Trauma Informed Care for Newly Resettled Refugees

Emotional Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03288935
• Other study ID #: HM20011389
• Status: Withdrawn
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: November 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 15, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Emotional Stress
• Mental Stress
• Stress, Psychological

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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