Clinical trial NCT06747637: Demonstrating the Efficacy of a Spanish-Language Program for Latino Dementia Caregivers
Official title: Demonstrating the Efficacy of "Unidos en el Cuidado" (United in Caring): A Spanish-Language Program for Latino Caregivers of Persons Living With Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden of People With Dementia
Keywords: wait list control interventional study
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: California Department of Public Health
First posted: 2024-12-24
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
measure: Presence and reaction to memory and behavior problems shown by person with dementia
timeFrame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
measure: Anxiety symptoms
timeFrame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Secondary outcomes:
measure: Caregiver Mastery
timeFrame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
measure: Caregiver Competence
timeFrame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
measure: Caregiver Meaning
timeFrame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Maria P Aranda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.