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Trial record 2 of 554 for:    Recruiting, Not yet recruiting Studies | Psychiatric Problem

Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds

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ClinicalTrials.gov Identifier: NCT03763591
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Winer, Boston Children’s Hospital

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).


Condition or disease Intervention/treatment Phase
Stress, Psychological Acculturation Problem Behavioral: Trauma Systems Therapy for Refugees Group Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Psychological Skills Group (e.g., Active Intervention)
10-week Psychological Skills Group.
Behavioral: Trauma Systems Therapy for Refugees Group Intervention
Psychological skills group for youth of refugee and immigrant backgrounds.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763591


Contacts
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Contact: Jeffrey P Winer, PhD 617-919-4678 jeffrey.winer@childrens.harvard.edu
Contact: Osob Issa, MSW 617-919-4623 osob.issa@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jeffrey P Winer, PhD         
Sponsors and Collaborators
Boston Children’s Hospital

Publications:
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.

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Responsible Party: Jeffrey Winer, Research Fellow, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03763591    
Other Study ID Numbers: IRB-P00029550
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms