Social Emotional WellnessNCT04931888
Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic
A study testing EMPOWER in people with Social Emotional Wellness, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Emotional Wellness
- What is being tested?
- EMPOWER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2022to 20 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- at least 1 year of schooling in the United States
- must speak: Pashto, Dari or English
- connected with the community organization: Elena's Light
Who cannot join
- inability to meet any of the requirements of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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).
- Conditions
- Social Emotional Wellness
- Being tested
- EMPOWER
- Keywords
- Refugee Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWERBehavioural
Also called Emotions Program Outside the Clinic and Wellness Education for Refugees
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations. Receives: 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. Receives: Behavioral: EMPOWER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: Baseline to 4 Weeks
Secondary outcomes (2)
Change in Quality of Life
Scored subscales of: emotional, social, and school functioning. Ten total questions, each scored on a 0-4 Likert scale. Scores transformed to a 0-100 scale, with higher scores indicating a higher quality of life score.
Measured: Baseline to 4 Weeks
Parent Afghan Symptom Checklist
The Afhgan symptom checklist is a culturally-informed measure to evaluate distress and functioning in individuals from Afghanistan. We administered 21 of 22 questions to parents. Each question was scored on a scale of 1 to 5 (so minimum score (least distress) could be 21, and maximum score (most distressed) could be 105.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start20 May 2022
- Primary completion15 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Emotional WellnessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Pediatric Association, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Julia Rosenberg, MD MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931888
- Sponsor's protocol ID
- 2000030455
- Other IDs
- KL2TR001862
- Status last verified
- Nov 2023
- First submitted
- 11 Jun 2021
- Last updated
- 30 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40783623
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04931888
- Acronym / sponsor ID
- 2000030455
- Conditions
- Social Emotional Wellness
- Keywords
- Refugee Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Academic Pediatric Association, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 20 May 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 30 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: EMPOWERThe intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations. |
| Waitlist | Other | Behavioral: EMPOWERThe 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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- at least 1 year of schooling in the United States
- must speak: Pashto, Dari or English
- connected with the community organization: Elena's Light
Key exclusion criteria (1 listed)
- inability to meet any of the requirements of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPOWERAlso: Emotions Program Outside the Clinic and Wellness Education for RefugeesEMPOWER 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. | Behavioural | Intervention, Waitlist |
Primary outcome
Change in Social Emotional Competence
Time frame: Baseline to 4 Weeks
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)
Change in COVID-19 Knowledge
Time frame: Baseline to 4 Weeks
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).
2 secondary outcomes
Change in Quality of Life
Time frame: Baseline to 4 Weeks
Parent Afghan Symptom Checklist
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40783623Rosenberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Rosenberg, MD MHS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER in people with Social Emotional Wellness, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Emotional Competence (time frame: Baseline to 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04931888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.