NCT06747637 · University of Southern California
Demonstrating the Efficacy of a Spanish-Language Program for Latino Dementia Caregivers
What this study is about
The investigators will test the effectiveness 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.
View original scientific 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.
Interventions
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
OTHER
Wait list control group
The intervention is the same; the wait period is longer to receive the intervention described in Group A.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
Collaborators
California Department of Public Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 6, 2025 · Source of record for eligibility and locations