Youth Overdose & Use Reduction in Rural Systems

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-18
SponsorSeattle Children's Hospital

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Navigator - Flexible Care Management

    Behavioral

    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.

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: Intervention: YOURS Navigator ProgramExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

Substance use refusal self-efficacy

How confident youth are resisting substances.

Time frame
3- and 6-months
3

Percent of youth reporting receipt of naloxone

Percent of youth receiving naloxone, a medication to reverse an opioid overdose.

Time frame
3 months
4

Number of youth receiving overdose prevention education

Secondary implementation outcome - county level

Time frame
Through study completion, up to 30 months

Other outcomes

1

Presence of non-fatal overdose

Exploratory outcome, investigator-developed

Time frame
3- and 6-months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seattle Children's Hospital

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: