NCT07846735

Brief Summary

The goal of this study is to conduct a clinical trial to understand effects of providing multilevel intervention to young people in the legal system. The multilevel intervention includes flexible care management using ACRA/ACC principles, family support, and overdose education. This study aims to test the implementation strategy, as well as the outcomes of the intervention with participants. The first question the study will address is how successful was implementation. This will be measured by the number of youth receiving case management, family support, naloxone supplies, and overdose prevention curricula, and adoption by the participating county court systems. The second question the study will address is whether the intervention impacted youth behavioral outcomes, such as overdose risk awareness, knowledge of how to use naloxone, and number of days per month using substances. Researchers will compare youth who received the intervention to youth who received usual treatment to see if the intervention increases overdose risk awareness and knowledge, and decreases frequency of substance use. Participants will receive the intervention (if assigned to) and complete study surveys. Participating counties will provide data on implementation, and site visits will also be performed to track each county's performance.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Oct 2026

Typical duration 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

First Submitted

Initial submission to the registry

July 16, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

July 16, 2026

Last Update Submit

September 22, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Overdose Prevention Knowledge

    Youth knowledge on how to prevent and/or respond to an overdose. Assessed using the Opioid Overdose Knowledge Scale (OOKS). Scores range from 0-45 and a higher score is considered a better outcome.

    3- and 6-months

  • Presence of use past 30 days (Yes/No)

    Use of any overdose associated substance (opioids, benzodiazepines, alcohol, or stimulants) in the past 30 days; use of any substance in the past 30 days

    3- and 6-months

  • Number of days using alcohol and cannabis

    In the past 30 days, number of days youth used cannabis; in the past 30 days, number of days youth used alcohol.

    3- and 6-months

  • Number of youth receiving case management, mental health, or substance use prevention services

    Primary implementation outcome - county level

    Through study completion, up to 30 months

  • Number of naloxone kits distributed

    Primary implementation outcome - county level

    Through study completion, up to 30 months

Secondary Outcomes (5)

  • Number of days of using other individual non-alcohol/non-cannabis substances

    3- and 6- months

  • Substance use refusal self-efficacy

    3- and 6-months

  • Percent of youth reporting receipt of naloxone

    3 months

  • Number of youth receiving overdose prevention education

    Through study completion, up to 30 months

  • Number of court staff receiving overdose prevention education

    Through study completion, up to 30 months

Other Outcomes (1)

  • Presence of non-fatal overdose

    3- and 6-months

Study Arms (2)

Intervention: YOURS Navigator Program

EXPERIMENTAL

The intervention consists of a navigator stationed in each participating county or shared by neighboring counties. The navigator will deliver a flexible care management intervention, including direct services and referrals to court-involved youth in rural Washington counties.

Behavioral: Navigator - Flexible Care Management

Usual Care

NO INTERVENTION

No Navigator intervention during the control time period. The juvenile court system may refer adolescents to their usual care pathways.

Interventions

Care Navigator who will work with youth and families to address mental health, substance use, and other unmet needs, both through direct support services as well as referrals to adjunctive agencies. The flexible care management intervention may include goal setting, skill building, contingency management, motivational interviewing, overdose prevention and education, mental health and substance first aid, and basic needs support. The Navigator will work closely with the youth for 3-months, and as-needed up to 6-months.

Also known as: Care Management, ACRA/ACC, Assertive Continuing Care (ACC)
Intervention: YOURS Navigator Program

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Youth age 14-18
  • Current juvenile court-involvement or receiving services from a participating county court (includes detention, diversion, truancy, at-risk youth, etc.)
  • Received a REDCap link or QR code and study participation code from authorized county staff

You may not qualify if:

  • Youth age 13 and under
  • Youth who do not receive a study participation code from an authorized county contact
  • Unable to participate due to significant mental health or developmental issue precluding meaningful participation in study procedures and/or intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related DisordersOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped Wedge, Unidirectional Crossover Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2026

First Posted

September 29, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified data will be shared with investigators who propose a specific data analysis plan that is reviewed and approved by study PIs, unless prohibited by NIDA, IRB, or another regulatory body (e.g., DSMB).

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD and supporting information will be available at the end of the study (March 2029) for up to 5 years (through February 2034).
Access Criteria
Investigators need to submit a brief description of how they will use the data to our team to access data and supporting information. Investigators will send a dataset once the project is approved.