- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05031247
Refugee Mental Health and Wellness Pilot Study
September 1, 2022 updated by: Hafifa Siddiq, PhD, RN, MSN, University of California, Los Angeles
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 Arab Americans 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 countries of origin 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 Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hafifa Siddiq, PhD
- Phone Number: 3105625117
- Email: hafifasiddiq@ucla.edu
Study Contact Backup
- Name: Cristina Punzalan
- Phone Number: 8188086964
- Email: CPunzalan@mednet.ucla.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults who self-identify as Arab or Middle Eastern/North Africa over the age of 55
Exclusion Criteria:
- For all participants, those who do not have the capacity to consent to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Community Navigator Social Support
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.
|
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.
Other Names:
|
|
NO_INTERVENTION: Program Support as Usual
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lubben Social Support Network Scale
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-9 Item Depression Scale
Time Frame: 12 weeks
|
Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9).
The PHQ9 is a nine-item self-report measure of depression.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hafifa Siddiq, PhD, UCLA and Charles R. Drew University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2022
Primary Completion (ANTICIPATED)
July 1, 2023
Study Completion (ANTICIPATED)
August 1, 2023
Study Registration Dates
First Submitted
June 11, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (ACTUAL)
September 1, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 2, 2022
Last Update Submitted That Met QC Criteria
September 1, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 21-000174
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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