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

Not Applicable

Not yet recruiting

• Conditions: Caregiver Burden of People With Dementia

• Registration Number: NCT06747637
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Study Start: 2025-02-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	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	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	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 Outcome Measures

Name	Time	Method
Caregiver Mastery	baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline	Caregiver Mastery standardized scale: min. to max values=0 to 12; higher values indicate better outcomes
Caregiver Competence	baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline	Caregiver Competence standardized scale: min. to max values=0 to 12; higher values indicate better outcomes
Caregiver Meaning	baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline	Caregiver Meaning standardized scale: min. to max values=0 to 24; higher values indicate better outcomes

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States