Social IsolationNCT04875065
Engage Coaching for Latinos
A study testing Engage coaching in people with Social Isolation and Loneliness, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Social Isolation, Loneliness, Caregiver Burnout
- What is being tested?
- Engage coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos
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
- Being tested
- Engage coaching
- Medical subject headings
- Social Isolation, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engage coachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Engage coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (2)
Change From Baseline in Social Functioning at Post Intervention
Satisfaction with Social Roles and Activities (PROMIS) is a computerized adaptive test (CAT). It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate better outcomes (i.e., greater satisfaction with social role and activities). Mean change in T scores (change = post intervention scores - baseline scores) will be reported.
Measured: Baseline and 3 months
Change From Baseline in Quality of Life: Social Relationships at Post Intervention
The World Health Organization Quality-of-Life Scale: Brief Version (WHOQOL-BREF) is a 36-item measure of several domains (physical health, psychological health, social relationships, environment) of health related quality of life. Higher scores denote higher quality of life. Items are scored on a 1-5 Likert scale. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval for each domain. Mean change in Domain 3 (social relationships) scores (change = post intervention scores - baseline scores) will be reported.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start24 Jan 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Caroline Silva, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875065
- Sponsor's protocol ID
- STUDY00006126
- Other IDs
- P30AG064103
- Status last verified
- Sep 2025
- First submitted
- 30 Apr 2021
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37005703Quinones-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.
PubMed 40929145
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos
- ClinicalTrials.gov ID
- NCT04875065
- Acronym / sponsor ID
- STUDY00006126
- Conditions
- Social Isolation, Loneliness, Caregiver Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Posted 14 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Engage Coaching | Experimental | Behavioral: Engage coachingEngage 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engage coachingParticipants 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. | Behavioural | Engage Coaching |
Primary outcome
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.
2 secondary outcomes
Change From Baseline in Social Functioning at Post Intervention
Time frame: Baseline and 3 months
Change From Baseline in Quality of Life: Social Relationships at Post Intervention
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37005703Quinones 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.
- Results publication: PubMed 40929145Quinones-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engage coaching in people with Social Isolation and Loneliness, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Loneliness at Post Intervention (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04875065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.