NCT07746401

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/).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
59mo left

Started Aug 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Jun 2031

First Submitted

Initial submission to the registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

3.8 years

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Substance-Related DisordersSchool Behavioral HealthRural Behavioral Health

Outcome Measures

Primary Outcomes (4)

  • Reach and Engagement

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

    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

    Measured from baseline to 90-day follow-up

  • 90-Day Substance Use Urinalysis

    Substance use will be assessed using urinalysis.

    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

    Assessed from baseline to 90-day follow-up

Secondary Outcomes (3)

  • 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.

Study Arms (1)

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.

Behavioral: Youth Substance Use Unit

Interventions

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.

Youth Substance Use Unit

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Noah S Triplett, PhD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah S Triplett, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 5, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2031

Last Updated

August 5, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.