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A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)

A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06394388
Acronym
CuidandoJuntos
Enrollment
31
Registered
2024-05-01
Start date
2024-05-01
Completion date
2025-01-08
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers of People With Dementia

Brief 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 levels of stress, burden, and depression.

Interventions

BEHAVIORALCuidando juntos

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.

Sponsors

University of Rochester
Lead SponsorOTHER
University of North Carolina, Charlotte
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
39 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Mean Change in PHQ-9 to Assess Depressive SymptomsBaseline to six weeksThe 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 ScaleBaseline to six weeksThe 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 VersionBaseline to six weeksThe 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)Baseline to six weeksThe 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.

Secondary

MeasureTime frameDescription
Mean Change in Social Network ScaleBaseline to six weeksThe 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.
Mean Change in UCLA Loneliness ScaleBaseline to six weeksThe 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.

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous55 years
STANDARD_DEVIATION 8.75
Education
Primary 1-6
1 Participants
Education
Secondary 7-8
10 Participants
Education
Superior 9-12
11 Participants
Education
University
9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Income
15K to 75K
18 Participants
Income
Not Reported
13 Participants
Marital status
Divorce
6 Participants
Marital status
Married
22 Participants
Marital status
Single
3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
31 Participants
Region of Enrollment
United States
31 participants
Sex: Female, Male
Female
30 Participants
Sex: Female, Male
Male
1 Participants
Work status
Full-time
7 Participants
Work status
Not working
19 Participants
Work status
Part-time
5 Participants
Years providing care
2-5 yrs
8 Participants
Years providing care
Less than 1 yr
8 Participants
Years providing care
More than 5 yrs
15 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 31
other
Total, other adverse events
0 / 31
serious
Total, serious adverse events
0 / 31

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026