Early Adolescent Skills for Emotions (EASE)

April 10, 2025 updated by: Adam Brown, Ph.D., The New School

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:

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10011
        • Recruiting
        • The New School Center for Global Mental Health
        • Principal Investigator:
          • Adam Brown, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EASE Intervention
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.
Behavioral: EASE
This is the first time EASE is being used in New York to support youth community mental health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Symptom Checklist Youth Report (Y-PSC)
Time Frame: 8 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire - Adolescent Version (PHQ-A)
Time Frame: 8 months
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
Warwick Edinburgh Well-being Scale (WEMWBS)
Time Frame: 8 months
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
Time Frame: 8 months
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)
Time Frame: 8 months
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)
Time Frame: 8 months
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)
Time Frame: 8 months
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)
Time Frame: 8 months
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)
Time Frame: 8 months
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+)
Time Frame: 8 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The New School

Investigators

  • Principal Investigator: Adam Brown, PhD, The New School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EASE
  • 000001 (Other Grant/Funding Number: New York City Mayors Office Community Mental Health)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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