About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Navigator - Flexible Care Management
BehavioralCare 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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
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.
Number of youth receiving case management, mental health, or substance use prevention services
Primary implementation outcome - county level
Secondary outcomes
Number of days of using other individual non-alcohol/non-cannabis substances
Measure taken from the HEAL Prevention Cooperative Common Core Measures
Substance use refusal self-efficacy
How confident youth are resisting substances.
Percent of youth reporting receipt of naloxone
Percent of youth receiving naloxone, a medication to reverse an opioid overdose.
Number of youth receiving overdose prevention education
Secondary implementation outcome - county level
Other outcomes
Presence of non-fatal overdose
Exploratory outcome, investigator-developed
Locations
Sponsors and contacts
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Seattle Children's Hospital
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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