Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds
Primary Purpose
Stress, Psychological, Acculturation Problem
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma Systems Therapy for Refugees Group Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Stress, Psychological
Eligibility Criteria
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.
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psychological Skills Group (e.g., Active Intervention)
Arm Description
10-week Psychological Skills Group.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03763591
First Posted
November 28, 2018
Last Updated
February 22, 2023
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03763591
Brief Title
Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds
Official Title
Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
February 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Acculturation Problem
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychological Skills Group (e.g., Active Intervention)
Arm Type
Experimental
Arm Description
10-week Psychological Skills Group.
Intervention Type
Behavioral
Intervention Name(s)
Trauma Systems Therapy for Refugees Group Intervention
Intervention Description
Psychological skills group for youth of refugee and immigrant backgrounds.
Primary Outcome Measure Information:
Title
Depression Symptoms
Description
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.
Time Frame
Change from Baseline after 10 weeks of the intervention.
Title
Anxiety Symptoms
Description
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.
Time Frame
Change from Baseline after 10 weeks of the intervention.
Title
Post Traumatic Stress Disorder (PTSD) Symptoms
Description
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.
Time Frame
Change from Baseline after 10 weeks of the intervention.
Title
Cultural Identity Self-Concept
Description
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.
Time Frame
Change from Baseline after 10 weeks of intervention.
Title
Self-Efficacy
Description
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.
Time Frame
Change from Baseline after 10 weeks of intervention.
Title
Social Belongingness
Description
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.
Time Frame
Change from Baseline after 10 weeks of intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22924331
Citation
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.
Results Reference
background
PubMed Identifier
18377116
Citation
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.
Results Reference
background
PubMed Identifier
26510473
Citation
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.
Results Reference
background
PubMed Identifier
26092442
Citation
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.
Results Reference
background
PubMed Identifier
14691358
Citation
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.
Results Reference
background
PubMed Identifier
21056345
Citation
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.
Results Reference
background
PubMed Identifier
16717171
Citation
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.
Results Reference
background
PubMed Identifier
10568646
Citation
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.
Results Reference
background
PubMed Identifier
24411117
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a New General Self-Efficacy Scale. Organizational Research Methods, 4(1), 62-83.
Results Reference
background
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Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds
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