NCT06934954

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 17, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

March 27, 2025

Last Update Submit

April 10, 2025

Conditions

Keywords

Youth Mental HealthAdolescent Mental HealthCommunity Mental Health

Outcome Measures

Primary Outcomes (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".

    8 months

Secondary Outcomes (9)

  • Patient Health Questionnaire - Adolescent Version (PHQ-A)

    8 months

  • Warwick Edinburgh Well-being Scale (WEMWBS)

    8 months

  • Impairment of Daily Function

    8 months

  • Psychological Sense of School Membership (PSSM)

    8 months

  • Parental Stress Scale (PSS)

    8 months

  • +4 more secondary outcomes

Study Arms (1)

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.

Behavioral: EASE

Interventions

EASEBEHAVIORAL

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

EASE Intervention

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adolescents
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New School Center for Global Mental Health

New York, New York, 10011, United States

RECRUITING

Related Publications (9)

  • 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.

    PMID: 36858980BACKGROUND
  • 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.

    PMID: 34339320BACKGROUND
  • 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.

    PMID: 35301042BACKGROUND
  • 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.

    PMID: 30600639BACKGROUND
  • 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.

    PMID: 21056345BACKGROUND
  • 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.

    PMID: 36177440BACKGROUND
  • 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.

    PMID: 33763401BACKGROUND
  • 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.

    PMID: 37748283BACKGROUND
  • 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.

    PMID: 35960704BACKGROUND

Study Officials

  • Adam Brown, PhD

    The New School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 18, 2025

Study Start

March 17, 2025

Primary Completion

November 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

April 18, 2025

Record last verified: 2025-04

Locations