Digital Mental Health Screening, Feedback, and Referral System for Teens With Socially Complex Needs: Protocol for a Randomized Controlled Trial Integrating the Teen Assess, Check, and Heal System into Pediatric Primary Care.

IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2025-02-18 DOI:10.2196/65245
Colleen Stiles-Shields, Gabriella Bobadilla, Karen Reyes, Erika L Gustafson, Matthew Lowther, Dale L Smith, Charles Frisbie, Camilla Antognini, Grace Dyer, Rae MacCarthy, Nicolò Martinengo, Guy Morris, Alissa Touranachun, Kimberlee M Wilkens, Wrenetha A Julion, Niranjan S Karnik
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Abstract

Background: Teens with socially complex needs-those who face multiple and potentially overlapping adversities-are disproportionately affected by several barriers to mental health screening and treatment. Pediatric primary care (PPC) is a typically low-stigmatized setting for teens that is visited at least annually. As such, implementing digital mental health tools (DMH), as low-intensity treatments in PPCs may increase the reach of such tools for teens with socially complex needs.

Objective: This study aimed to evaluate the Teen Assess, Check, and Heal (TeACH) System in comparison to a control condition while integrated into PPCs at 2 Medical Centers serving teen patients in Chicago, Illinois. Through collaboration with key players throughout the design and implementation planning phases, the TeACH System is hypothesized to increase teen patient self-reported engagement with DMH and address specific individual-level barriers to mental health care, compared with a digital psychoeducation control condition.

Methods: Eligible participants will be recruited through PPC clinics housed within the University of Illinois Chicago (UIC) and Rush University Medical Center (RUSH). Recruitment involves invitations from research staff members and primary care clinicians and staff members, as well as posting flyers with QR codes at the specified clinics. All participants complete a brief demographic survey, baseline survey, and Kiddie-Computerized Adaptive Tests Anxiety Module. Participants are randomized to receive either the control condition (digital evidence-based workbook) or the intervention (TeACH System Feedback and Resources). All randomized participants will then be invited to complete an immediate and 1-week follow-up survey. The primary outcomes assess changes in engagement with DMH (ie, likelihood to use DMH for anxiety and actual DMH use) and individual-level barriers to mental health care (ie, symptom understanding and confidence to act). Descriptive analyses will be conducted to characterize the sample and usability ratings of the TeACH System. Linear or generalized linear mixed effects regression models will examine differences in primary outcomes over time.

Results: Recruitment began in July 2024 and data collection is expected to be completed by August 2025. To date, 122 teens have assented to complete study activities, 80 have been randomized (an additional 24 teens have had subthreshold anxiety symptoms and were therefore not randomized), and 42 teens have completed the 1-week follow-up assessment.

Conclusions: This study will provide preliminary feasibility data that may inform how the TeACH System and other DMH low-intensity treatments might better engage and support teens with socially complex needs.

Trial registration: ClinicalTrials.gov NCT05466929; https://clinicaltrials.gov/study/NCT05466929.

International registered report identifier (irrid): DERR1-10.2196/65245.

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具有复杂社会需求的青少年数字心理健康筛查、反馈和转诊系统:将青少年评估、检查和治疗系统纳入儿科初级保健的随机对照试验方案。
背景:具有复杂社会需求的青少年——那些面临多重和潜在重叠逆境的人——在心理健康筛查和治疗方面受到几种障碍的影响不成比例。儿科初级保健(PPC)是一个典型的低污名设置的青少年访问至少每年。因此,在PPCs中实施数字心理健康工具(DMH)作为低强度治疗可能会增加这些工具对具有复杂社交需求的青少年的覆盖范围。目的:本研究旨在评估青少年评估、检查和治疗(TeACH)系统与对照条件的比较,并将其整合到伊利诺伊州芝加哥两家为青少年患者服务的医疗中心的PPCs中。与数字心理教育控制条件相比,通过在整个设计和实施规划阶段与关键参与者的合作,假设TeACH系统可以增加青少年患者自我报告的DMH参与度,并解决特定的个人层面的心理卫生保健障碍。方法:通过伊利诺伊大学芝加哥分校(UIC)和拉什大学医学中心(Rush)内的PPC诊所招募符合条件的参与者。招募包括来自研究人员、初级保健临床医生和工作人员的邀请,以及在指定诊所张贴带有二维码的传单。所有参与者完成了简短的人口统计调查、基线调查和儿童计算机化自适应测试焦虑模块。参与者被随机分配接受控制条件(数字循证工作簿)或干预(TeACH系统反馈和资源)。然后,所有随机参与者将被邀请完成立即和为期一周的随访调查。主要结果评估与DMH接触的变化(即使用DMH治疗焦虑的可能性和实际使用DMH的可能性)和个人层面的精神卫生保健障碍(即症状理解和采取行动的信心)。将进行描述性分析,以描述TeACH系统的样本和可用性评级。线性或广义线性混合效应回归模型将检查主要结果随时间的差异。结果:2024年7月开始招募,预计2025年8月完成数据收集。到目前为止,122名青少年同意完成研究活动,80名被随机分配(另外24名青少年有阈下焦虑症状,因此不是随机分配的),42名青少年完成了为期一周的随访评估。结论:本研究将提供初步的可行性数据,为TeACH系统和其他DMH低强度治疗如何更好地吸引和支持有复杂社会需求的青少年提供信息。试验注册:ClinicalTrials.gov NCT05466929;https://clinicaltrials.gov/study/NCT05466929.International注册报告标识符(irrid): DERR1-10.2196/65245。
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