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Recovery Opportunities Through Ongoing Treatment Sustainment

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07746401
Acronym
ROOTS
Enrollment
60
Registered
2026-08-05
Start date
2026-09-01
Completion date
2031-06-01
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders (SUDs)

Keywords

Substance-Related Disorders, School Behavioral Health, Rural Behavioral Health

Brief summary

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/).

Detailed description

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/).

Interventions

BEHAVIORALYouth 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.

Sponsors

University of Maryland, College Park
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study builds on an innovative community partnership, the Youth Substance Use Unit (YSU), which serves adolescents with substance use problems at high schools on the Eastern Shore of Maryland. 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.

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reach and EngagementFrom enrollment to 90-day follow-upReach 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 ReportMeasured from baseline to 90-day follow-upThe timeline followback will be used to assess self-reported substance use frequency
90-Day Substance Use UrinalysisMeasured from baseline to 90-day follow-up.Substance use will be assessed using urinalysis.
Opioid-related knowledge and likelihood to engage in misuse behaviorsAssessed from baseline to 90-day follow-upOpioid-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.

Secondary

MeasureTime frameDescription
Motivation for substance use and problems associatedAssessed between the baseline assessment and 90-day follow-upMotivation for substance use and problems associated will be measured with the Short Inventory of Problems
Depressive SymptomsAssessed between the baseline assessment and 90-day follow-upDepressive 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.
Anxiety SymptomsAssessed from baseline to 90-day follow-up.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.

Contacts

CONTACTNoah S Triplett, PhD
ntrip7@umd.edu(301) 405-5862
PRINCIPAL_INVESTIGATORNoah S Triplett, PhD

University of Maryland, College Park

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026