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临床试验/NCT07539636
NCT07539636尚未招募不适用

Reaching Teens Where They Are: Integrating Digital Low-Intensity Mental Health Treatment Into Park District Teen Programming

University of Illinois at Chicago0 个研究点目标入组 268 人开始时间: 2027年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
268
主要终点
After Scenario Questionnaire (ASQ)

研究概览

简要总结

The goal of this study is first to develop and adapt a digital low-intensity treatment, "VIBE in the Parks", for adolescents and young adults (AYA) who visit programming at the Chicago Park District. A trial will occur at four Park District sites to compare how "VIBE in the Parks" works compared to a control condition (where AYA are given access to a digital workbook).

详细描述

Amid an unprecedented youth mental health crisis, adolescents and young adults (AYA) have the most barriers to receiving mental healthcare. While digital tools are a scalable and accessible way to provide timely mental health screening and referral options, these tools have failed to engage AYA in their daily lives. This failure is driven by multiple factors, including a lack of: 1) understanding of implementation determinants for digital tools in community spaces; and 2) partnership with AYA, their caregivers, and support staff who work in key community settings where AYA spend their time. The goal of this study is to target AYA engagement in the design and implementation of a digital low-intensity treatment for AYA in Chicago Park District (CPkD) Teen Programming. The CPkD is the largest park district in the country, and more than 40,000 youth are served daily across all 77 Chicago neighborhoods. This project harnesses on a partnership with CPkD and is grounded in the Accelerated Creation-to-Sustainment (ACTS) Model to guide the development of a technology ("VIBE in the Parks"), as well as its service and implementation plans for CPkD sites. Aim 1 follows the first phase of the ACTS Model, Create. Human-centered design and community-engaged research methodologies will be used to collaborate with the existing CPkD Youth Advisory Board and Teen Programming participants, caregivers of AYA served by CPkD, and CPkD staff. Design activities will focus on targeting mechanisms that are believed to influence engagement: 1) individual-level barriers to care; 2) leveraging spaces where youth spend their time, including assessing determinants in these spaces; and 3) elevating key player input throughout design. The products of Aim 1 will include: an initial version of "VIBE in the Parks" that demonstrates usability and acceptability by key players, a service protocol for integration of the "VIBE in the Parks" and potential higher clinical needs reported by AYA as a result of using the tool, and an implementation blueprint for integration into CPkD programming. Additionally, extended usability testing will pilot all trial activities to be conducted in Aim 2. In Aim 2, the second phase of the ACTS Model, Trial, will be followed by conducting a pilot randomized controlled trial in CPkD sites using an Optimization, Effectiveness, and Implementation trial methodology. The "VIBE in the Parks" will be compared to a control condition (digital workbook) across a pragmatic, rollout implementation trial. Primary outcomes include acceptability and feasibility, along with reductions of individual levels to mental healthcare, DMH use, and, secondarily, clinical outcomes (anxiety, depression). Optimization activities will occur across the trial period. In sum, the naturalistic approach of this work addresses multiple barriers to real-world digital tool engagement failures for AYA. It will provide key insights into engagement strategies, adaptations, and both service and implementation practices that will support AYA in community settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Be a participant in Chicago Park District Teen Programming at a trial site
  • Be between the ages of 13-24 years of age
  • Be able to speak and read in English

排除标准

  • Absence of the above criteria

研究组 & 干预措施

"VIBE in the Parks"

Experimental

"VIBE in the Parks" developed across Aim 1 activities

干预措施: "VIBE in the Parks" (Behavioral)

Digital Control

Active Comparator

Access to a digital self-help book

干预措施: Digital Control (Behavioral)

结局指标

主要结局

After Scenario Questionnaire (ASQ)

时间窗: Administered three times; baseline, week 2, week 4

3-items; We will use the ASQ to assess satisfaction

Kiddie Computerized Adaptive Tests, Anxiety and Depression Modules

时间窗: Administered five times; baseline and at weeks 1, 2, 3, and 4

\~1 minute to complete each self-report module, assess anxiety and depressive symptoms

TeACH System Individual Barriers and Engagement Questionnaire

时间窗: Administered 5 times, at baseline and weeks 1, 2, 3, 4

4-items; Mental Health Understanding, Confidence to Act, Likelihood to use DMH (Likert Scale); DMH Use (Y/N/Unsure)

Twente Engagement with Ehealth Technologies Scale (TWEETS)

时间窗: Administered five times, at baseline and weeks 1, 2, 3, 4

9-items; Engagement with e-health (behavior, cognition, affect)

次要结局

  • Generalized Anxiety Disorder-7 (GAD-7)(Administered twice, at baseline and week 4)
  • Patient Health Questionnaire-9 (PHQ-9)(Administered twice, at baseline and week 4)
  • Revised Children's Anxiety and Depression Scale (RCADS-25)(Administered twice, at baseline and week 4)
  • Mental Health Implementation Science Tools (mhIST, Consumer Version)(Administered three times, at baseline, weeks 2 and 4)
  • Self-Stigma of Seeking Help Scale (SSOSH)(Administered three times, at baseline, weeks 2 and 4)

研究者

申办方类型
Other
责任方
Sponsor

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