<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03763591</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00029550</org_study_id>
    <nct_id>NCT03763591</nct_id>
  </id_info>
  <brief_title>Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds</brief_title>
  <official_title>Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are currently 28 million child refugees worldwide - approximately 1 in every 200&#xD;
      children on earth. To date, nearly one million forcibly displaced child migrants have been&#xD;
      resettled in the United States. It is well documented that refugee and immigrant youth,&#xD;
      especially forcibly displaced ethnic and cultural minority youth, present with alarmingly&#xD;
      high rates of stress-related psychiatric illness (e.g., PTSD, depression, anxiety) and are&#xD;
      grossly underserved by current mental health, medical, and social services. Previous research&#xD;
      found that in a sample of 144 Somali refugee children resettled in the United States, only 8%&#xD;
      of those who met full clinical criteria for PTSD received any mental health services. Through&#xD;
      a process of community-based participatory research with refugee and immigrant communities&#xD;
      and stake-holders the investigators have developed a multi-tiered psychological and systems&#xD;
      intervention for refugee youth and families, Trauma Systems Therapy for Refugees (TST-R),&#xD;
      that includes community outreach and advocacy, group psychological treatment, office-based&#xD;
      psychotherapy, and home-based services.&#xD;
&#xD;
      Whereas TST-R is one of the only empirically-based behavioral health treatment models for&#xD;
      refugee youth, it has only been studied as a full intervention model; financial and staffing&#xD;
      resource barriers have limited the wide-spread adoption of the model. This obstacle noted,&#xD;
      implementing one high-impact component of this multi-tier intervention (i.e., protocol-driven&#xD;
      group treatments) may provide significant benefit while also being easily scalable.&#xD;
      Implementing time-limited (i.e., 10 week) manual-based group psychological interventions&#xD;
      focused on culturally-responsive strategies to support refugee youth with, and at-risk for,&#xD;
      PTSD, depression, and anxiety, may be an efficient and cost effective means of (1) reducing&#xD;
      psychiatric symptoms for refugee and migrant youth with present symptoms, (2) preventing&#xD;
      symptom onset for those at risk, and (3) enhancing cultural identity self-concept, subjective&#xD;
      social belongingness, and psychological resilience (e.g., ability to thrive in the context of&#xD;
      adversity). Furthermore, if effective, treatment groups can importantly function as a&#xD;
      destigmatizing treatment gateway and triage to other services for youth who require a higher&#xD;
      level of care (e.g., individual psychotherapy and medication management).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Actual">February 9, 2023</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression Symptoms</measure>
    <time_frame>Change from Baseline after 10 weeks of the intervention.</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Symptoms</measure>
    <time_frame>Change from Baseline after 10 weeks of the intervention.</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post Traumatic Stress Disorder (PTSD) Symptoms</measure>
    <time_frame>Change from Baseline after 10 weeks of the intervention.</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cultural Identity Self-Concept</measure>
    <time_frame>Change from Baseline after 10 weeks of intervention.</time_frame>
    <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: &quot;my thoughts about my social and cultural identities cause me distress or emotional pain.&quot; Total score sum may range from 0 to 42. Higher scores indicate worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>Change from Baseline after 10 weeks of intervention.</time_frame>
    <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: &quot;I will be able to achieve most of the goals that I have set for myself.&quot;) Total score sum may range from 0 to 48. Higher scores indicate better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Belongingness</measure>
    <time_frame>Change from Baseline after 10 weeks of intervention.</time_frame>
    <description>Social Belongingness as measured by the General Belongingness Scale (GBS). Self-report measure. Higher scores indicate greater sense of social belongingness (example item: &quot;I feel connected with others.&quot;) Total score sum may range from 0 to 72. Higher scores indicate better outcome.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Acculturation Problem</condition>
  <arm_group>
    <arm_group_label>Psychological Skills Group (e.g., Active Intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10-week Psychological Skills Group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trauma Systems Therapy for Refugees Group Intervention</intervention_name>
    <description>Psychological skills group for youth of refugee and immigrant backgrounds.</description>
    <arm_group_label>Psychological Skills Group (e.g., Active Intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 15-18 years old living in the Greater Boston Area.&#xD;
&#xD;
          -  Of refugee or immigrant background (e.g., youth or a parent arrived to the USA as a&#xD;
             refugee or immigrant)&#xD;
&#xD;
          -  No current plans to move from Greater Boston Area within the next 6 months&#xD;
&#xD;
          -  Conversationally proficient in English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to attend group once a week for 10 weeks&#xD;
&#xD;
          -  Medical, cognitive, or other health or psychosocial issue that would prevent&#xD;
             consistent and engagement and participation in group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>22924331</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18377116</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26510473</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26092442</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>14691358</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21056345</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16717171</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>10568646</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24411117</PMID>
  </reference>
  <reference>
    <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.</citation>
  </reference>
  <reference>
    <citation>Chen, G., Gully, S. M., &amp; Eden, D. (2001). Validation of a New General Self-Efficacy Scale. Organizational Research Methods, 4(1), 62-83.</citation>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Jeffrey Winer</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03763591
org study id: IRB-P00029550
nct id: NCT03763591
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Depression Symptoms
time frame: Change from Baseline after 10 weeks of the intervention.
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.
measure: Anxiety Symptoms
time frame: Change from Baseline after 10 weeks of the intervention.
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.
measure: Post Traumatic Stress Disorder (PTSD) Symptoms
time frame: Change from Baseline after 10 weeks of the intervention.
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.
measure: Cultural Identity Self-Concept
time frame: Change from Baseline after 10 weeks of intervention.
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.
measure: Self-Efficacy
time frame: Change from Baseline after 10 weeks of intervention.
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.
measure: Social Belongingness
time frame: Change from Baseline after 10 weeks of intervention.
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.
arm group label: Psychological Skills Group (e.g., Active Intervention)
arm group type: Experimental
description: 10-week Psychological Skills Group.
intervention type: Behavioral
intervention name: Trauma Systems Therapy for Refugees Group Intervention
description: Psychological skills group for youth of refugee and immigrant backgrounds.
arm group label: Psychological Skills Group (e.g., Active Intervention)
criteria: 
gender: All
minimum age: 15 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
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.
PMID: 22924331
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.
PMID: 18377116
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.
PMID: 26510473
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.
PMID: 26092442
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.
PMID: 14691358
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.
PMID: 21056345
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.
PMID: 16717171
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.
PMID: 10568646
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.
PMID: 24411117
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.
citation: Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a New General Self-Efficacy Scale. Organizational Research Methods, 4(1), 62-83.
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Jeffrey Winer
investigator title: Research Fellow
mesh term: Stress, Psychological
sharing ipd: No