Demonstrating the Efficacy of a Spanish-Language Program for Latino Dementia Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
Severe sensory or physical conditions that interfere with ongoing participation.
Trial design
Design model
Parallel
Treatments tested in this trial
Skill-building classes
Other interventionUnidos 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 interventionThe intervention is the same; the wait period is longer to receive the intervention described in Group A.
Treatment groups
225 Participants
are divided into 2 treatment groupsGroup A: Group A: Treatment Group Receives the Classes Soon after RandomizationExperimental treatment 1 intervention
Group B: Group B: Wait List Control Group Receives the Classes after a Waiting PeriodActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depressive symptoms
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 baseline2
Presence and reaction to memory and behavior problems shown by person with dementia
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
Time frame
baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline3
Anxiety symptoms
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 baselineSecondary outcomes
1
Caregiver Mastery
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 baseline2
Caregiver Competence
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 baseline3
Caregiver Meaning
Caregiver Meaning standardized scale: min. to max values=0 to 24; higher values indicate better outcomes
Time frame
baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
California Department of Public Health
Collaborator
Source ClinicalTrials.gov