Trauma Informed Care for Newly Resettled Refugees

Not Applicable

Withdrawn

• Conditions: Mental Stress; Emotional Stress
• Interventions: Behavioral: TICM; Behavioral: TICO

• Registration Number: NCT03288935
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Study Start: 2018-08-28
• Primary Completion: 2019-03-20
• Study Completion: 2019-05-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 3 (TICM & TICO)	TICO	Assigned to both TICM and TICO group after reception \& placement.
Group 3 (TICM & TICO)	TICM	Assigned to both TICM and TICO group after reception \& placement.
Group 1 (TICM only)	TICM	Assigned to TICM group after reception \& placement.
Group 2 (TICO only)	TICO	Assigned to TICO group after reception \& placement.

Primary Outcome Measures

Name	Time	Method
Change in resettlement distress	Baseline to 6 months	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

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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States