Stress, PsychologicalNCT03763591
Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds
A study testing Trauma Systems Therapy for Refugees Group Intervention in people with Stress, Psychological and Acculturation Problem, run by Boston Children's Hospital at 1 site in United States.
Trial summary
There are currently 28 million child refugees worldwide - approximately 1 in every 200 children on earth. To date, nearly one million forcibly displaced child migrants have been resettled in the United States. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Stress, Psychological, Acculturation Problem
- What is being tested?
- Trauma Systems Therapy for Refugees Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2019to 9 Feb 2023
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15-18 years old living in the Greater Boston Area.
- Of refugee or immigrant background (e.g., youth or a parent arrived to the USA as a refugee or immigrant)
- No current plans to move from Greater Boston Area within the next 6 months
- Conversationally proficient in English language
Who cannot join
- Not able to attend group once a week for 10 weeks
- Medical, cognitive, or other health or psychosocial issue that would prevent consistent and engagement and participation in group.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02215
About this study
There are currently 28 million child refugees worldwide - approximately 1 in every 200 children on earth. To date, nearly one million forcibly displaced child migrants have been resettled in the United States. It is well documented that refugee and immigrant youth, especially forcibly displaced ethnic and cultural minority youth, present with alarmingly high rates of stress-related psychiatric illness (e.g., PTSD, depression, anxiety) and are grossly underserved by current mental health, medical, and social services. Previous research found that in a sample of 144 Somali refugee children resettled in the United States, only 8% of those who met full clinical criteria for PTSD received any mental health services. Through a process of community-based participatory research with refugee and immigrant communities and stake-holders the investigators have developed a multi-tiered psychological and systems intervention for refugee youth and families, Trauma Systems Therapy for Refugees (TST-R), that includes community outreach and advocacy, group psychological treatment, office-based psychotherapy, and home-based services.
Whereas TST-R is one of the only empirically-based behavioral health treatment models for refugee youth, it has only been studied as a full intervention model; financial and staffing resource barriers have limited the wide-spread adoption of the model. This obstacle noted, implementing one high-impact component of this multi-tier intervention (i.e., protocol-driven group treatments) may provide significant benefit while also being easily scalable. Implementing time-limited (i.e., 10 week) manual-based group psychological interventions focused on culturally-responsive strategies to support refugee youth with, and at-risk for, PTSD, depression, and anxiety, may be an efficient and cost effective means of (1) reducing psychiatric symptoms for refugee and migrant youth with present symptoms, (2) preventing symptom onset for those at risk, and (3) enhancing cultural identity self-concept, subjective social belongingness, and psychological resilience (e.g., ability to thrive in the context of adversity). Furthermore, if effective, treatment groups can importantly function as a destigmatizing treatment gateway and triage to other services for youth who require a higher level of care (e.g., individual psychotherapy and medication management).
- Conditions
- Stress, Psychological, Acculturation Problem
- Being tested
- Trauma Systems Therapy for Refugees Group Intervention
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Systems Therapy for Refugees Group InterventionBehavioural
Psychological skills group for youth of refugee and immigrant backgrounds.
| Study group | Role | What they receive |
|---|---|---|
| Psychological Skills Group (e.g., Active Intervention) | Experimental | 10-week Psychological Skills Group. Receives: Behavioral: Trauma Systems Therapy for Refugees Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Symptoms
Depression as measured by the Patient Health Questionnaire-9 (PHQ-9). Self-report depression scale, higher scores mean greater symptoms of depression (e.g., worse outcome). Total score sum may range from 0 to 27.
Measured: Change from Baseline after 10 weeks of the intervention.
Anxiety Symptoms
Anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7). Self-report anxiety scale, higher scores mean greater symptoms of anxiety (e.g., worse outcome). Total score sum may range from 0 to 21.
Measured: Change from Baseline after 10 weeks of the intervention.
Post Traumatic Stress Disorder (PTSD) Symptoms
PTSD as measured by the STRESS (Structured Trauma-Related Experiences and Symptoms Screener). Self-report PTSD scale, higher scores mean greater symptoms of PTSD (e.g., worse outcome). Total score sum may range from 0 to 68.
Measured: Change from Baseline after 10 weeks of the intervention.
Cultural Identity Self-Concept
Cultural Identity Self-Concept measured with social and cultural identities adapted version of Cognitive Fusion Questionnaire (CFQ). Self-report measure. Higher scores indicate greater cognitive and emotional suffering related to social and cultural identity self-concept (example item: "my thoughts about my social and cultural identities cause me distress or emotional pain." Total score sum may range from 0 to 42. Higher scores indicate worse outcome.
Measured: Change from Baseline after 10 weeks of intervention.
Self-Efficacy
Self-Efficacy measured by New General Self-Efficacy Scale (NGSES). Self-report measure. Higher scores indicate greater perceived ability to accomplish goals and overcome challenges (example item: "I will be able to achieve most of the goals that I have set for myself.") Total score sum may range from 0 to 48. Higher scores indicate better outcome.
Measured: Change from Baseline after 10 weeks of intervention.
