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

University of Southern California

Status: Enrolling

Conditions: Caregiver Burden of People With Dementia

Treatments: Other: Skill-building classes; Other: Wait list control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06747637

AWD-00008709

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Group A: Treatment Group Receives the Classes Soon after Randomization

Experimental group

Description:

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.

Treatment:

Other: Skill-building classes

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

Active Comparator group

Description:

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

Treatment:

Other: Wait list control group