(5):269-276. doi: 10.1177/1533317518755331. Epub 2018 Mar 16.

Reference Type BACKGROUND
PMID: 29544342 (View on PubMed)

Other Identifiers

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AWD-00008709

Identifier Type: -

Identifier Source: org_study_id

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