Social Belongingness
Social Belongingness as measured by the General Belongingness Scale (GBS). Self-report measure. Higher scores indicate greater sense of social belongingness (example item: "I feel connected with others.") Total score sum may range from 0 to 72. Higher scores indicate better outcome.
Measured: Change from Baseline after 10 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start28 Mar 2019
- Primary completion1 Nov 2022
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Winer, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763591
- Sponsor's protocol ID
- IRB-P00029550
- Status last verified
- Feb 2023
- First submitted
- 28 Nov 2018
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ellis BH, Miller AB, Abdi S, Barrett C, Blood EA, Betancourt TS. Multi-tier mental health program for refugee youth. J Consult Clin Psychol. 2013 Feb;81(1):129-40. doi: 10.1037/a0029844. Epub 2012 Aug 27.
PubMed 22924331Ellis BH, MacDonald HZ, Lincoln AK, Cabral HJ. Mental health of Somali adolescent refugees: the role of trauma, stress, and perceived discrimination. J Consult Clin Psychol. 2008 Apr;76(2):184-93. doi: 10.1037/0022-006X.76.2.184.
PubMed 18377116Bogic M, Njoku A, Priebe S. Long-term mental health of war-refugees: a systematic literature review. BMC Int Health Hum Rights. 2015 Oct 28;15:29. doi: 10.1186/s12914-015-0064-9.
PubMed 26510473Grasso DJ, Felton JW, Reid-Quinones K. The Structured Trauma-Related Experiences and Symptoms Screener (STRESS): Development and Preliminary Psychometrics. Child Maltreat. 2015 Aug;20(3):214-20. doi: 10.1177/1077559515588131. Epub 2015 Jun 19.
PubMed 26092442Lustig SL, Kia-Keating M, Knight WG, Geltman P, Ellis H, Kinzie JD, Keane T, Saxe GN. Review of child and adolescent refugee mental health. J Am Acad Child Adolesc Psychiatry. 2004 Jan;43(1):24-36. doi: 10.1097/00004583-200401000-00012.
PubMed 14691358Alegria M, Vallas M, Pumariega AJ. Racial and ethnic disparities in pediatric mental health. Child Adolesc Psychiatr Clin N Am. 2010 Oct;19(4):759-74. doi: 10.1016/j.chc.2010.07.001.
PubMed 21056345Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
PubMed 10568646Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
PubMed 24411117Malone, G. P., Pillow, D. R., Osman, A. (2012). The General Belongingness Scale (GBS): Assessing achieved belongingness. Personality and Individual Differences, 52(3), 311-316.
Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a New General Self-Efficacy Scale. Organizational Research Methods, 4(1), 62-83.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds
- ClinicalTrials.gov ID
- NCT03763591
- Acronym / sponsor ID
- IRB-P00029550
- Conditions
- Stress, Psychological, Acculturation Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 4 Dec 2018 (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.
There are currently 28 million child refugees worldwide - approximately 1 in every 200 children on earth. To date, nearly one million forcibly displaced child migrants have been resettled in the United States. It is well documented that refugee and immigrant youth, especially forcibly displaced ethnic and cultural minority youth, present with alarmingly high rates of stress-related psychiatric illness (e.g., PTSD, depression, anxiety) and are grossly underserved by current mental health, medical, and social services. Previous research found that in a sample of 144 Somali refugee children resettled in the United States, only 8% of those who met full clinical criteria for PTSD received any mental health services. Through a process of community-based participatory research with refugee and immigrant communities and stake-holders the investigators have developed a multi-tiered psychological and systems intervention for refugee youth and families, Trauma Systems Therapy for Refugees (TST-R), that includes community outreach and advocacy, group psychological treatment, office-based psychotherapy, and home-based services.
Whereas TST-R is one of the only empirically-based behavioral health treatment models for refugee youth, it has only been studied as a full intervention model; financial and staffing resource barriers have limited the wide-spread adoption of the model. This obstacle noted, implementing one high-impact component of this multi-tier intervention (i.e., protocol-driven group treatments) may provide significant benefit while also being easily scalable. Implementing time-limited (i.e., 10 week) manual-based group psychological interventions focused on culturally-responsive strategies to support refugee youth with, and at-risk for, PTSD, depression, and anxiety, may be an efficient and cost effective means of (1) reducing psychiatric symptoms for refugee and migrant youth with present symptoms, (2) preventing symptom onset for those at risk, and (3) enhancing cultural identity self-concept, subjective social belongingness, and psychological resilience (e.g., ability to thrive in the context of adversity). Furthermore, if effective, treatment groups can importantly function as a destigmatizing treatment gateway and triage to other services for youth who require a higher level of care (e.g., individual psychotherapy and medication management).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological Skills Group (e.g., Active Intervention) | Experimental | Behavioral: Trauma Systems Therapy for Refugees Group Intervention10-week Psychological Skills Group. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 15-18 years old living in the Greater Boston Area.
- Of refugee or immigrant background (e.g., youth or a parent arrived to the USA as a refugee or immigrant)
- No current plans to move from Greater Boston Area within the next 6 months
- Conversationally proficient in English language
Key exclusion criteria (2 listed)
- Not able to attend group once a week for 10 weeks
- Medical, cognitive, or other health or psychosocial issue that would prevent consistent and engagement and participation in group.
