Caregivers of People With DementiaCuidandoJuntosNCT06394388
A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)
A study testing Cuidando juntos in people with Caregivers of People With Dementia, run by University of Rochester at 1 site in United States.
Trial summary
This study will test the feasibility and influence of a behavioral intervention called "Cuidando Juntos" in Latino caregivers of people with dementia. The study will examine if the intervention is well received by Latino caregivers and if the caregivers' social connectedness and loneliness is associated with their… Read more about this study
- Who is it for?
- Ages 39 years and older
- Conditions the study is for
- Caregivers of People With Dementia
- What is being tested?
- Cuidando juntos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 8 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 39 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spanish speaking
- Latino caregivers are those who identify as the primary caregivers of a person with dementia, with whom they co-reside or live close by.
- must have an email address and access to the internet
- Caregivers should report at least a moderate level of stress
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Charlotte
Charlotte, North Carolina, 28223
About this study
This study will test the feasibility and influence of a behavioral intervention called "Cuidando Juntos" in Latino caregivers of people with dementia. The study will examine if the intervention is well received by Latino caregivers and if the caregivers' social connectedness and loneliness is associated with their levels of stress, burden, and depression.
- Conditions
- Caregivers of People With Dementia
- Being tested
- Cuidando juntos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuidando juntosBehavioural
Caregiver TLC program will be culturally tailored by including a focus on addressing cultural values to promote social connectedness and translated into Spanish (Cuidando Juntos).
Cuidando Juntos consists of 8 modules: stress management; behavioral activation; building resilience; building self-care skills; managing difficult emotions; reducing isolation; and two on understanding and responding to difficult behaviors of the PLWD.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Not described Receives: Behavioral: Cuidando juntos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in PHQ-9 to Assess Depressive Symptoms
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).The scale ranges from 0-27, with higher scores indicating higher depression.
Measured: Baseline to six weeks
Mean Change in Perceived Stress Scale
The perceived stress scale is a 4-item questionnaire, with a score range of 0 to 16. Higher scores are correlated with more stress.
Measured: Baseline to six weeks
Mean Change in Zarit Caregiver Burden 6-item Version
The Zarit caregiver burden 6-item version is a self-administered instrument that ranges from 0-88. Higher scores indicate more burden.
Measured: Baseline to six weeks
Mean Change in Caregiver Self-Efficacy Scale (CSES-8)
The caregiver self-efficacy scale is an 8-item scale developed to reflect components of typical caregiver support interventions that range from 0 to 8. Higher scores indicate being more confident.
Measured: Baseline to six weeks
Secondary outcomes (2)
Mean Change in Social Network Scale
The Social network scale is a self-report measure of social engagement that includes engagement with family and friends.The Short version, a 6-item scale, is used. The scale ranges from 0 to 35; higher scores indicate better outcome.
Measured: Baseline to six weeks
Mean Change in UCLA Loneliness Scale
The UCLA loneliness scale is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The scale measures from 0 to 60; higher scores indicate more loneliness.
Measured: Baseline to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 May 2024
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregivers of People With DementiaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Charlotte, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Julian Montoro-Rodriguez, University of North Carolina, Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394388
- Sponsor's protocol ID
- 24-0291-01
- Other IDs
- 5P30AG064103
- Acronym
- CuidandoJuntos
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2024
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montoro-Rodriguez J, Reeve CL, Gallagher-Thompson D, Ramsey J, Choryan Bilbrey A, Kajiyama B, Quinones MM. Supporting Hispanic caregiver subjective health and well-being: a test of user-reactions and preliminary efficacy of a psychoeducational program for Hispanic dementia caregivers. Gerontologist. 2026 May 11;66(6):gnag029. doi: 10.1093/geront/gnag029.
PubMed 41849439
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)
- ClinicalTrials.gov ID
- NCT06394388
- Acronym / sponsor ID
- CuidandoJuntos / 24-0291-01
- Conditions
- Caregivers of People With Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- University of North Carolina, Charlotte, National Institute on Aging (NIA)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the feasibility and influence of a behavioral intervention called "Cuidando Juntos" in Latino caregivers of people with dementia. The study will examine if the intervention is well received by Latino caregivers and if the caregivers' social connectedness and loneliness is associated with their levels of stress, burden, and depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Behavioral: Cuidando juntos |
Who may qualify
- Ages
- 39 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spanish speaking
- Latino caregivers are those who identify as the primary caregivers of a person with dementia, with whom they co-reside or live close by.
- must have an email address and access to the internet
- Caregivers should report at least a moderate level of stress
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Cuidando juntosCaregiver TLC program will be culturally tailored by including a focus on addressing cultural values to promote social connectedness and translated into Spanish (Cuidando Juntos). Cuidando Juntos consists of 8 modules: stress management; behavioral activation; building resilience; building self-care skills; managing difficult emotions; reducing isolation; and two on understanding and responding to difficult behaviors of the PLWD. | Behavioural | All participants |
Primary outcome
Mean Change in PHQ-9 to Assess Depressive Symptoms
Time frame: Baseline to six weeks
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).The scale ranges from 0-27, with higher scores indicating higher depression.
Mean Change in Perceived Stress Scale
Time frame: Baseline to six weeks
The perceived stress scale is a 4-item questionnaire, with a score range of 0 to 16. Higher scores are correlated with more stress.
Mean Change in Zarit Caregiver Burden 6-item Version
Time frame: Baseline to six weeks
The Zarit caregiver burden 6-item version is a self-administered instrument that ranges from 0-88. Higher scores indicate more burden.
Mean Change in Caregiver Self-Efficacy Scale (CSES-8)
Time frame: Baseline to six weeks
The caregiver self-efficacy scale is an 8-item scale developed to reflect components of typical caregiver support interventions that range from 0 to 8. Higher scores indicate being more confident.
2 secondary outcomes
Mean Change in Social Network Scale
Time frame: Baseline to six weeks
Mean Change in UCLA Loneliness Scale
Time frame: Baseline to six weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41849439Montoro-Rodriguez J, Reeve CL, Gallagher-Thompson D, Ramsey J, Choryan Bilbrey A, Kajiyama B, Quinones MM. Supporting Hispanic caregiver subjective health and well-being: a test of user-reactions and preliminary efficacy of a psychoeducational program for Hispanic dementia caregivers. Gerontologist. 2026 May 11;66(6):gnag029. doi: 10.1093/geront/gnag029.
- Individual participant dataSharing planned: No
Related trials for Caregivers of People With Dementia
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
RecruitingPhase 2
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
Stress
Recruiting
Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
Cognitive Impairment, Mild, Dementia, Mild
Recruiting
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia
BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cuidando juntos in people with Caregivers of People With Dementia, run by University of Rochester 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 4 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: finished, as of the sponsor's last update on 29 Apr 2026. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in PHQ-9 to Assess Depressive Symptoms (time frame: Baseline to six weeks). The study lists 4 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 NCT06394388, 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 29 Apr 2026.