Trial Outcomes & Findings for A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS) (NCT NCT06394388)
NCT ID: NCT06394388
Last Updated: 2026-04-29
Results Overview
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.
COMPLETED
NA
31 participants
Baseline to six weeks
2026-04-29
Participant Flow
Participant milestones
| Measure |
All Participants
Cuidando 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 6 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.
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|---|---|
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Overall Study
STARTED
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31
|
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Overall Study
COMPLETED
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29
|
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)
Baseline characteristics by cohort
| Measure |
All Participants
n=31 Participants
Cuidando 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 6 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.
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|---|---|
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Age, Continuous
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55 years
STANDARD_DEVIATION 8.75 • n=9 Participants
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Sex: Female, Male
Female
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30 Participants
n=9 Participants
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Sex: Female, Male
Male
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1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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31 Participants
n=9 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=9 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
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31 participants
n=9 Participants
|
|
Income
Not Reported
|
13 Participants
n=9 Participants
|
|
Income
15K to 75K
|
18 Participants
n=9 Participants
|
|
Education
Primary 1-6
|
1 Participants
n=9 Participants
|
|
Education
Secondary 7-8
|
10 Participants
n=9 Participants
|
|
Education
Superior 9-12
|
11 Participants
n=9 Participants
|
|
Education
University
|
9 Participants
n=9 Participants
|
|
Marital status
Married
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22 Participants
n=9 Participants
|
|
Marital status
Divorce
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6 Participants
n=9 Participants
|
|
Marital status
Single
|
3 Participants
n=9 Participants
|
|
Work status
Part-time
|
5 Participants
n=9 Participants
|
|
Work status
Full-time
|
7 Participants
n=9 Participants
|
|
Work status
Not working
|
19 Participants
n=9 Participants
|
|
Years providing care
Less than 1 yr
|
8 Participants
n=9 Participants
|
|
Years providing care
2-5 yrs
|
8 Participants
n=9 Participants
|
|
Years providing care
More than 5 yrs
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15 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline to six weeksPopulation: We have 6 pre trial participants that were not included in the analysis
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.
Outcome measures
| Measure |
All Participants
n=25 Participants
Cuidando 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 6 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.
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|---|---|
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Mean Change in PHQ-9 to Assess Depressive Symptoms
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1.6 score on a scale
Standard Deviation 2.71
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PRIMARY outcome
Timeframe: Baseline to six weeksPopulation: We have 6 pre trial participants that were not included in the analysis
The perceived stress scale is a 4-item questionnaire, with a score range of 0 to 16. Higher scores are correlated with more stress.
Outcome measures
| Measure |
All Participants
n=25 Participants
Cuidando 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 6 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.
|
|---|---|
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Mean Change in Perceived Stress Scale
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1.32 score on a scale
Standard Deviation 2.01
|
PRIMARY outcome
Timeframe: Baseline to six weeksPopulation: We have 6 pre trial participants that were not included in the analysis
The Zarit caregiver burden 6-item version is a self-administered instrument that ranges from 0-88. Higher scores indicate more burden.
Outcome measures
| Measure |
All Participants
n=25 Participants
Cuidando 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 6 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.
|
|---|---|
|
Mean Change in Zarit Caregiver Burden 6-item Version
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2.92 score on a scale
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Baseline to six weeksPopulation: We have 6 pre trial participants that were not included in the analysis
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.
Outcome measures
| Measure |
All Participants
n=25 Participants
Cuidando 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 6 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.
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|---|---|
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Mean Change in Caregiver Self-Efficacy Scale (CSES-8)
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1.73 score on a scale
Standard Deviation 1.48
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SECONDARY outcome
Timeframe: Baseline to six weeksPopulation: We have 6 pre trial participants that were not included in the analysis
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.
Outcome measures
| Measure |
All Participants
n=25 Participants
Cuidando 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 6 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.
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|---|---|
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Mean Change in Social Network Scale
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.96 score on a scale
Standard Deviation 4.04
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SECONDARY outcome
Timeframe: Baseline to six weeksPopulation: We have 6 pre trial participants that were not included in the analysis
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.
Outcome measures
| Measure |
All Participants
n=25 Participants
Cuidando 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 6 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.
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|---|---|
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Mean Change in UCLA Loneliness Scale
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7.96 score on a scale
Standard Deviation 8.64
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Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Julian Montoro-Rodriguez, PI
University of North Carolina at Charlotte
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place