Trauma Informed Care for Newly Resettled Refugees

Trauma Informed Care for Refugee Newcomers in Virginia: A Factorial Design of Effectiveness-Implementation Hybrid Research

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.

Study Overview

• Status: Withdrawn
• Conditions: Emotional Stress; Mental Stress
• Intervention / Treatment: Behavioral: TICM; Behavioral: TICO

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Refugee adults who arrive in Richmond or Charlottesville between January and February 2018

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (TICM only); Assigned to TICM group after reception & placement.	Behavioral: TICM; 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).
Active Comparator: Group 2 (TICO only); Assigned to TICO group after reception & placement.	Behavioral: TICO; 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.
Active Comparator: Group 3 (TICM & TICO); Assigned to both TICM and TICO group after reception & placement.	Behavioral: TICM; 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).; Behavioral: TICO; 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.
No Intervention: Group 4 (None); No additional intervention after reception & placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotional well-being	Refugee Health Screener-15, a 75 item screening tool with lower scores indicating better well-being	Baseline to 6 months
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.	Baseline to 6 months
Change in Social Adaptation	Social Adaptation Self-evaluation Scale. Scores range from 0 to 63 with higher values indicating better social adjustment.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Hyojin Im, PhD, Virginia Commonwealth Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): March 20, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; depression; refugee; trauma-informed case management (TICM); trauma-informed cultural orientation (TICO); refugee resettlement
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: HM20011389

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No