Trauma Informed Care for Newly Resettled Refugees

NCT03288935 | Withdrawn

• 1 other identifier: HM20011389
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Stress; Emotional Stress

Keywords

refugee; trauma-informed case management (TICM); trauma-informed cultural orientation (TICO); PTSD; depression; refugee resettlement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in emotional well-being

  Baseline to 6 months

• Resettlement Outcomes

  Baseline to 6 months

• Change in Social Adaptation

  Baseline to 6 months

Study Arms (4)

Group 1 (TICM only)

ACTIVE COMPARATOR

Assigned to TICM group after reception \& placement.

Behavioral: TICM

Group 2 (TICO only)

ACTIVE COMPARATOR

Assigned to TICO group after reception \& placement.

Behavioral: TICO

Group 3 (TICM & TICO)

ACTIVE COMPARATOR

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

Behavioral: TICM; Behavioral: TICO

Group 4 (None)

NO INTERVENTION

No additional intervention after reception \& placement

Interventions

TICM 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 1 (TICM only); Group 3 (TICM & TICO)

TICO 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 2 (TICO only); Group 3 (TICM & TICO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Hyojin Im, PhD

  Virginia Commonwealth Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: August 28, 2018
• Primary Completion: March 20, 2019
• Study Completion: May 15, 2019
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (1)