Trauma Informed Care for Newly Resettled Refugees

NCT ID: NCT03288935

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2019-05-15

Brief Summary

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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

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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.

Conditions

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Mental Stress Emotional Stress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1 (TICM only)

Assigned to TICM group after reception \& placement.

Group Type ACTIVE_COMPARATOR

TICM

Intervention Type BEHAVIORAL

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).

Group 2 (TICO only)

Assigned to TICO group after reception \& placement.

Group Type ACTIVE_COMPARATOR

TICO

Intervention Type BEHAVIORAL

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.

Group 3 (TICM & TICO)

Assigned to both TICM and TICO group after reception \& placement.

Group Type ACTIVE_COMPARATOR

TICM

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Group 4 (None)

No additional intervention after reception \& placement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyojin Im, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth Univeristy

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM20011389

Identifier Type: -

Identifier Source: org_study_id

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