Substance AbuseYOURSNCT07846735
Youth Overdose & Use Reduction in Rural Systems
A study testing Navigator - Flexible Care Management in people with Substance Abuse and Opioid Abuse (Disorder), run by Seattle Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Substance Abuse, Opioid Abuse (Disorder), Overdose Prevention
- What is being tested?
- Navigator - Flexible Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: YOURS Study: Youth Overdose & Use Reduction in Rural Systems
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.
Read more
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.
Read the detailed description
Youth involved in the legal system (YILS) have some of the highest rates of substance and opioid use disorders (SUD/OUD) nationally; but few have access to adequate resources to prevent serious sequelae. SUD prevention and overdose prevention interventions for YILS are critically important to delay escalation to synthetic opioids and prevent fatalities and other health, and legal consequences.
Washington State is facing an overdose crisis; between August 2022 and 2023, overdose deaths in this state increased by 40%, a steeper increase than any other state. Rural counties in this state report overdose rates that are as high or higher than urban ones. YILS, even those without OUD, are especially vulnerable to unintentional overdose; amongst YILS incarcerated in Washington State system completing a drug and alcohol assessment, 58% had experienced an overdose at some point in the past (unpublished data). Substance use resources in this and other states for rural YILS are critical and sparse.
Working with counties on a prevention strategy will further the goal of intervening with YILS who are, on average, earlier in the spectrum of legal and substance use involvement. Prior to this trial, the research team completed a codesign process with various stakeholders to design an intervention. Codesign invites people with lived experience to the design process with the goal of designing a more effective intervention. The codesign group consisted of youth and caregivers with lived experience with substance use or the juvenile court system, behavioral health providers, funding sector representatives, and juvenile county court administrators.Participating counties will be randomized into 6 clusters of the stepped wedge design. Control group participant data collection will begin for all counties at the same time. Clusters of counties will step into the implementation stage every 3-months. When counties move into the implementation stage, intervention group participant data collection will immediately begin.
- Conditions
- Substance Abuse, Opioid Abuse (Disorder), Overdose Prevention, Substance Use Disorder (SUD), Adolescent Substance Use, Rural Health
- Being tested
- Navigator - Flexible Care Management
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator - Flexible Care ManagementBehavioural
Also called Care Management, ACRA/ACC, Assertive Continuing Care (ACC)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 3- and 6-months
Number of youth receiving case management, mental health, or substance use prevention services
Primary implementation outcome - county level
Measured: Through study completion, up to 30 months
Number of naloxone kits distributed
Primary implementation outcome - county level
Measured: Through study completion, up to 30 months
Secondary outcomes (5)
Number of days of using other individual non-alcohol/non-cannabis substances
Measure taken from the HEAL Prevention Cooperative Common Core Measures
Measured: 3- and 6- months
Substance use refusal self-efficacy
How confident youth are resisting substances.
Measured: 3- and 6-months
Percent of youth reporting receipt of naloxone
Percent of youth receiving naloxone, a medication to reverse an opioid overdose.
Measured: 3 months
Number of youth receiving overdose prevention education
Secondary implementation outcome - county level
Measured: Through study completion, up to 30 months
Number of court staff receiving overdose prevention education
Secondary implementation outcome - county level
Measured: Through study completion, up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped Wedge, Unidirectional Crossover Design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kym Ahrens, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846735
- Sponsor's protocol ID
- 2026-007-SCH
- Other IDs
- R61DA061846
- Acronym
- YOURS
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YOURS Study: Youth Overdose & Use Reduction in Rural Systems
- ClinicalTrials.gov ID
- NCT07846735
- Acronym / sponsor ID
- YOURS / 2026-007-SCH
- Conditions
- Substance Abuse, Opioid Abuse (Disorder), Overdose Prevention, Substance Use Disorder (SUD), Adolescent Substance Use, Rural Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Youth involved in the legal system (YILS) have some of the highest rates of substance and opioid use disorders (SUD/OUD) nationally; but few have access to adequate resources to prevent serious sequelae. SUD prevention and overdose prevention interventions for YILS are critically important to delay escalation to synthetic opioids and prevent fatalities and other health, and legal consequences.
Washington State is facing an overdose crisis; between August 2022 and 2023, overdose deaths in this state increased by 40%, a steeper increase than any other state. Rural counties in this state report overdose rates that are as high or higher than urban ones. YILS, even those without OUD, are especially vulnerable to unintentional overdose; amongst YILS incarcerated in Washington State system completing a drug and alcohol assessment, 58% had experienced an overdose at some point in the past (unpublished data). Substance use resources in this and other states for rural YILS are critical and sparse.
Working with counties on a prevention strategy will further the goal of intervening with YILS who are, on average, earlier in the spectrum of legal and substance use involvement. Prior to this trial, the research team completed a codesign process with various stakeholders to design an intervention. Codesign invites people with lived experience to the design process with the goal of designing a more effective intervention. The codesign group consisted of youth and caregivers with lived experience with substance use or the juvenile court system, behavioral health providers, funding sector representatives, and juvenile county court administrators.Participating counties will be randomized into 6 clusters of the stepped wedge design. Control group participant data collection will begin for all counties at the same time. Clusters of counties will step into the implementation stage every 3-months. When counties move into the implementation stage, intervention group participant data collection will immediately begin.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped Wedge, Unidirectional Crossover Design
| Arm | Type | Receives |
|---|---|---|
| Intervention: YOURS Navigator Program | Experimental | Behavioral: Navigator - Flexible Care ManagementThe 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. |
| Usual Care | No intervention | –No Navigator intervention during the control time period. The juvenile court system may refer adolescents to their usual care pathways. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigator - Flexible Care ManagementAlso: Care Management, ACRA/ACC, Assertive Continuing Care (ACC)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. | Behavioural | Intervention: YOURS Navigator Program |
Primary outcome
Overdose Prevention Knowledge
Time frame: 3- and 6-months
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.
Presence of use past 30 days (Yes/No)
Time frame: 3- and 6-months
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
Number of days using alcohol and cannabis
Time frame: 3- and 6-months
In the past 30 days, number of days youth used cannabis; in the past 30 days, number of days youth used alcohol.
Number of youth receiving case management, mental health, or substance use prevention services
Time frame: Through study completion, up to 30 months
Primary implementation outcome - county level
Number of naloxone kits distributed
Time frame: Through study completion, up to 30 months
Primary implementation outcome - county level
5 secondary outcomes
Number of days of using other individual non-alcohol/non-cannabis substances
Time frame: 3- and 6- months
Substance use refusal self-efficacy
Time frame: 3- and 6-months
Percent of youth reporting receipt of naloxone
Time frame: 3 months
Number of youth receiving overdose prevention education
Time frame: Through study completion, up to 30 months
Number of court staff receiving overdose prevention education
Time frame: Through study completion, up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Substance Abuse
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
Not yet recruitingPhase 1/2
Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder
Treatment Resistant Depression, Substance Use Disorders
RecruitingObservational study
Treatment Outcomes Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction
Voiding Dysfunction, Substance Abuse
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Enrolling by invitationObservational study
Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study
PTSD, Suicidal Thoughts and Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator - Flexible Care Management in people with Substance Abuse and Opioid Abuse (Disorder), run by Seattle Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overdose Prevention Knowledge (time frame: 3- and 6-months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.