Trauma Informed Care for Newly Resettled Refugees
Primary Purpose
Mental Stress, Emotional Stress
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TICM
TICO
Sponsored by
About this trial
This is an interventional other trial for Mental Stress focused on measuring refugee, trauma-informed case management (TICM), trauma-informed cultural orientation (TICO), PTSD, depression, refugee resettlement
Eligibility Criteria
Inclusion Criteria:
- Refugee adults who arrive in Richmond or Charlottesville between January and February 2018
Exclusion Criteria:
-
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Group 1 (TICM only)
Group 2 (TICO only)
Group 3 (TICM & TICO)
Group 4 (None)
Arm Description
Assigned to TICM group after reception & placement.
Assigned to TICO group after reception & placement.
Assigned to both TICM and TICO group after reception & placement.
No additional intervention after reception & placement
Outcomes
Primary Outcome Measures
Change in resettlement distress
Penn State Worry Questionnaire, which captures pervasiveness, excessiveness, and uncontrollability of worry. Scores range from 16 to 80 with higher values indicating more worry.
Secondary Outcome Measures
Change in emotional well-being
Refugee Health Screener-15, a 75 item screening tool with lower scores indicating better well-being
Resettlement Outcomes
Post-Migration Living Difficulties, a self-assessment tool which measures adverse post -migration experiences in five different domains, included two related asylum-seeking factors. Scores range from 23 to 115 with higher values indicating more serious problems.
Change in Social Adaptation
Social Adaptation Self-evaluation Scale. Scores range from 0 to 63 with higher values indicating better social adjustment.
Full Information
NCT ID
NCT03288935
First Posted
September 18, 2017
Last Updated
November 26, 2018
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03288935
Brief Title
Trauma Informed Care for Newly Resettled Refugees
Official Title
Trauma Informed Care for Refugee Newcomers in Virginia: A Factorial Design of Effectiveness-Implementation Hybrid Research
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
A substantial decrease in refugee arrivals in Virginia didn't allow the investigator to continue the study as planned.
Study Start Date
August 28, 2018 (Anticipated)
Primary Completion Date
March 20, 2019 (Anticipated)
Study Completion Date
May 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate early-phase interventions for refugee wellness promotion and build evidence for dissemination of the intervention model and curricula through refugee resettlement programs, local and national.
Detailed Description
This study will examine the main effects of trauma-informed case management (TICM) and trauma-informed cultural orientation (TICO) interventions, respectively, in reducing resettlement distress and increasing coping capacity, which will improve emotional wellness and social adaptation and thus resettlement outcomes. This project will also test the interaction effects of two-tiered intervention model, discerning effective and ineffective components of the intervention model. Differences in effects across intervention conditions may inform how improvement in what outcomes or which phase can affect refugees' wellness and adjustment over time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Stress, Emotional Stress
Keywords
refugee, trauma-informed case management (TICM), trauma-informed cultural orientation (TICO), PTSD, depression, refugee resettlement
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (TICM only)
Arm Type
Active Comparator
Arm Description
Assigned to TICM group after reception & placement.
Arm Title
Group 2 (TICO only)
Arm Type
Active Comparator
Arm Description
Assigned to TICO group after reception & placement.
Arm Title
Group 3 (TICM & TICO)
Arm Type
Active Comparator
Arm Description
Assigned to both TICM and TICO group after reception & placement.
Arm Title
Group 4 (None)
Arm Type
No Intervention
Arm Description
No additional intervention after reception & placement
Intervention Type
Behavioral
Intervention Name(s)
TICM
Intervention Description
The TICM will be designed to include the seven domains of trauma-informed care articulated by SAMHSA (2014): 1) early screening and comprehensive assessment; 2) consumer driven care and services; 3) trauma-informed, responsive and educated workforce; 4) emerging and evidence-informed best practices; 5) safe and secure environments; 6) trauma-informed community partnerships; and 7) a performance monitoring system. The trained agency case managers and staff will provide the TICM to 50 newly resettled refugees during their regular R&P service period (i.e., 60 days).
Intervention Type
Behavioral
Intervention Name(s)
TICO
Intervention Description
The community-based TICO will be based on the Im's CHW that comprises 8 sessions (2 hour per session), co-facilitated by trained refugee peer mentors and community service providers. The TICO sessions will include interactive sessions on healthy eating, healthy body and healthy mind, acculturation & resettlement stress, understanding trauma and stress, healthy coping, helping others, and community building.
Primary Outcome Measure Information:
Title
Change in resettlement distress
Description
Penn State Worry Questionnaire, which captures pervasiveness, excessiveness, and uncontrollability of worry. Scores range from 16 to 80 with higher values indicating more worry.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in emotional well-being
Description
Refugee Health Screener-15, a 75 item screening tool with lower scores indicating better well-being
Time Frame
Baseline to 6 months
Title
Resettlement Outcomes
Description
Post-Migration Living Difficulties, a self-assessment tool which measures adverse post -migration experiences in five different domains, included two related asylum-seeking factors. Scores range from 23 to 115 with higher values indicating more serious problems.
Time Frame
Baseline to 6 months
Title
Change in Social Adaptation
Description
Social Adaptation Self-evaluation Scale. Scores range from 0 to 63 with higher values indicating better social adjustment.
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Refugee adults who arrive in Richmond or Charlottesville between January and February 2018
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyojin Im, PhD
Organizational Affiliation
Virginia Commonwealth Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trauma Informed Care for Newly Resettled Refugees
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