Social IsolationNCT05031247
Refugee Mental Health and Wellness Pilot Study
A study testing Wellbeing Program in people with Social Isolation, run by University of California, Los Angeles.
Trial summary
This pilot study will develop and examine the acceptability of a Community Navigator program of support for 10-24 older adult immigrant participants receiving services at a refugee-serving organization based in Southern California. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation
- What is being tested?
- Wellbeing Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults who self-identify as being born in the Middle Eastern/North Africa or South Asia region and over the age of 55
Who cannot join
- For all participants, those who do not have the capacity to consent to participate.
About this study
Official title: Mental Health and Wellness Pilot Study Among Aging Immigrants and Refugees
This pilot study will develop and examine the acceptability of a Community Navigator program of support for 10-24 older adult immigrant participants receiving services at a refugee-serving organization based in Southern California. This program will provide participants with social support from a 'Community Navigator,' who will work with clients to help promote attendance and engagement with the community during social activities and community events. This program aims to reduce feelings of loneliness or social isolation. In partnership with the refugee-serving organization, the UCLA investigators will implement this program in addition to services provided as usual at the community partner site. Researchers will then conduct interviews to explore participants' experiences and perceptions for improvement of the program.
Read the detailed description
The Refugee Mental Health and Wellness Pilot Study aims to increase community connections and reduce loneliness for older adult immigrants and refugees, specifically from MENA and South Asia region through the implementation of a Community Navigator program. This program will be implemented within an existing aging program for older adults at a refugee-serving organization that provides social services, English language classes, and computer classes for this population. The pilot program is an extension of case management services at this organization. The program provides up to ten weekly virtual (through video or telephone) home-visiting sessions. During these sessions, an Arabic-speaking program coordinator or an Arabic-speaking nurse will assess client wellbeing, social service needs, as well as referral to social activities and other services needed over three months. The coordinator or nurse will be trained in a trauma-informed approach to working with refugee and immigrant clients. Participants will be recruited at the partner site. This study aims to recruit between 10-24 older adults interested in participating in semi-structured interviews to examine program acceptability and explore suggestions on improving the program. The baseline and completion survey will collect data on social demographics, social support, depressive symptoms, and loneliness score. Interviews will be conducted at least 6-8 weeks upon enrollment in the program. This pilot study will provide preliminary evidence of the acceptability of Community Navigator support and trial evaluation procedures for testing this. The results will inform a future feasibility study and potentially, and potentially, a randomized controlled trial of this intervention.
- Conditions
- Social Isolation
- Being tested
- Wellbeing Program
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellbeing ProgramOther
Also called Community Navigator
The community navigator program was developed during a three-phase community-based participatory research project that aims to examine emotional/mental health needs and address access to mental health services among immigrants and refugees from Muslim-majority countries.
| Study group | Role | What they receive |
|---|---|---|
| Community Navigator Social Support | Experimental | More intensive case management and weekly check-ins with older adults. The Community Navigator will be focused on increasing social contact and connection for older adult refugees and immigrants. Those who receive the intervention will be offered up to ten (30-minute-long) meetings with a Community Navigator and access to up to three group sessions over a 3-month period, alongside the standard services they receive for enrollment with the organization. Receives: Other: Wellbeing Program |
| Program Support as Usual | No intervention | Standard program support will be provided to participants enrolled. These services are offered to all enrolled in the program and may include, but is not limited to the following: financial assistance services, case management, healthcare access services, employment and tax services, education services, citizenship and immigration services, community services and civic engagement, and refugee services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised UCLA Loneliness Scale (R-UCLA)
Decreased loneliness will be measured using the Revised UCLA Loneliness Scale (R-UCLA). This scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
Measured: 12 weeks
Secondary outcomes (1)
Lubben Social Support Network Scale
Perceived social support will be measured using the Lubben Social Support Network scale. The Lubben Social Network Scale is a six-item self-report measure assessing quantity and quality of contact with family and friends.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Why it stopped: Investigator has left UCLA and the study is closed without enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafifa Siddiq, PhD, Principal investigator, UCLA and Charles R. Drew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031247
- Sponsor's protocol ID
- 21-000174
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small participant sample size and vulnerable population (older adult refugees) and risk for exposing personally identifiable information within qualitative interview data, IPD will not be shared with other researchers outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Wellness Pilot Study Among Aging Immigrants and Refugees
- ClinicalTrials.gov ID
- NCT05031247
- Acronym / sponsor ID
- 21-000174
- Conditions
- Social Isolation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator has left UCLA and the study is closed without enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will develop and examine the acceptability of a Community Navigator program of support for 10-24 older adult immigrant participants receiving services at a refugee-serving organization based in Southern California. This program will provide participants with social support from a 'Community Navigator,' who will work with clients to help promote attendance and engagement with the community during social activities and community events. This program aims to reduce feelings of loneliness or social isolation. In partnership with the refugee-serving organization, the UCLA investigators will implement this program in addition to services provided as usual at the community partner site. Researchers will then conduct interviews to explore participants' experiences and perceptions for improvement of the program.
