跳至主要内容
临床试验/NCT06934954
NCT06934954招募中不适用

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

The New School1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年3月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Pediatric Symptom Checklist Youth Report (Y-PSC)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: EASE (Behavioral)

结局指标

主要结局

Pediatric Symptom Checklist Youth Report (Y-PSC)

时间窗: 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".

次要结局

  • 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)
  • Alabama Parenting Questionnaire (APQ)(8 months)
  • Patient Health Questionnaire (PHQ-9)(8 months)
  • Generalized Anxiety Disorder Assessment (GAD-7)(8 months)
  • Kessler's Psychological Distress Scale (K6+)(8 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Brown, Ph.D.

Principal Investigator

The New School

研究点 (1)

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