Engage Coaching for Latinos

NCT04875065 | Completed Results

• 2 other identifiers: STUDY00006126P30AG064103
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study asks: "what behavioral strategies are needed to help socially disconnected Hispanic/Latino caregivers with significant barriers to increasing connectedness?" This study uses a mixed methods approach to adapt a brief behavioral intervention-Social Engage psychotherapy-for use with socially disconnected Hispanic/Latino caregivers. This study is a single-arm clinical trial of Social Engage psychotherapy. We propose to enroll 10 participants for up to 8 weekly individual Social Engage psychotherapy sessions, over up to 3 months. Subjects will be aged 40 and older, and be caregivers for a community-dwelling family member with ADRD, living with (or in close proximity to) the family member with dementia, experiencing elevated caregiving distress and social disconnectedness.

Conditions

Social Isolation; Loneliness; Caregiver Burnout

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Loneliness at Post Intervention

  The UCLA Loneliness Scale Version 3 will be used to assess self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness). Mean change in total scores (change = baseline intervention scores - post scores) will be reported.

  Baseline and 3 months

Secondary Outcomes (2)

• Change From Baseline in Social Functioning at Post Intervention

  Baseline and 3 months

• Change From Baseline in Quality of Life: Social Relationships at Post Intervention

  Baseline and 3 months

Study Arms (1)

Engage Coaching

EXPERIMENTAL

Engage Coaching helps caregivers bolster motivation for increasing connectedness, teaches problem solving skills, and provides behavioral practice with social engagement. Up to 8 brief sessions (typically 30 minutes) are provided weekly over no more than three months.

Behavioral: Engage coaching

Interventions

Engage coaching BEHAVIORAL

Participants will complete up to 8 weekly individual Social Engage psychotherapy sessions. Participants will be allotted up to 3 months to complete all sessions, a time-frame that allows for two weeks without meeting to address life stressors such as illnesses that may pop up. All sessions are provided via phone or videocall (Zoom). The first and last session are longer - up to 60 minutes if needed. Middle sessions are shorter (20-45 minutes). Engage is a stepped care psychotherapy in that the simplest strategy is taught first-action planning (a derivative of problem solving therapy)-and "barrier strategies" are added only if needed. Action plans are designed to address loneliness and social isolation in the context of caregiving demands.

Engage Coaching

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 yrs;
• Hispanic/Latino
• English or Spanish speaking;
• Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
• Endorse elevated caregiving distress as measured by a score of ≥ 11 on the 10-item Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain Index (MCSI);
• Endorse clinically significant loneliness as measured by a score of ≥ 6 on the UCLA Loneliness Scale: Short Form.
• Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.

You may not qualify if:

• Primary language is not English or Spanish;
• Recent or current psychosis;
• Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment;
• Hearing problems that preclude completion of the intervention.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Quinones MM, Silva C, Ross C, Sorensen S, Serrano R, Van Orden K, Heffner K. Recruiting Socially Disconnected Latinos Caring for a Person with Alzheimer's Disease and Related Dementias During the COVID-19 Pandemic: Lessons Learned. Clin Gerontol. 2023 Apr 2:1-14. doi: 10.1080/07317115.2023.2197895. Online ahead of print.

  PMID: 37005703 RESULT

• Quinones-Cordero MM, Norton S, Rivas C, Gallagher-Thompson D, Silva C. Exploring the unmet needs of Latino dementia caregivers: a qualitative study. Gerontologist. 2025 Oct 22;65(11):gnaf191. doi: 10.1093/geront/gnaf191.

  PMID: 40929145 RESULT

MeSH Terms

Conditions

Social Isolation; Caregiver Burden

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Stress, Psychological; Behavioral Symptoms

Results Point of Contact

• Title: Dr. Caroline Silva
• Organization: University of Rochester

caroline_silva@urmc.rochester.edu

585-275-2392

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 6, 2021
• Study Start: January 24, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: October 27, 2025
• Results First Posted: April 14, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)