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

June 3, 2025 updated by: Maria P. Aranda, University of Southern California

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maria P Aranda, PhD
  • Phone Number: (213) 740-1887
  • Email: aranda@usc.edu

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Recruiting
        • University of Southern California
        • Contact:
          • Maria P Aranda, PhD
          • Phone Number: 213-740-1887
          • Email: aranda@usc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Treatment Group Receives the Classes Soon after Randomization
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.
Other: Skill-building classes
Unidos 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
Active Comparator: Group B: Wait List Control Group Receives the Classes after a Waiting Period
This wait list control group receives the same classes but after a 3-4 week waiting period.
Other: Wait list control group
The intervention is the same; the wait period is longer to receive the intervention described in Group A.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Mastery
Time Frame: 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
baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Caregiver Competence
Time Frame: 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
baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Caregiver Meaning
Time Frame: 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
baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

California Department of Public Health

Investigators

  • Principal Investigator: Maria P Aranda, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 4, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

December 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWD-00008709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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