Detailed description
The Refugee Mental Health and Wellness Pilot Study aims to increase community connections and reduce loneliness for older adult immigrants and refugees, specifically from MENA and South Asia region through the implementation of a Community Navigator program. This program will be implemented within an existing aging program for older adults at a refugee-serving organization that provides social services, English language classes, and computer classes for this population. The pilot program is an extension of case management services at this organization. The program provides up to ten weekly virtual (through video or telephone) home-visiting sessions. During these sessions, an Arabic-speaking program coordinator or an Arabic-speaking nurse will assess client wellbeing, social service needs, as well as referral to social activities and other services needed over three months. The coordinator or nurse will be trained in a trauma-informed approach to working with refugee and immigrant clients. Participants will be recruited at the partner site. This study aims to recruit between 10-24 older adults interested in participating in semi-structured interviews to examine program acceptability and explore suggestions on improving the program. The baseline and completion survey will collect data on social demographics, social support, depressive symptoms, and loneliness score. Interviews will be conducted at least 6-8 weeks upon enrollment in the program. This pilot study will provide preliminary evidence of the acceptability of Community Navigator support and trial evaluation procedures for testing this. The results will inform a future feasibility study and potentially, and potentially, a randomized controlled trial of this intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Navigator Social Support | Experimental | Other: Wellbeing ProgramMore intensive case management and weekly check-ins with older adults. The Community Navigator will be focused on increasing social contact and connection for older adult refugees and immigrants. Those who receive the intervention will be offered up to ten (30-minute-long) meetings with a Community Navigator and access to up to three group sessions over a 3-month period, alongside the standard services they receive for enrollment with the organization. |
| Program Support as Usual | No intervention | –Standard program support will be provided to participants enrolled. These services are offered to all enrolled in the program and may include, but is not limited to the following: financial assistance services, case management, healthcare access services, employment and tax services, education services, citizenship and immigration services, community services and civic engagement, and refugee services. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults who self-identify as being born in the Middle Eastern/North Africa or South Asia region and over the age of 55
Key exclusion criteria (1 listed)
- For all participants, those who do not have the capacity to consent to participate.
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 |
|---|---|---|
| Wellbeing ProgramAlso: Community NavigatorThe community navigator program was developed during a three-phase community-based participatory research project that aims to examine emotional/mental health needs and address access to mental health services among immigrants and refugees from Muslim-majority countries. | Other | Community Navigator Social Support |
Primary outcome
Revised UCLA Loneliness Scale (R-UCLA)
Time frame: 12 weeks
Decreased loneliness will be measured using the Revised UCLA Loneliness Scale (R-UCLA). This scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
1 secondary outcome
Lubben Social Support Network Scale
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Due to the small participant sample size and vulnerable population (older adult refugees) and risk for exposing personally identifiable information within qualitative interview data, IPD will not be shared with other researchers outside the research team.
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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.
Hafifa Siddiq, PhD principal investigator
UCLA and Charles R. Drew University
Questions about this trial
What is this clinical trial studying?
A study testing Wellbeing Program in people with Social Isolation, run by University of California, Los Angeles.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Revised UCLA Loneliness Scale (R-UCLA) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.