An interventional study of Youth Substance Use Unit in Substance Use Disorders (SUDs), sponsored by University of Maryland, College Park. Not yet recruiting. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of Maryland, College Park · Not applicable, Interventional, and Treatment
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/).
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/).
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 60 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Maryland, College Park is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Youth Substance Use Unit
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.
Reach and Engagement
Reach and Engagement will be tracked through service logs, including the number of students referred, completed referrals, and retention in care.
Time frame: From enrollment to 90-day follow-up
90-day Substance Use Self Report
The timeline followback will be used to assess self-reported substance use frequency
Time frame: Measured from baseline to 90-day follow-up
90-Day Substance Use Urinalysis
Substance use will be assessed using urinalysis.
Time frame: Measured from baseline to 90-day follow-up.
Opioid-related knowledge and likelihood to engage in misuse behaviors
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.
Time frame: Assessed from baseline to 90-day follow-up
Motivation for substance use and problems associated
Motivation for substance use and problems associated will be measured with the Short Inventory of Problems
Time frame: Assessed between the baseline assessment and 90-day follow-up
Depressive Symptoms
Depressive symptoms will be assessed with the Patient Health Questionnaire-9. The Patient Health Questionnaire-9 is a 9-item self-report measure of depressive symptom severity during the preceding two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"). Item scores are summed to produce a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity and therefore a worse outcome.
Time frame: Assessed between the baseline assessment and 90-day follow-up
Anxiety Symptoms
Anxiety symptoms will be measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). The Generalized Anxiety Disorder is a 7-item self-report measure of anxiety symptom severity during the preceding two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"). Item scores are summed to produce a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity and therefore a worse outcome.
Time frame: Assessed from baseline to 90-day follow-up.
No study locations are listed for this record.
Plan to share: Yes — De-identified quantitative datasets (adolescent clinical outcomes, implementation metrics), de-identified transcripts, coded qualitative outputs (e.g., theme matrices), and strategy adaptation documentation (FRAME-IS) will be preserved and shared to enable replication, secondary analysis, and transparency in implementation research. Data will be submitted to the National Addiction and Health Data Archive Program in alignment with the HEAL Data Sharing Policy.
Supporting information: Study protocol, Analytic code
Time frame: Data will be made available no later than the time of first publication or the end of the performance period, whichever comes first. Data will be retained and available for a minimum of 10 years in accordance with NIH expectations.
Access criteria: Data will be submitted to the National Addiction and Health Data Archive Program in alignment with the HEAL Data Sharing Policy. Within one year of award, the study will be registered on the HEAL platform, including submission of HEAL-specific study-level metadata. Public-facing datasets will be assigned a persistent unique identifier (e.g., DOI) and indexed for searchability. Data will be made available no later than the time of first publication or the end of the performance period, whichever comes first. Data will be retained and available for a minimum of 10 years in accordance with NIH expectations.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Maryland, College Park