Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic
Primary Purpose
Social Emotional Wellness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMPOWER
Sponsored by
About this trial
This is an interventional prevention trial for Social Emotional Wellness focused on measuring Refugee Children
Eligibility Criteria
Inclusion Criteria:
- at least 1 year of schooling in the United States
- must speak: Pashto, Dari or English
- connected with the community organization: Elena's Light
Exclusion Criteria:
- inability to meet any of the requirements of the inclusion criteria
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Waitlist
Arm Description
The intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations.
The waitlist control arm will receive the EMPOWER curriculum after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
Outcomes
Primary Outcome Measures
Change in Social Emotional Competence
Using the Trait Meta Mood Scale - Evaluation of Attention to Feelings Score using a 7-question tool, each with a five-point Likert scale for possible responses. Score range: 0 (lowest attention to feelings) to 28 (highest attention too feelings).
Change in COVID-19 Knowledge
Using previously-validated COVID-19 knowledge instrument -- Using five yes-no questions and three questions with free-text response elements. Score range: 0% correct to 100% correct (increments of 20%).
Secondary Outcome Measures
Change in Quality of Life
Using the PEDS-QL scale (3 versions with similar questions: one for 13-18 year olds, one for 8-12 year olds, and one which we will use for children <8). Each with a total of ten questions with a five-point Likert scale for older children and a 3-point Likert scale for children <8. For children 9 and older, the score range is 40 (lowest quality of life) to 40 (highest quality of life). For children under age 8, the score range is 20 (lowest quality of life) to 0 (highest quality of life).
Change in Stress
Using the Perceived Stress Scale - 10 questions, each with a five-point Likert scale, with score ranges of 0 (lowest perceived stress) to 40 (highest perceived stress).
Full Information
NCT ID
NCT04931888
First Posted
June 11, 2021
Last Updated
August 26, 2022
Sponsor
Yale University
Collaborators
Academic Pediatric Association, National Center for Advancing Translational Science
1. Study Identification
Unique Protocol Identification Number
NCT04931888
Brief Title
Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic
Official Title
Implementing and Evaluating a Wellness and Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic: EMPOWER (Emotions Program Outside the Clinic and Wellness Education for Refugees)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Academic Pediatric Association, National Center for Advancing Translational Science
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
The overall goal of this overall goal is to pilot an adaptation of an established Social-Emotional Learning Program with novel wellness and COVID-19 safety components that are trauma-informed and culturally-specific in a resettled refugee community. In this pilot, "EMPOWER" (Emotions Program Outside the clinic and Wellness Education for Refugees), the study team will assess implementation outcomes (adoption, acceptability, and feasibility) of EMPOWER with refugee children and families during the COVID-19 pandemic through longitudinal evaluations and measurements of feasibility, acceptability, and attrition. The study team will also evaluate the impact of EMPOWER by assessing (a) children's social-emotional learning competence and (b) children's and family's COVID-19 knowledge.
Detailed Description
The major question that guides this research is: can an adaptation of an established Social-Emotional Learning (SEL) curriculum effectively improve Social-Emotional wellness for refugee children and their families? The hypothesis is that participation in this program will (a) improve children's SEL competence and (b) lessen stress and improve quality of life for refugee families.
The overall objective of this study is to establish and evaluate the preliminary efficacy and implementation of an adapted social-emotional learning (SEL) and Wellness Program for refugees: EMPOWER (Emotions Program Outside the clinic with Wellness Education for Refugees). To achieve the two aims of this study, the study team will conduct a wait-list controlled pilot to establish and evaluate the preliminary efficacy of participation in EMPOWER by assessing (a) children's SEL competence and (b) measures of mental health, stress, quality of life and wellness before and after participation in the program (Aim 1). Then, the study team will assess the implementation of EMPOWER with refugee children by using mixed methods to perform a summative evaluation of implementation outcomes-including fidelity, sustainability, and reach-in the Afghan refugee community (Aim 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Emotional Wellness
Keywords
Refugee Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations.
Arm Title
Waitlist
Arm Type
Other
Arm Description
The waitlist control arm will receive the EMPOWER curriculum after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
Intervention Type
Behavioral
Intervention Name(s)
EMPOWER
Other Intervention Name(s)
Emotions Program Outside the Clinic and Wellness Education for Refugees
Intervention Description
EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
Primary Outcome Measure Information:
Title
Change in Social Emotional Competence
Description
Using the Trait Meta Mood Scale - Evaluation of Attention to Feelings Score using a 7-question tool, each with a five-point Likert scale for possible responses. Score range: 0 (lowest attention to feelings) to 28 (highest attention too feelings).
Time Frame
Baseline to 2 Weeks
Title
Change in COVID-19 Knowledge
Description
Using previously-validated COVID-19 knowledge instrument -- Using five yes-no questions and three questions with free-text response elements. Score range: 0% correct to 100% correct (increments of 20%).
Time Frame
Baseline to 2 Weeks
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
Using the PEDS-QL scale (3 versions with similar questions: one for 13-18 year olds, one for 8-12 year olds, and one which we will use for children <8). Each with a total of ten questions with a five-point Likert scale for older children and a 3-point Likert scale for children <8. For children 9 and older, the score range is 40 (lowest quality of life) to 40 (highest quality of life). For children under age 8, the score range is 20 (lowest quality of life) to 0 (highest quality of life).
Time Frame
Baseline to 2 Weeks
Title
Change in Stress
Description
Using the Perceived Stress Scale - 10 questions, each with a five-point Likert scale, with score ranges of 0 (lowest perceived stress) to 40 (highest perceived stress).
Time Frame
Baseline to 2 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
at least 1 year of schooling in the United States
must speak: Pashto, Dari or English
connected with the community organization: Elena's Light
Exclusion Criteria:
inability to meet any of the requirements of the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Rosenberg, MD MHS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic
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