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NCT Number: NCT06747637

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90089, United States

Location status: Recruiting

Location contact

Maria P Aranda, PhD

CONTACT

[email protected]

213-740-1887

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skill-building classes

Other

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

Wait list control group

Other

The intervention is the same; the wait period is longer to receive the intervention described in Group A.

Primary outcomes

  1. 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

  2. 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:

    • Symptom presence (yes/no); min. to max values=0 to 24; higher values indicate worse outcomes
    • 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
  3. 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

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria P Aranda, PhD

CONTACT

[email protected]

(213) 740-1887

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • California Department of Public Health

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 24, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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