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

NCT06747637

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
California Department of Public Health	OTHER

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: Treatment Group Receives the Classes Soon after Randomization	Experimental	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
Group B: Wait List Control Group Receives the Classes after a Waiting Period	Active Comparator	This wait list control group receives the same classes but after a 3-4 week waiting period.	Other: Wait list control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Measure	Description	Time Frame
Caregiver Mastery	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

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Maria P Aranda, PhD	Contact	(213) 740-1887		aranda@usc.edu

Name	Affiliation	Role
Maria P Aranda, PhD	University of Southern California	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California	Recruiting	Los Angeles	California	90089	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29544342	Background	Griffiths PC, Kovaleva M, Higgins M, Langston AH, Hepburn K. Tele-Savvy: An Online Program for Dementia Caregivers. Am J Alzheimers Dis Other Demen. 2018 Aug;33(5):269-276. doi: 10.1177/1533317518755331. Epub 2018 Mar 16.

IPD Sharing Statement Module