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NCT Number: NCT07746401

Recovery Opportunities Through Ongoing Treatment Sustainment

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/).

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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/).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Youth Substance Use Unit

Behavioral

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.

Primary outcomes

  1. Reach and Engagement

    Time frame: 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.

  2. 90-day Substance Use Self Report

    Time frame: Measured from baseline to 90-day follow-up

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

  3. 90-Day Substance Use Urinalysis

    Time frame: Measured from baseline to 90-day follow-up.

    Substance use will be assessed using urinalysis.

  4. Opioid-related knowledge and likelihood to engage in misuse behaviors

    Time frame: 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

Secondary outcomes

  1. Motivation for substance use and problems associated

    Time frame: Assessed between the baseline assessment and 90-day follow-up

    Motivation for substance use and problems associated will be measured with the Short Inventory of Problems

  2. Depressive Symptoms

    Time frame: Assessed between the baseline assessment and 90-day follow-up

    Depressive symptoms will be assessed with the Patient Health Questionnaire-9

  3. Anxiety Symptoms

    Time frame: Assessed from baseline to 90-day follow-up.

    Anxiety symptoms will be measured with the Generalized Anxiety Disorder-7 scale

Study contacts

Contact information is provided by the study sponsor or research team.

Noah S Triplett, PhD

CONTACT

[email protected]

(301) 405-5862

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: ROOTS

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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