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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR001862 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Academic Pediatric Association | INDUSTRY |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 4 Weeks |
| Parent Afghan Symptom Checklist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Rosenberg, MD MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40783623 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention - Child | The child respondents for the intervention group. The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations. EMPOWER: 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. |
| FG001 | Intervention - Parent | The parent respondents for the intervention group. The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations. EMPOWER: 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. |
| FG002 | Waitlist - Child | The child respondents for the waitlist group. The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm. EMPOWER: 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. |
| FG003 | Waitlist - Parent | The parent respondents for the waitlist group. The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm. EMPOWER: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants include parents and children (3 of intervention and 3 of waitlist control are parents). The intervention group included 3 families. The waitlist control group also included 3 families.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention - Child | The Child respondents for the intervention group. The intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations. EMPOWER: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Children were excluded if they or their parents were unsure how to answer. The question was only asked of and/or about child participants (not parents) | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 4 Weeks |
|
Two months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention - Child | The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations. EMPOWER: 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Rosenberg, MD MHS | Yale University | 2037777411 | julia.rosenberg@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2022 | Jul 23, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 20, 2022 | Jul 23, 2023 | ICF_001.pdf |
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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. |
| 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. |
| BG001 | Intervention - Parent | The Parent respondents for the intervention group. The intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations. EMPOWER: 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. |
| BG002 | Waitlist - Child | The Child respondents for the intervention group. 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. EMPOWER: 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. |
| BG003 | Waitlist - Parents | The Parent respondents for the intervention group. 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. EMPOWER: 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. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary Language | Count of Participants | Participants |
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| Covid Knowledge Score | 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. | Young children unable to answer questions were excluded | Mean | Standard Deviation | units on a scale |
|
| Trait Meta Mood Scale | 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) | Participants who were parents were excluded, as responses reflected children's scores. Some responses were proxy responses (parent completed on behalf of child) and some were by children. If a parent expressed the child was too young to answer or have displayed answers to these questions, they did not complete the questions. | Mean | Standard Deviation | units on a scale |
|
| Pediatric Quality of Life Score | 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. | Responses are only for child respondents, some with proxy respondents and some with child respondents. | Mean | Standard Deviation | units on a scale |
|
| Parent Afghan Symptom Checklist Score | 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. | Only asked of parents. To save time and build trust, this exploratory measure was not asked on follow-up. | Mean | Full Range | units on a scale |
|
| OG001 | Intervention Parent | The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations. EMPOWER: 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. |
| OG002 | Waitlist - Child | The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm. EMPOWER: 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. |
| OG003 | Waitlist - Parent | The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm. EMPOWER: 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. |
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| Primary | 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). | Young children unable to answer questions were excluded | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 4 Weeks |
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| Secondary | 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. | Questions were only asked to or about children, not parents | Posted | Median | 95% Confidence Interval | score on a scale | Baseline to 4 Weeks |
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| Secondary | 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. | 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. | Posted | 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. |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Intervention - Parent | The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations. EMPOWER: 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Waitlist - Child | The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm. EMPOWER: 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Waitlist - Parent | The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm. EMPOWER: 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| Male |
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| Dari |
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