N/A
Completed N=10
Engage Coaching for Latinos
Social Isolation · Loneliness · Caregiver Burnout
Source: ClinicalTrials.gov NCT04875065 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Change From Baseline in Loneliness at Post Intervention — 51.125000; 53.000000 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Loneliness at Post Intervention |
51.125000; 53.000000 | — |
| SECONDARY Change From Baseline in Social Functioning at Post Intervention |
41.332143; 41.875000 | — |
| SECONDARY Change From Baseline in Quality of Life: Social Relationships at Post Intervention |
41.687500; 42.250000 | — |
Eligibility Criteria
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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04875065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.