Spanish-Language Program for Dementia Caregiver Burden

Overseen By Maria P Aranda, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Severe sensory or physical conditions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effectiveness of a program called Unidos en el Cuidado® in assisting Spanish-speaking family caregivers of people with dementia. Participants will join group sessions that offer education and skills to ease the burden of caregiving. The trial includes two groups: one begins the classes immediately, while the other starts after a short wait. Spanish-speaking caregivers of Hispanic or Latino descent in California may qualify if they have been caring for a family member with dementia. As an unphased trial, this study provides caregivers with a unique opportunity to gain valuable skills and support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for caregivers?

A previous study showed that Unidos en el Cuidado® was well-tolerated by participants. This program includes online classes designed to assist Spanish-speaking family caregivers of people with dementia. Research shows that these sessions, focusing on education and skill-building, have not caused any significant negative effects. As an educational program rather than a medical one, it is generally considered safe, with no physical side effects. Participants in past studies reported no harm from attending these sessions. Overall, evidence suggests that Unidos en el Cuidado® is a safe option for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Unidos en el Cuidado® because it offers a culturally tailored approach to alleviating caregiver burden for Spanish-speaking families dealing with dementia. Unlike standard caregiver support programs, which may not adequately address language and cultural nuances, this program is specifically designed for Spanish-speaking communities, providing accessible, online classes run by Alzheimer's Los Angeles. This unique focus not only enhances understanding and engagement but also ensures that caregivers receive support that resonates with their cultural experiences, potentially improving their coping skills and reducing stress more effectively than generic programs.

What evidence suggests that Unidos en el Cuidado® is effective for reducing dementia caregiver burden?

This trial will evaluate the effectiveness of the Unidos en el Cuidado program for Spanish-speaking caregivers of people with dementia. Research has shown that programs like Unidos en el Cuidado can lower stress and ease challenges for caregivers. Similar programs, such as the Savvy Caregiver Program, have successfully taught skills and provided support. Studies on programs like REACH OUT and NYUCI showed a noticeable decrease in caregiver stress, with reductions of about 5.2 and 4.6 points, respectively. These findings suggest that programs designed for Spanish-speaking caregivers can effectively help them manage their responsibilities. ^{1 2 6 7 8}

Who Is on the Research Team?

Maria P Aranda, PhD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking family caregivers in California who are taking care of relatives with dementia. The program aims to help them manage the stress and challenges associated with caregiving.

Inclusion Criteria

Dementia family caregivers living (or recently lived) in California or whose care recipient lives (or recently lived) in California

Speaks and reads Spanish

I identify as a woman, man, or non-binary.

Exclusion Criteria

I do not have severe sensory or physical conditions that would stop me from participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Unidos en el Cuidado intervention, consisting of 3 weekly online sessions, each lasting about 2 hours

3 weeks

3 visits (virtual)

Follow-up

Participants are monitored for primary and secondary outcomes at multiple observation points

6 months

3 visits (virtual)

Qualitative Assessment

Focus group interviews to assess satisfaction and acceptability of the program

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Unidos en el Cuidado®

Trial Overview

The study is testing Unidos en el Cuidado®, a culturally-tailored program consisting of three group sessions designed to educate and build skills for Latino dementia caregivers, against a wait list control group.

How Is the Trial Designed?

Group I: Group A: Treatment Group Receives the Classes Soon after Randomization Experimental Treatment 1 Intervention

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.

Group II: Group B: Wait List Control Group Receives the Classes after a Waiting Period Active Control 1 Intervention

This wait list control group receives the same classes but after a 3-4 week waiting period.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

California Department of Public Health

Collaborator

Trials

7

Recruited

5,800+

Published Research Related to This Trial

A new website, Cuidatecuidador.com, was created to provide bilingual information specifically for Spanish-speaking caregivers of individuals with dementia, addressing a significant gap in culturally appropriate resources.

Evaluation of the website by caregivers from three countries indicated that access to this information may lead to increased feelings of mastery and a decrease in depressive symptoms among caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an online community to provide support to caregivers of people with dementia. Pagán-Ortiz, ME., Cortés, DE., Rudloff, N., et al.[2022]

A Spanish language adaptation of a virtual Mentalizing Imagery Therapy (MIT) program was successfully implemented for 12 Spanish-speaking family caregivers of people with dementia, showing high satisfaction and full participation in the program.

The caregivers experienced a significant reduction in depressive symptoms by week three, which was maintained at a 4-month follow-up, along with improvements in mindfulness, caregiver burden, and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual mentalizing imagery therapy for Spanish language Latino family dementia caregivers: A feasibility and acceptability study. Ramirez-Gomez, L., Johnson, JK., Ritchie, C., et al.[2023]

A study involving 16 Latino caregivers aged 50 to 75 revealed that caregiver responsibilities and health decline were significant sources of burden for those caring for family members with Alzheimer's disease and related dementia.

Cultural values, particularly gender roles, influenced caregivers' experiences, highlighting disparities in support and responsibilities, with women feeling a greater burden due to traditional expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sources of Caregiving Burden in Middle-Aged and Older Latino Caregivers. Balbim, GM., Magallanes, M., Marques, IG., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06747637

NCT06747637 | Demonstrating the Efficacy of a Spanish- ...

The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12138286/

Participant perspectives on online interventions for diverse ...

The Savvy Caregiver Program is an evidence‐based educational and skill‐building training intervention for caregivers of people living with dementia. Informed by ...

3.

researchgate.net

researchgate.net/publication/349703156_Results_of_a_Randomized_Trial_Testing_the_Efficacy_of_Tele-Savvy_an_Online_SynchronousAsynchronous_Psychoeducation_Program_for_Family_Caregivers_of_Persons_Living_with_Dementia

Results of a Randomized Trial Testing the Efficacy of Tele- ...

Expected benefits for caregiver burden and anxiety were not found. Discussion and Implications Findings attest to program efficacy and the viability of ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6157000/

Comparative effectiveness of 2 interventions for Hispanic ...

Both interventions showed a reduction in burden (REACH-OUT = 5.2 points, 95 % confidence interval [CI] = 2.2, 8.1, p < 0.001; NYUCI = 4.6-points ...

5.

pcori.org

pcori.org/research-results/2013/reducing-burden-hispanic-caregivers-relatives-dementia-northern-manhattan-hispanic-caregiver-intervention-effectiveness-study-nhice

Reducing Burden on Hispanic Caregivers of Relatives with ...

Conclusions and Relevance​​ Both NYUCI and REACH OUT were effective in reducing burden and stress among Hispanic caregivers of relatives with dementia, ...

6.

withpower.com

withpower.com/trial/phase-dementia-1-2025-7ad89

Spanish-Language Program for Dementia Caregiver Burden

This N/A medical study run by University of Southern California is evaluating whether Unidos en el Cuidado® will have tolerable side effects & efficacy for ...

7.

policylab.us

policylab.us/clinical-trials/l/california/condition/dementia?page=2

Dementia Paid Clinical Trials in California - Policy Lab

The investigators will test the efficacy of Unidos en el Cuidado® (United ... Conditions: Caregiver Burden of People With Dementia. Register for Updates.

8.

researchgate.net

researchgate.net/publication/370071838_Tele-Savvy_Outcomes_of_Non-Hispanic_Black_American_and_White_Caregivers

Tele-Savvy Outcomes of Non-Hispanic Black American ...

... burden in the face of frequent care demands) affects key dementia caregiving outcomes. The present study utilized data from 1,979 dementia caregivers over a ...