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| ID | Type | Description | Link |
|---|---|---|---|
| 000001 | Other Grant/Funding Number | New York City Mayors Office Community Mental Health |
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The EASE program is an existing, evidence-based program/intervention (originally developed by the WHO), and this study is limited to evaluating the local implementation of this program.
The aims of this pilot study are to:
A mixed-methods design with qualitative and quantitative approaches will be used to assess these objectives.
Despite the growing need for adolescent mental health services in the US, access to treatment has remained especially inequitable for ethnic minorities. Studies have identified socio-ecological barriers, such as stigma, caregiver attitudes, and income, that contribute to a number of disparities between ethnically minoritized adolescents and their white counterparts. Although there is support for evidence-based psychotherapies in improving youth mental health outcomes generally, the mental health burden and structural inequities faced by ethnically minoritized adolescents call for novel approaches that may address some of the challenges and bridge the services and treatment gap.
One approach that is becoming increasingly studied globally is task-sharing mental health interventions. Task-sharing often refers to brief and non-specialist-delivered versions of evidence-based psychological treatments for people with mildly to moderately severe mental health symptoms, especially in under resourced settings and low- and middle-income countries (LMICs). Randomized controlled trials (RCTs) have indicated that scalable mental health interventions are effective in reducing symptoms of distress and post-traumatic symptomatology across different populations and contexts at follow-up assessments.
Although there is now considerable work evaluating the potential benefits of task-sharing interventions globally, this approach is somewhat newer in the US. However, burgeoning work in the US is beginning to show the feasibility of such intervention with adults. The New School Center for Global Mental Health has also conducted adaptations, training, and program evaluations for task-sharing interventions like the World Health Organization's (WHO) Problem Management Plus (PM+) for adult community members in NYC since 2020. Initial evaluations have indicated the acceptability, feasibility, and utility of PM+ in the NYC context. Given the evidence-based support for task-sharing interventions for adults and the treatment and services gap for ethnically minoritized adolescents in NYC, the investigators would like to evaluate how well a WHO task-sharing intervention for adolescents - Early Adolescent Skills for Emotions (EASE) - works in community-based organizations in NYC.
EASE targets psychological distress in adolescents ages 10 to 15 years old through seven group sessions with adolescents and three group sessions with the adolescents' caregivers. Each session is 90 minutes, and adolescents learn and engage in strategies that progress in complexity throughout the intervention. Through EASE, adolescents learn how to identify their emotions, distress-related physical arousal, slow breathing as a healthy coping strategy, behavioral activation to engage in meaningful activities, and problem-solving skills. RCTs have indicated the scalability and efficacy of EASE in LMICs like Lebanon and Syria.
To prepare for pilot implementation, researchers from The New School Center for Global Mental Health collected feedback from community partners on EASE in 2024. Based on community recommendations, adaptations to EASE's manual activities/strategies and storybook were made to improve EASE's acceptability, relevance, and accessibility.
The proposed study aims to implement this culturally-adapted version of EASE to urban youth and caregivers in NYC in collaboration with CBOs identified by the NYC Mayor's Office of Community Mental Health (OCMH). Youth/adolescents in this study are defined as children ages 10 to 15 years old. Caregivers in this study are defined as the adults who regularly take care of adolescent(s) 10 to 15 years olds, typically in their home settings. All caregivers that are asked to provide consent for a child's participation in the study will also be the child's legally authorized representative (i.e., parent or legal guardian). The person providing permission for the child to participate in the study must confirm that they are the adolescent's parent or legal guardian. Decisions can be made for adolescents and children by their caregivers if the caregivers are also the adolescents' legally authorized representative. In doing so, the investigators hope to examine the effectiveness, feasibility, acceptability, and utility for implementing EASE in the US and collect additional feedback to improve the adaptation to better bridge the mental health services and treatment gap for urban youth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EASE Intervention | Experimental | EASE targets psychological distress in adolescents ages 10 to 15 years old through seven group sessions with adolescents and three group sessions with the adolescents' caregivers. Each session is 90 minutes, and adolescents learn and engage in strategies that progress in complexity throughout the intervention. Through EASE, adolescents learn how to identify their emotions, distress-related physical arousal, slow breathing as a healthy coping strategy, behavioral activation to engage in meaningful activities, and problem-solving skills. RCTs have indicated the scalability and efficacy of EASE in LMICs like Lebanon and Syria. To prepare for pilot implementation, researchers from The New School Center for Global Mental Health collected feedback from community partners on EASE in 2024. Based on community recommendations, EASE was adapted for the current study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EASE | Behavioral | This is the first time EASE is being used in New York to support youth community mental health. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Symptom Checklist Youth Report (Y-PSC) | For youth participants: The Pediatric Symptom Checklist Youth Report (Y-PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. Participants are to respond to how often they have had certain thoughts, feelings, and experiences listed in the questionnaire in the past 2 weeks with the options "never", "sometimes", and "often". | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire - Adolescent Version (PHQ-A) | For youth participants: The PHQ-A assesses degree of depression severity for adolescents via questionnaire. Participants are to respond to how often they have had certain thoughts and feelings listed in the questionnaire in the past 2 weeks with the options "not at all", "several days", "more than half the days", and "nearly every day". | 8 months |
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Inclusion Criteria:
Adolescents
10-15 years old
English-speaking
Has obtained parental permission from a legally authorized representative (e.g. legal guardian).
â—‹ Caregiver
English-speaking
Is a caretaker of a child ages 10-15 years old, meaning they regularly take care of a child
Adults who are above the age of 18 who meet the above criteria can participate.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tina Xu, MA | Contact | 2122295150 | xut360@newschool.edu | |
| Adam Brown, PhD | Contact | 2122295150 | brownad@newschool.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adam Brown, PhD | The New School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The New School Center for Global Mental Health | Recruiting | New York | New York | 10011 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36858980 | Background | Brown FL, Taha K, Steen F, Kane J, Gillman A, Aoun M, Malik A, Bryant R, Sijbrandij M, El Chammay R, Servili C, van Ommeren M, Akhtar A, Zoghbi E; EASE Intervention Development, Training Team; Jordans MJD; STRENGTHS Consortium. Feasibility randomised controlled trial of the Early Adolescent Skills for Emotions psychological intervention with young adolescents in Lebanon. BMC Psychiatry. 2023 Mar 1;23(1):131. doi: 10.1186/s12888-023-04571-9. | |
| 34339320 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2025 | Apr 10, 2025 | ICF_000.pdf |
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| Warwick Edinburgh Well-being Scale (WEMWBS) | For youth participants: The WEMWBS is a 14-item scale of positively worded statements covering feeling and functioning aspects of mental wellbeing. Participants are to respond to how often they have had certain thoughts and feelings listed in the questionnaire in the past 2 weeks with the options "none of the time", "rarely", "some of the time", "often", and "all of the time". | 8 months |
| Impairment of Daily Function | For youth participants: The Impairment of daily functioning tool evaluates an individual's ability to perform basic and instrumental activities of daily living. Participants are to respond to how difficult it is generally to complete some daily tasks with the options "no difficulty", "little difficulty", "moderate difficulty", "a lot difficulty", and "often can't do task". | 8 months |
| Psychological Sense of School Membership (PSSM) | For youth participants: The Psychological Sense of School Membership is an 18-item tool that measure adolescent students' perceived belonging or psychological membership in the school environment. Participants are to respond to the statements in the questionnaire on a scale. The minimum value of the scale is 1 and the maximum value of the scale is 5. 1 refers to not at all true and 5 refers to completely true. Whether a higher score means a better or worse outcome depends on whether the questionnaire statement needs to be reverse-coded. | 8 months |
| Parental Stress Scale (PSS) | For caregiver participants: The Parental Stress Scale (PSS) is an 18-item questionnaire assessing parents' feelings about their parenting role. Participants are to answer statements on a scale. The minimum value is 1 (strongly disagree) and the maximum value is 5 (strongly agree). Whether a higher score means a better or worse outcome depends on whether the questionnaire statement needs to be reverse-coded. | 8 months |
| Alabama Parenting Questionnaire (APQ) | For caregiver participants: The Alabama Parenting Questionnaire (APQ) is a self-report assessment tool designed to measure five key dimensions of parenting that are related to child behavioral problems. Participants are to respond to how often statements of experiences described in the questionnaire typically occur in their home. The options are "never", "almost never", "sometimes", "often", and "always". | 8 months |
| Patient Health Questionnaire (PHQ-9) | For caregiver participants: The PHQ-9 (Patient Health Questionnaire-9) is a self-report questionnaire used to assess the presence and severity of depressive symptoms. Participants are to respond to how often they have had certain thoughts and feelings listed in the questionnaire in the past 2 weeks with the options "not at all", "several days", "more than half the days", and "nearly every day". | 8 months |
| Generalized Anxiety Disorder Assessment (GAD-7) | For caregiver participants: The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Participants are to respond to how often they have had certain thoughts and feelings listed in the questionnaire in the past 2 weeks with the options "not at all", "several days", "more than half the days", and "nearly every day". | 8 months |
| Kessler's Psychological Distress Scale (K6+) | For caregiver participants: The Kessler Psychological Distress Scale (K6+) is a 6-item self-report measure of psychological distress intended to be used as a quick tool to assess risk for serious mental illness in the general population. Participants are to respond to how often they have had certain thoughts and feelings listed in the questionnaire in the past 30 days with the options "all of the time", "most of the time", "some of the time", "a little of the time", and "none of the time". | 8 months |
| Background |
| Castro-Ramirez F, Al-Suwaidi M, Garcia P, Rankin O, Ricard JR, Nock MK. Racism and Poverty are Barriers to the Treatment of Youth Mental Health Concerns. J Clin Child Adolesc Psychol. 2021 Jul-Aug;50(4):534-546. doi: 10.1080/15374416.2021.1941058. Epub 2021 Aug 2. |
| 35301042 | Background | Fan Q, DuPont-Reyes MJ, Hossain MM, Chen LS, Lueck J, Ma P. Racial and ethnic differences in major depressive episode, severe role impairment, and mental health service utilization in U.S. adolescents. J Affect Disord. 2022 Jun 1;306:190-199. doi: 10.1016/j.jad.2022.03.015. Epub 2022 Mar 14. |
| 30600639 | Background | Dawson KS, Watts S, Carswell K, Shehadeh MH, Jordans MJD, Bryant RA, Miller KE, Malik A, Brown FL, Servili C, van Ommeren M. Improving access to evidence-based interventions for young adolescents: Early Adolescent Skills for Emotions (EASE). World Psychiatry. 2019 Feb;18(1):105-107. doi: 10.1002/wps.20594. No abstract available. |
| 21056345 | Background | Alegria M, Vallas M, Pumariega AJ. Racial and ethnic disparities in pediatric mental health. Child Adolesc Psychiatr Clin N Am. 2010 Oct;19(4):759-74. doi: 10.1016/j.chc.2010.07.001. |
| 36177440 | Background | Weersing VR, Gonzalez A, Hatch B, Lynch FL. Promoting Racial/Ethnic Equity in Psychosocial Treatment Outcomes for Child and Adolescent Anxiety and Depression. Psychiatr Res Clin Pract. 2022 Sep 9;4(3):80-88. doi: 10.1176/appi.prcp.20210044. eCollection 2022 Fall. |
| 33763401 | Background | Lu W, Todhunter-Reid A, Mitsdarffer ML, Munoz-Laboy M, Yoon AS, Xu L. Barriers and Facilitators for Mental Health Service Use Among Racial/Ethnic Minority Adolescents: A Systematic Review of Literature. Front Public Health. 2021 Mar 8;9:641605. doi: 10.3389/fpubh.2021.641605. eCollection 2021. |
| 37748283 | Background | Jordans MJD, Brown FL, Kane J, Taha K, Steen F, Ali R, Elias J, Meksassi B, Aoun M, Greene CM, Malik A, Akhtar A, van Ommeren M, Sijbrandij M, Bryant R; STRENGTHS consortium. Evaluation of the Early Adolescent Skills for Emotions (EASE) intervention in Lebanon: A randomized controlled trial. Compr Psychiatry. 2023 Nov;127:152424. doi: 10.1016/j.comppsych.2023.152424. Epub 2023 Sep 16. |
| 35960704 | Background | Bryant RA, Malik A, Aqel IS, Ghatasheh M, Habashneh R, Dawson KS, Watts S, Jordans MJD, Brown FL, van Ommeren M, Akhtar A. Effectiveness of a brief group behavioural intervention on psychological distress in young adolescent Syrian refugees: A randomised controlled trial. PLoS Med. 2022 Aug 12;19(8):e1004046. doi: 10.1371/journal.pmed.1004046. eCollection 2022 Aug. |
| 42210344 | Derived | Wong J, Xu T, Gonzalez Perez K, Khadduri A, Scott Y, Watkins F, Oswiecimski J, Wang A, Antonaki E, Slachevsky DE, Wong E, Day H, Assoudeh E, Yamin I, Jackson N, Wilkerson M, Manning N, Ascherl W, Murphy S, Flores A, Kohrt BA, Brown AD. Adapted Early Adolescent Skills for Emotions (EASE) to decrease psychological distress among urban adolescents in New York City: a feasibility study protocol for a cluster single arm trial. Pilot Feasibility Stud. 2026 May 29. doi: 10.1186/s40814-026-01840-8. Online ahead of print. |