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

Study Contact Backup

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:
  • Community Navigator
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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