Early Adolescent Skills for Emotions

Not Applicable

Recruiting

• Conditions: Community Mental Health Services

• Registration Number: NCT06934954
• Lead Sponsor: The New School

Brief 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.

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.

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 Timeline

• Study Start: 2025-03-17
• Study First Submitted: 2025-03-27
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-11-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pediatric Symptom Checklist Youth Report (Y-PSC)	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".

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire - Adolescent Version (PHQ-A)	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".
Warwick Edinburgh Well-being Scale (WEMWBS)	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".
Impairment of Daily Function	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".
Psychological Sense of School Membership (PSSM)	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.
Parental Stress Scale (PSS)	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.
Alabama Parenting Questionnaire (APQ)	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".
Patient Health Questionnaire (PHQ-9)	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".
Generalized Anxiety Disorder Assessment (GAD-7)	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".
Kessler's Psychological Distress Scale (K6+)	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".

Trial Locations

Locations (1)

The New School Center for Global Mental Health; 🇺🇸 New York, New York, United States