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 |
|---|---|---|
| Trauma Systems Therapy for Refugees Group InterventionPsychological skills group for youth of refugee and immigrant backgrounds. | Behavioural | Psychological Skills Group (e.g., Active Intervention) |
Primary outcome
Depression Symptoms
Time frame: Change from Baseline after 10 weeks of the intervention.
Depression as measured by the Patient Health Questionnaire-9 (PHQ-9). Self-report depression scale, higher scores mean greater symptoms of depression (e.g., worse outcome). Total score sum may range from 0 to 27.
Anxiety Symptoms
Time frame: Change from Baseline after 10 weeks of the intervention.
Anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7). Self-report anxiety scale, higher scores mean greater symptoms of anxiety (e.g., worse outcome). Total score sum may range from 0 to 21.
Post Traumatic Stress Disorder (PTSD) Symptoms
Time frame: Change from Baseline after 10 weeks of the intervention.
PTSD as measured by the STRESS (Structured Trauma-Related Experiences and Symptoms Screener). Self-report PTSD scale, higher scores mean greater symptoms of PTSD (e.g., worse outcome). Total score sum may range from 0 to 68.
Cultural Identity Self-Concept
Time frame: Change from Baseline after 10 weeks of intervention.
Cultural Identity Self-Concept measured with social and cultural identities adapted version of Cognitive Fusion Questionnaire (CFQ). Self-report measure. Higher scores indicate greater cognitive and emotional suffering related to social and cultural identity self-concept (example item: "my thoughts about my social and cultural identities cause me distress or emotional pain." Total score sum may range from 0 to 42. Higher scores indicate worse outcome.
Self-Efficacy
Time frame: Change from Baseline after 10 weeks of intervention.
Self-Efficacy measured by New General Self-Efficacy Scale (NGSES). Self-report measure. Higher scores indicate greater perceived ability to accomplish goals and overcome challenges (example item: "I will be able to achieve most of the goals that I have set for myself.") Total score sum may range from 0 to 48. Higher scores indicate better outcome.
Social Belongingness
Time frame: Change from Baseline after 10 weeks of intervention.
Social Belongingness as measured by the General Belongingness Scale (GBS). Self-report measure. Higher scores indicate greater sense of social belongingness (example item: "I feel connected with others.") Total score sum may range from 0 to 72. Higher scores indicate better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Background: PubMed 22924331Ellis BH, Miller AB, Abdi S, Barrett C, Blood EA, Betancourt TS. Multi-tier mental health program for refugee youth. J Consult Clin Psychol. 2013 Feb;81(1):129-40. doi: 10.1037/a0029844. Epub 2012 Aug 27.
- Background: PubMed 18377116Ellis BH, MacDonald HZ, Lincoln AK, Cabral HJ. Mental health of Somali adolescent refugees: the role of trauma, stress, and perceived discrimination. J Consult Clin Psychol. 2008 Apr;76(2):184-93. doi: 10.1037/0022-006X.76.2.184.
- Background: PubMed 26510473Bogic M, Njoku A, Priebe S. Long-term mental health of war-refugees: a systematic literature review. BMC Int Health Hum Rights. 2015 Oct 28;15:29. doi: 10.1186/s12914-015-0064-9.
- Background: PubMed 26092442Grasso DJ, Felton JW, Reid-Quinones K. The Structured Trauma-Related Experiences and Symptoms Screener (STRESS): Development and Preliminary Psychometrics. Child Maltreat. 2015 Aug;20(3):214-20. doi: 10.1177/1077559515588131. Epub 2015 Jun 19.
- Background: PubMed 14691358Lustig SL, Kia-Keating M, Knight WG, Geltman P, Ellis H, Kinzie JD, Keane T, Saxe GN. Review of child and adolescent refugee mental health. J Am Acad Child Adolesc Psychiatry. 2004 Jan;43(1):24-36. doi: 10.1097/00004583-200401000-00012.
- Background: PubMed 21056345Alegria M, Vallas M, Pumariega AJ. Racial and ethnic disparities in pediatric mental health. Child Adolesc Psychiatr Clin N Am. 2010 Oct;19(4):759-74. doi: 10.1016/j.chc.2010.07.001.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 10568646Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Background: PubMed 24411117Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
- BackgroundMalone, G. P., Pillow, D. R., Osman, A. (2012). The General Belongingness Scale (GBS): Assessing achieved belongingness. Personality and Individual Differences, 52(3), 311-316.
- BackgroundChen, G., Gully, S. M., & Eden, D. (2001). Validation of a New General Self-Efficacy Scale. Organizational Research Methods, 4(1), 62-83.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Systems Therapy for Refugees Group Intervention in people with Stress, Psychological and Acculturation Problem, run by Boston Children's Hospital 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 23 Feb 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression Symptoms (time frame: Change from Baseline after 10 weeks of the intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03763591, which also lists 11 linked publications.
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 23 Feb 2023.