Engage Coaching for Latinos (NCT04875065) | Clinical Trial Compass
CompletedNot Applicable
Engage Coaching for Latinos
United States10 participantsStarted 2021-01-24
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Loneliness at Post Intervention