Clinical trial NCT04931888: 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
Overall status: COMPLETED
Phase: NA
Conditions: Social Emotional Wellness
Keywords: Refugee Children
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Academic Pediatric Association
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-06-18
Enrollment: 31
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change in Social Emotional Competence
timeFrame: Baseline to 4 Weeks
measure: Change in COVID-19 Knowledge
timeFrame: Baseline to 4 Weeks
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline to 4 Weeks
measure: Parent Afghan Symptom Checklist
timeFrame: Only asked of parents. To save time and build trust, this exploratory measure was not asked on follow-up because of participant burden for questions.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Julia Rosenberg, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: