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Community Mental Health ServicesEASENCT06934954

Early Adolescent Skills for Emotions

A study testing EASE in people with Community Mental Health Services, run by The New School at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 10 years and olderHealthy volunteers can take part
Conditions the study is for
Community Mental Health Services
What is being tested?
EASE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
17 Mar 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 10 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Adolescents
  • 10-15 years old
  • English-speaking
  • Has obtained parental permission from a legally authorized representative (e.g. legal guardian).
  • ○ 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.

Who cannot join

  • The program is not intended for adolescents and caregivers who are experiencing severe cognitive impairments and/or have an imminent risk of suicide/acute protection needs.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tina Xu, MA contact

2122295150

xut360@newschool.edu

Adam Brown, PhD contact

2122295150

brownad@newschool.edu

United States1 site, 1 recruiting

  • The New School Center for Global Mental Health

    New York, New York, 10011

    Josheka Chauhan, MA, 212-229-5150, josheka@newschool.edu

    Tina Xu, MA, 2122295150, xut360@newschool.edu

    Recruiting

Other trials in United States

About this study

Official title: Adapted Early Adolescent Skills for Emotions (EASE) to Decrease Psychological Distress Among Urban Youth and Caregivers in NYC: a Pilot Study

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:

Read more
  • Assess the acceptability and feasibility of training and supervision of EASE Helpers (community staff members) through an adapted EASE training.
  • Evaluate possible problems of recruitment, intervention delivery, and participant retention.
  • Assess the feasibility of EASE being delivered via a partnership between researchers and community members.
  • Evaluate implementation of EASE via the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework

A mixed-methods design with qualitative and quantitative approaches will be used to assess these objectives.

Read the detailed description

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.

Being tested
EASE
Keywords
Youth Mental Health, Adolescent Mental Health, Community Mental Health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EASEBehavioural

    This is the first time EASE is being used in New York to support youth community mental health.

Study groups in NCT06934954
Study groupRoleWhat they receive
EASE InterventionExperimentalEASE 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.
Receives: Behavioral: EASE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

    Measured: 8 months

Secondary outcomes (9)

  1. 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".

    Measured: 8 months

  2. 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".

    Measured: 8 months

  3. 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".

    Measured: 8 months

  4. 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.

    Measured: 8 months

  5. 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.

    Measured: 8 months

  6. 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".

    Measured: 8 months

  7. 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".

    Measured: 8 months

  8. 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".

    Measured: 8 months

  9. 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".

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start17 Mar 2025
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06934954
Sponsor's protocol ID
EASE
Other IDs
000001
Acronym
EASE
Status last verified
Apr 2025
First submitted
27 Mar 2025
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36858980

  • 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.

    PubMed 34339320

  • 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.

    PubMed 35301042

  • 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.

    PubMed 30600639

  • 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.

    PubMed 21056345

  • 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.

    PubMed 36177440

  • 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.

    PubMed 33763401

  • 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.

    PubMed 37748283

  • 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.

    PubMed 35960704

  • 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;12(1):102. doi: 10.1186/s40814-026-01840-8.

    PubMed 42210344

Questions about this trial

What is this clinical trial studying?

A study testing EASE in people with Community Mental Health Services, run by The New School 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 8 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: looking for participants now, as of the sponsor's last update on 18 Apr 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tina Xu, MA (2122295150, xut360@newschool.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pediatric Symptom Checklist Youth Report (Y-PSC) (time frame: 8 months). 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 NCT06934954, which also lists 10 linked publications.

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 18 Apr 2025.

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