Mental StressNCT03288935
Trauma Informed Care for Newly Resettled Refugees
A study testing TICM and TICO in people with Mental Stress and Emotional Stress, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Stress, Emotional Stress
- What is being tested?
- TICM and TICO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2018to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refugee adults who arrive in Richmond or Charlottesville between January and February 2018
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Stress, Emotional Stress
- Being tested
- TICM, TICO
- Keywords
- refugee, trauma-informed case management (TICM), trauma-informed cultural orientation (TICO), PTSD, depression, refugee resettlement
- Medical subject headings
- Stress, Psychological, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TICMBehavioural
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).
TICOBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (TICM only) | Active comparator | Assigned to TICM group after reception \& placement. Receives: Behavioral: TICM |
| Group 2 (TICO only) | Active comparator | Assigned to TICO group after reception \& placement. Receives: Behavioral: TICO |
| Group 3 (TICM & TICO) | Active comparator | Assigned to both TICM and TICO group after reception \& placement. Receives: Behavioral: TICM; Behavioral: TICO |
| Group 4 (None) | No intervention | No additional intervention after reception \& placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (3)
Change in emotional well-being
Refugee Health Screener-15, a 75 item screening tool with lower scores indicating better well-being
Measured: 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.
Measured: 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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start28 Aug 2018
- Primary completion20 Mar 2019
- Study completion15 May 2019
Why it stopped: A substantial decrease in refugee arrivals in Virginia didn't allow the investigator to continue the study as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyojin Im, PhD, Principal investigator, Virginia Commonwealth Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288935
- Sponsor's protocol ID
- HM20011389
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2017
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Informed Care for Refugee Newcomers in Virginia: A Factorial Design of Effectiveness-Implementation Hybrid Research
- ClinicalTrials.gov ID
- NCT03288935
- Acronym / sponsor ID
- HM20011389
- Conditions
- Mental Stress, Emotional Stress
- Keywords
- refugee, trauma-informed case management (TICM), trauma-informed cultural orientation (TICO), PTSD, depression, refugee resettlement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A substantial decrease in refugee arrivals in Virginia didn't allow the investigator to continue the study as planned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (TICM only) | Active comparator | Behavioral: TICMAssigned to TICM group after reception \& placement. |
| Group 2 (TICO only) | Active comparator | Behavioral: TICOAssigned to TICO group after reception \& placement. |
| Group 3 (TICM & TICO) | Active comparator | Behavioral: TICM, Behavioral: TICOAssigned to both TICM and TICO group after reception \& placement. |
| Group 4 (None) | No intervention | –No additional intervention after reception \& placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Refugee adults who arrive in Richmond or Charlottesville between January and February 2018
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TICMThe 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). | Behavioural | Group 1 (TICM only), Group 3 (TICM & TICO) |
| TICOThe 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. | Behavioural | Group 2 (TICO only), Group 3 (TICM & TICO) |
Primary outcome
Change in resettlement distress
Time frame: 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.
3 secondary outcomes
Change in emotional well-being
Time frame: Baseline to 6 months
Resettlement Outcomes
Time frame: Baseline to 6 months
Change in Social Adaptation
Time frame: Baseline to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyojin Im, PhD principal investigator
Virginia Commonwealth Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TICM and TICO in people with Mental Stress and Emotional Stress, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resettlement distress (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.