Caregiver Burden of People With DementiaNCT06747637
Demonstrating the Efficacy of a Spanish-Language Program for Latino Dementia Caregivers
A study testing Skill-building classes in people with Caregiver Burden of People With Dementia, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden of People With Dementia
- What is being tested?
- Skill-building classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe sensory or physical conditions that interfere with ongoing participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
Maria P Aranda, PhD, 213-740-1887, aranda@usc.edu
About this study
Official title: Demonstrating the Efficacy of "Unidos en el Cuidado" (United in Caring): A Spanish-Language Program for Latino Caregivers of Persons Living With Dementia
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.
Read the 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.
- Conditions
- Caregiver Burden of People With Dementia
- Being tested
- Skill-building classes, Wait list control group
- Keywords
- wait list control interventional study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skill-building classesOther
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 groupOther
The intervention is the same; the wait period is longer to receive the intervention described in Group A.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Wait list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Patient Health Questionnaire 9 item standardized scale: min. to max values=0 to 27; higher values indicate worse outcomes
Measured: 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
Measured: 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
Measured: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Secondary outcomes (3)
Caregiver Mastery
Caregiver Mastery standardized scale: min. to max values=0 to 12; higher values indicate better outcomes
Measured: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Caregiver Competence
Caregiver Competence standardized scale: min. to max values=0 to 12; higher values indicate better outcomes
Measured: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Caregiver Meaning
Caregiver Meaning standardized scale: min. to max values=0 to 24; higher values indicate better outcomes
Measured: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start4 Jun 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver Burden of People With DementiaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- California Department of Public Health
- Responsible party
- Principal investigator, Maria P. Aranda, University of Southern California
- Investigators
- Maria P Aranda, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747637
- Sponsor's protocol ID
- AWD-00008709
- Status last verified
- Jun 2025
- First submitted
- 11 Dec 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29544342
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrating the Efficacy of "Unidos en el Cuidado" (United in Caring): A Spanish-Language Program for Latino Caregivers of Persons Living With Dementia
- ClinicalTrials.gov ID
- NCT06747637
- Acronym / sponsor ID
- AWD-00008709
- Conditions
- Caregiver Burden of People With Dementia
- Keywords
- wait list control interventional study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- California Department of Public Health
- Study start
- 4 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Treatment Group Receives the Classes Soon after Randomization | Experimental | Other: Skill-building classesThe 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 B: Wait List Control Group Receives the Classes after a Waiting Period | Active comparator | Other: Wait list control groupThis wait list control group receives the same classes but after a 3-4 week waiting period. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Severe sensory or physical conditions that interfere with ongoing participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skill-building classesUnidos 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 | Other | Group A: Treatment Group Receives the Classes Soon after Randomization |
| Wait list control groupThe intervention is the same; the wait period is longer to receive the intervention described in Group A. | Other | Group B: Wait List Control Group Receives the Classes after a Waiting Period |
Primary outcome
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
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: 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
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
3 secondary outcomes
Caregiver Mastery
Time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Caregiver Competence
Time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Caregiver Meaning
Time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 29544342Griffiths 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria P Aranda, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skill-building classes in people with Caregiver Burden of People With Dementia, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria P Aranda, PhD ((213) 740-1887, aranda@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06747637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.