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临床试验/NCT07746401
NCT07746401尚未招募不适用

Recovery Opportunities Through Ongoing Treatment Sustainment (ROOTS): A Dynamic Approach to Integrate and Sustain Adolescent Substance Use Services in Rural Schools

University of Maryland, College Park0 个研究点目标入组 60 人开始时间: 2026年9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
60
主要终点
Reach and Engagement

研究概览

简要总结

Adolescents in rural communities face limited access to effective substance use services, increasing their risk for opioid and other substance use disorders. This project will use an adaptive, iterative implementation approach to improve the integration of external substance use service providers into rural school settings. Findings will inform strategies to integrate and scale adolescent substance use services in schools. Support for this trial is provided by the HEAL Initiative (https://heal.nih.gov/).

详细描述

Rural adolescents are more likely than their peers in urban areas to engage in high-risk substance use, including opioid misuse. Rural adolescents also face challenges accessing behavioral care because of limited clinics and providers in rural settings, including substance use care providers. External specialists may fill a critical gap in augmenting existing school-based services; however, challenges in cross-system coordination contribute to poor reach and retention in care. These challenges are particularly urgent given the need to treat opioid use disorder (OUD) and prevent escalation to OUD among high-risk adolescents with other substance use disorder (SUD) or behavioral health challenges. Research is needed to identify implementation strategies that support cross-system coordination without overburdening existing school staff. The proposed K23 will examine the implementation and effectiveness of an innovative community partnership-the Youth Substance Use Unit (YSU), a collaboration between schools and local substance use service providers that delivers services to adolescents with substance use problems at high schools on the rural Eastern Shore of Maryland. Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, the study has three aims: (1) identify determinants and opportunities to improve implementation of the YSU by conducting semi-structured interviews with constituents (e.g., school personnel, peer recovery specialists); (2) develop and adapt initial implementation strategies to improve reach and implementation of the YSU into rural schools based on constituent feedback using Implementation Mapping, a participatory approach to co-develop and specify implementation strategies; and (3) test the effectiveness and implementation of the YSU in Type 2 hybrid effectiveness-implementation trial using an adaptive-iterative design. Support for this trial is provided by the HEAL Initiative (https://heal.nih.gov/).

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
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Are enrolled in one of the participating schools
  • Are referred or independently access YSU services;
  • Are above age of 13

排除标准

  • Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
  • Inability to understand the study and provide informed consent in English

研究组 & 干预措施

Youth Substance Use Unit

Experimental

The YSU provides adolescents access to several evidence-based interventions, including access to an on-site substance use counselor trained in evidence-based practices for adolescent SUD, peer recovery specialists, and, if indicated, virtual access to an OUD treatment provider and/or clinical psychologist for more acute and co-occurring disorder treatment.

干预措施: Youth Substance Use Unit (Behavioral)

结局指标

主要结局

Reach and Engagement

时间窗: From enrollment to 90-day follow-up

Reach and Engagement will be tracked through service logs, including the number of students referred, completed referrals, and retention in care.

90-day Substance Use Self Report

时间窗: Measured from baseline to 90-day follow-up

The timeline followback will be used to assess self-reported substance use frequency

90-Day Substance Use Urinalysis

时间窗: Measured from baseline to 90-day follow-up.

Substance use will be assessed using urinalysis.

Opioid-related knowledge and likelihood to engage in misuse behaviors

时间窗: Assessed from baseline to 90-day follow-up

Opioid-related knowledge and likelihood to engage in misuse behaviors will be assessed with the Adolescent Opioid Safety and Learning scale. The Adolescent Opioid Safety and Learning Scale is a 16-item instrument comprising four separately scored subscales: Opioid Learning Interest (5 items; summed score range 5-25, with higher scores indicating greater interest in learning about opioid safety), Opioid Misuse Behavior Recognition (4 yes/no items; summed score range 0-4, with higher scores indicating better recognition of opioid misuse), Likelihood to Misuse Opioids (4 items; summed score range 4-20, with higher scores indicating a greater likelihood of opioid misuse and therefore a worse outcome), and Opioid Harm (3 items; summed score range 3-15, with higher scores indicating greater perceived harm from opioid misuse). The four subscales will be analyzed separately.

次要结局

  • Motivation for substance use and problems associated(Assessed between the baseline assessment and 90-day follow-up)
  • Depressive Symptoms(Assessed between the baseline assessment and 90-day follow-up)
  • Anxiety Symptoms(Assessed from baseline to 90-day follow-up.)

研究者

申办方类型
Other
责任方
Sponsor

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