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RecruitingNCT06747637

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

Demonstrating the Efficacy of "Unidos en el Cuidado" (United in Caring): A Spanish-Language Program for Latino Caregivers of Persons Living With Dementia

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
225 (estimated)
Sponsor
University of Southern California · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Accepted

Summary

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

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

Interventions

TypeNameDescription
OTHERSkill-building classesUnidos 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
OTHERWait list control groupThe intervention is the same; the wait period is longer to receive the intervention described in Group A.

Timeline

Start date
2025-06-04
Primary completion
2028-06-30
Completion
2028-06-30
First posted
2024-12-24
Last updated
2025-06-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06747637. Inclusion in this directory is not an endorsement.