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临床试验/NCT06419595
NCT06419595尚未招募不适用

Screening and Support for Youth

Cambridge Health Alliance0 个研究点目标入组 220 人开始时间: 2026年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
220
主要终点
Completion of Single session intervention

研究概览

简要总结

To adapt the Screening and Support for Youth (SASY) intervention and approach to recruitment for racial, ethnic and linguistic diverse youth aged 12-17 in the Denver Health catchment area

详细描述

To adapt the Screening and Support for Youth (SASY) intervention and approach to recruitment for racial, ethnic and linguistic diverse youth aged 12-17 in the Denver Health catchment area.

Includes the recruitment of 220 youth (170 from schools/community and 50 hard-to-reach).

170 participants will be recruited by QR codes available on flyers that will be distributed in schools and community settings. This group will then be randomized to either follow up with the Engaging Youth Expertise for Prevention (EYE) or one of the study team's Research Coordinators (RC) and either EYE or the RC will carry out the assent/consent process with youth and their parents/guardians. For the subsequent (non-randomized) group of 50 hard-to-reach participants, the EYE team will utilize various methods for recruitment, and coordinate the assent/consent process with youth and their parents/guardians.

All 200 participants will be offered a SASY screening which will include the K-CAT, Weiss Functional Impairment Scale (WFIRS-S), CAT-MH social determinants of health (SDOH), and assessment of current mental health treatment. All survey instruments will be delivered via REDCap. Each participant will be assigned a record identification (ID) and an acrostic, so their data can not be identifiable during analysis. All data will stay within the Cambridge Health Alliance (CHA) firewall and only the study team will have access to the results. These products are available in English and Spanish.

A clinical risk score is generated by an algorithm combining symptoms and functional impairment based on national norms. Tier 1 is within normal, Tier 2 is at clinical risk, and Tier 3 is clinically ill. All participants will receive a motivational feedback session to discuss the results of the screening. The discussion will focus on the participant's reflections on how they feel, their perception of their symptoms and functioning, what changes they wish to make in their life, and what might support that change. The feedback will be given to the teens using non-clinical and non-research terms based upon the students' responses on the screening measures. Tier 1 participants will be offered screening and feedback on the screening results. Tier 2 participants will be offered screening, feedback on the screening results and a single session intervention (SSI). Tier 3 participants will be offered screening, feedback on the screening results, a single session intervention and information on community resources. The SSI will be accessed by a unique link provided to the participants, and includes several modules to choose from that participants can complete on their own and at their own pace.

研究设计

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

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 12 to 17 year old teens

排除标准

  • younger than 12 or older than 17

结局指标

主要结局

Completion of Single session intervention

时间窗: 1 month following initial screening

Number and proportion of participants in Tiers 2 and 3 that start and/or complete the single session intervention. This will be a measure of engagement in services.

Participation

时间窗: Immediate at time of enrollment

Total number and proportion of 12-17 year olds recruited by the Research Coordinator vs. EYE Youth Researchers; also will examine this by proportion racial, ethnic and linguistic (REL) minoritized youth who participate (comparing Research Coordinator vs. EYE)

次要结局

  • Therapeutic Alliance(1 month following initial screening)
  • Engagement in Mental Health Treatment/Behavioral Change Activities(1 month following initial screening)
  • K-CAT/WFIRS scores - preliminary effectiveness(1 month following initial screening)

研究者

申办方类型
Other
责任方
Sponsor

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