An interventional study of Navigator - Flexible Care Management in Substance Abuse, Opioid Abuse (Disorder) and Overdose Prevention, sponsored by Seattle Children's Hospital. Not yet recruiting. Open to participants aged 14 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Health services research
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.
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.
Exclusion Criteria:
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
No Navigator intervention during the control time period. The juvenile court system may refer adolescents to their usual care pathways.
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)
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.
Time frame: 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
Time frame: 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.
Time frame: 3- and 6-months
Number of youth receiving case management, mental health, or substance use prevention services
Primary implementation outcome - county level
Time frame: Through study completion, up to 30 months
Number of naloxone kits distributed
Primary implementation outcome - county level
Time frame: Through study completion, up to 30 months
Number of days of using other individual non-alcohol/non-cannabis substances
Measure taken from the HEAL Prevention Cooperative Common Core Measures
Time frame: 3- and 6- months
Substance use refusal self-efficacy
How confident youth are resisting substances.
Time frame: 3- and 6-months
Percent of youth reporting receipt of naloxone
Percent of youth receiving naloxone, a medication to reverse an opioid overdose.
Time frame: 3 months
Number of youth receiving overdose prevention education
Secondary implementation outcome - county level
Time frame: Through study completion, up to 30 months
Number of court staff receiving overdose prevention education
Secondary implementation outcome - county level
Time frame: Through study completion, up to 30 months
Presence of non-fatal overdose
Exploratory outcome, investigator-developed
Time frame: 3- and 6-months
No study locations are listed for this record.
Plan to share: 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).
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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