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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Wellbeing Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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