University of Southern California
Los Angeles, California, 90089, United States
Location status: Recruiting
NCT Number: NCT06747637
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90089, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
The intervention is the same; the wait period is longer to receive the intervention described in Group A.
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
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:
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
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
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
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
Contact information is provided by the study sponsor or research team.
University of Southern California
Other
Demonstrating the Efficacy of "Unidos en el Cuidado" (United in Caring): A Spanish-Language Program for Latino Caregivers of Persons Living With Dementia
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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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