Clinical trial NCT06934954: Early Adolescent Skills for Emotions
Official title: Adapted Early Adolescent Skills for Emotions (EASE) to Decrease Psychological Distress Among Urban Youth and Caregivers in NYC: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Community Mental Health Services
Keywords: Youth Mental Health
Adolescent Mental Health
Community Mental Health
Lead sponsor: The New School
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pediatric Symptom Checklist Youth Report (Y-PSC)
timeFrame: 8 months
Secondary outcomes:
measure: Patient Health Questionnaire - Adolescent Version (PHQ-A)
timeFrame: 8 months
measure: Warwick Edinburgh Well-being Scale (WEMWBS)
timeFrame: 8 months
measure: Impairment of Daily Function
timeFrame: 8 months
measure: Psychological Sense of School Membership (PSSM)
timeFrame: 8 months
measure: Parental Stress Scale (PSS)
timeFrame: 8 months
measure: Alabama Parenting Questionnaire (APQ)
timeFrame: 8 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 8 months
measure: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: 8 months
measure: Kessler's Psychological Distress Scale (K6+)
timeFrame: 8 months
Other outcomes:
Locations:
city: New York
country: United States
facility: The New School Center for Global Mental Health
state: New York
Study officials:
affiliation: The New School
name: Adam Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.