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Clinical Trials/NCT04875065
NCT04875065CompletedNot Applicable

Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos

University of Rochester1 site in 1 country10 target enrollmentStarted: January 24, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Change From Baseline in Loneliness at Post Intervention

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Engage coaching (Behavioral)

Outcomes

Primary Outcomes

Change From Baseline in Loneliness at Post Intervention

Time Frame: Baseline and 3 months

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Caroline Silva

Assistant Professor

University of Rochester

Study Sites (1)

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