Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic

NCT04931888 | Completed Results

• 2 other identifiers: 2000030455KL2TR001862
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Emotional Wellness

Keywords

Refugee Children

Outcome Measures

Primary Outcomes (2)

• Change in Social Emotional Competence

  Subscale from Trait Meta Mood Scale: Attention to Feelings Score, Maximum 35 (7 questions on a 1-5 Likert scale, with 35 being the highest score and 7 being the lowest score)

  Baseline to 4 Weeks

• Change in COVID-19 Knowledge

  Number Correct out of 5 (yes/no) COVID-19 Knowledge Questions. Score range 0-5, with 0 being the lowest score (incorrect for all questions), and 5 being the highest score (correct for all questions).

  Baseline to 4 Weeks

Secondary Outcomes (2)

• Change in Quality of Life

  Baseline to 4 Weeks

• Parent Afghan Symptom Checklist

  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.

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations.

Behavioral: EMPOWER

Waitlist

OTHER

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.

Behavioral: EMPOWER

Interventions

EMPOWER BEHAVIORAL

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.

Also known as: Emotions Program Outside the Clinic and Wellness Education for Refugees

Intervention; Waitlist

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• at least 1 year of schooling in the United States
• must speak: Pashto, Dari or English
• connected with the community organization: Elena's Light

Sponsors & Collaborators

• Yale University: lead
• Academic Pediatric Association: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Rosenberg J, McDonough Ryan P, Schaffer R, O'Brien C, Shabanova V, Ganjavi F, Sharifi M. Wait-List Controlled Pilot Trial of a Preventive Mental Health Intervention for Refugee Youth. J Immigr Minor Health. 2025 Oct;27(5):723-733. doi: 10.1007/s10903-025-01739-1. Epub 2025 Aug 9.

  PMID: 40783623 DERIVED

Limitations and Caveats

Limitations included a smaller than expected sample size because of concurrent summer school opportunities. We also did not evaluate parental stress after participation because of this small sample size and question burden. Our translated instruments (Trait Meta Mood Scale, Peds-QL, COVID-19 questions) are early versions of translations, and will require formal validation in future studies.

Results Point of Contact

• Title: Julia Rosenberg, MD MHS
• Organization: Yale University

julia.rosenberg@yale.edu

2037777411

Study Officials

• Julia Rosenberg, MD MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: May 20, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 20, 2022
• Last Updated: November 30, 2023
• Results First Posted: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)