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Completed

NCT Number: NCT06394388

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

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.

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Key information

Conditions

Caregivers of People With Dementia

Age range

39 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Charlotte

Charlotte, North Carolina, 28223, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cuidando juntos

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Mean Change in Social Network Scale

    Time frame: Baseline to six weeks

    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.

  2. Mean Change in UCLA Loneliness Scale

    Time frame: Baseline to six weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)
  • University of North Carolina, Charlotte

Registry information

Acronym: CuidandoJuntos

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 1, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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