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Clinical Trials/NCT06747637
NCT06747637
Recruiting
Not Applicable

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

University of Southern California1 site in 1 country225 target enrollmentJune 4, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregiver Burden of People With Dementia
Sponsor
University of Southern California
Enrollment
225
Locations
1
Primary Endpoint
Depressive symptoms
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 4, 2025
End Date
June 30, 2028
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria P. Aranda

Professor

University of Southern California

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.

Outcomes

Primary Outcomes

Depressive symptoms

Time Frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

Patient Health Questionnaire 9 item standardized scale: min. to max values=0 to 27; higher values indicate worse outcomes

Presence and reaction to memory and behavior problems shown by person with dementia

Time Frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

Revised Memory and Behavior Problems Checklist standardized scale: 1. Symptom presence (yes/no); min. to max values=0 to 24; higher values indicate worse outcomes 2. Symptom reaction: Include only items with frequency scores of 1 to 4 in the reaction scoring. Compute the mean reaction score by summing reaction scores of these items and then dividing by the number of items included in the sum. the range for each subscale is 0 to 4. Higher values indicate worse outcomes

Anxiety symptoms

Time Frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

Generalized Anxiety Disorder 7 item standardized scale: min. to max values=0 to 24; higher values indicate worse outcomes

Secondary Outcomes

  • Caregiver Mastery(baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline)
  • Caregiver Competence(baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline)
  • Caregiver Meaning(baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline)

Study Sites (1)

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