- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03763591
Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Boston Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychological Skills Group (e.g., Active Intervention)
10-week Psychological Skills Group.
|
Psychological skills group for youth of refugee and immigrant backgrounds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from Baseline after 10 weeks of the intervention.
|
|
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.
|
Change from Baseline after 10 weeks of the intervention.
|
|
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.
|
Change from Baseline after 10 weeks of the intervention.
|
|
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.
|
Change from Baseline after 10 weeks of intervention.
|
|
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.
|
Change from Baseline after 10 weeks of intervention.
|
|
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.
|
Change from Baseline after 10 weeks of intervention.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Spitzer 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.
- 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.
- Ellis 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.
- Bogic 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.
- Grasso 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.
- Lustig 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.
- Alegria 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.
- Spitzer 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.
- Gillanders 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.
- Malone, 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00029550
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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