Recruiting

Unidos

Sponsor:

University of Southern California

Code:

NCT06747637

Conditions

Caregiver Burden of People With Dementia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Skill-building classes

Wait list control group

Study Details

Brief 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.

Conditions

Caregiver Burden of People With Dementia

Study ID

NCT06747637

Start date

Jun 4, 2025

Status verified date

Jun, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Severe sensory or physical conditions that interfere with ongoing participation.

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group A: Treatment Group Receives the Classes Soon after Randomization

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.

active comparator: Group B: Wait List Control Group Receives the Classes after a Waiting Period

This wait list control group receives the same classes but after a 3-4 week waiting period.

Interventions

Skill-building classes

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 group

The intervention is the same; the wait period is longer to receive the intervention described in Group A.

Primary outcome measure

  • Depressive symptoms [ Time Frame: 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 [ Time Frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline ]
  • Anxiety symptoms [ Time Frame: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline ]

Central Contacts and Locations

Central contacts

Maria P Aranda, PhD

(213) 740-1887aranda@usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

Maria P Aranda, PhD

213-740-1887aranda@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Jun 6, 2025

Last verified

Jun, 2025

Keywords

  • wait list control interventional study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2025-06-06.