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. Author manuscript; available in PMC: 2026 Feb 1.
Published in final edited form as: Contemp Clin Trials. 2024 Dec 18;149:107782. doi: 10.1016/j.cct.2024.107782

Development of the Positive Outcomes through Supported Transition (POST) opioid preventive intervention for youth in the legal system: Study protocol for a sequential multiple assignment randomized trial

Ahnalee M Brincks 1, Kevin P Haggerty 2, Alexandria Kolberg 3, Katie M Albertson 3, Carolyn A McCarty 3,4, Margaret R Kuklinski 2, Ted Ryle 4, Kym R Ahrens 2
PMCID: PMC11788021  NIHMSID: NIHMS2044089  PMID: 39706330

Abstract

Adolescents and young adults in the legal system (AYALS) are at high risk for opioid use disorder (OUD). Effective, efficient interventions to prevent OUD that support youth as they transition to the community are needed. The Positive Outcomes through Supported Transition intervention trial is designed to identify the optimal intensity and sequence of behavioral skills and case management components for OUD prevention.

This sequential, multiple assignment randomized trial addresses three research questions: 1.whether to begin with a high-intensity, broad-scope intervention (Enhanced Adolescent Community Reinforcement Approach; E-ACRA) or a lower intensity intervention (Assertive Community Support; ACS), 2. whether to continue with E-ACRA or step-down to ACS after release, and 3. whether to step-up to E-ACRA or continue ACS for youth reporting problematic substance use after release.

Youth committed to state custody will be recruited prior to their release and randomized to E-ACRA or ACS. At five weeks post-release, E-ACRA participants will be re-randomized to E-ACRA or ACS. ACS participants reporting problematic substance use at five weeks will be re-randomized to E-ACRA or ACS. Primary analyses will test the effects of initial intervention (E-ACRA vs. ACS); secondary analyses will test the effects of second-stage interventions. Cost-effectiveness analysis will determine whether the additional resources deployed to E-ACRA are justified economically by the outcomes achieved.

Prevention is critical for this population. High-intensity interventions can be burdensome for participants (and agencies) and costly to deliver. This study examines how best to sequence high and low intensity interventions to maximize beneficial outcomes for the most youth.

Keywords: Prevention, Juvenile Justice, Adolescents, Emerging Adults, Adaptive Intervention

Adolescents and young adults in the legal system (AYALS) have some of the highest rates of opioid use disorders (OUDs) in the United States. Several studies suggest that youth and young adults who are arrested and detained within the juvenile or criminal legal systems are at greatest risk of non-medical opioid or heroin use (Sung et al., 2005; Vaughn et al., 2012), with rates of past-year opioid misuse as high or higher than 20% in juvenile correctional care settings (Sung et al., 2005; Vaughn et al., 2012). In contrast, rates of misuse in a recent general population sample of similar age youth ranged from 2.07% to 12.25% depending on age and birth year cohort (Warren et al., 2023); thus, rates of misuse in legally involved youth may be 2 to 10 times higher than their peers. Non-opioid substance use in “deep end” AYALS (i.e., incarcerated/formerly incarcerated youth) is nearly ubiquitous (Prinz & Kerns, 2003; Mulvey et al., 2010; Field et al., 2023). Further, non-opioid substance use is a critical risk factor for OUD (Sung et al., 2005; Tucker et al., 2020). One-third to one-half of AYALS exhibit a diagnosable substance use disorder, and the majority exhibit problematic use of some type (Borschmann et al., 2020; Grisso, 2004; Mulvey et al., 2010; Mulvey et al., 2014; Shufelt & Cocozza, 2006). This is likely due in part to disproportionately high rates of exposure to trauma and other early adverse experiences (Charak et al., 2019; Perez et al., 2016).

Multiple longitudinal studies have shown that among adolescents and young adults, use of alcohol, marijuana, and other non-opioid substances are a critical link in the pathway to OUD (Cheng et al., 2018; Ghandour et al., 2013; Grisso 2004; Jones et al., 2019; Mulvey et al., 2010; Sung et al., 2005; Vaughn et al., 2012; Wojceichowski, 2019,). Among AYALS, OUD and other SUDs, in turn, are critical risk factors for recidivism (Mulvey et al., 2010; Scott et al., 2018). This cycle is extremely costly, both for the youth and their families and for the legal system (The National Center for Addiction and Substance Abuse Research, 2004). Trauma-informed approaches to prevent the initiation of SUD/OUD and interrupt escalation from SUD to OUD are acutely needed in this population.

This paper presents the study design and intervention protocol for the Positive Outcomes through Supported Transitions (POST) trial. This trial builds on a pilot study demonstrating the feasibility of, and refining the eligibility, consent, measurement and content of POST for AYALS (Ahrens et al., in press). “The primary aims of this trial are twofold. First, consistent with the goal of a SMART experiment within the optimization stage of the Multiphase Optimization Strategy (Collins & Kugler, 2018), this trial aims to inform the development of a sequenced, possibly adaptive intervention for AYALS to prevent opioid use and OUD after transition from juvenile incarceration facilities to the community. The second aim is to evaluate cost-effectiveness.”

Intervention

The Adolescent Community Reinforcement Approach with Assertive Continuing Care (A-CRA/ACC) is a behavioral skills-based program based on the theories of operant conditioning and social systems. The interventionist works with the client to understand positive and negative consequences of their substance use and prosocial behaviors, and to learn skills that promote a non-harmful lifestyle. The main goals of youth sessions are to promote a positive working relationship between the adolescent and the interventionist, positive social activities and peer and family relationships, and abstinence or reduction of substance use. Goals of caregiver sessions, which are optional, include motivating the caregiver to participate in A-CRA (and to encourage adolescent participation) and helping the adolescent decrease or eliminate substance use. Classically, the ACC component, which consists of home visits and active linkage to community resources over a 3-month period, is conducted after the A-CRA component. These interventions have been used in multiple longitudinal trials, including among youth in the legal system and to reduce adolescent opiate use (Godley et al., 2001; Godley et al., 2011; Godley et al., 2014; Godley et al., 2016; Godley et al., 2017; Henderson et al., 2016; Meyers et al., 2011). The intervention weaves together motivational interviewing (Miller & Rollnick, 1991) and skills-based trauma intervention (Ford et al., 2012; Goossens et al., 2016) to achieve effective recruitment/engagement and address untreated trauma and its effects on substance use patterns (Fleming et al., 2013). A-CRA with and without the ACC component has demonstrated to be highly effective in decreasing substance use in youth with existing SUD or OUD, including in AYALS populations, with effect sizes ranging from moderate to large depending on the substance-related outcome studied (Godley et al., 2011; Godley et al., 2014; Godley et al., 2017; Henderson et al., 2016; Meyers et al., 2011; Fleming et al., 2013).

Aims

There is scarce evidence for effective opioid/OUD prevention strategies for adolescents and young adults; however, because A-CRA/ACC has consistently demonstrated impacts on the reduction or elimination of substance misuse, including opioid misuse in youth with prior use histories we chose it for this novel opioid prevention study. Whether A-CRA/ACC will be effective at preventing initiation of opioids or escalation to OUD among youth involved in the legal system is unknown. For AYALS already struggling with non-opioid SUD, the full A-CRA/ACC intervention, especially if combined with skills training to address post-traumatic stress and methods to enhance initial intervention engagement, may be the most effective and cost-beneficial way to prevent OUD. However, the full intervention may not be needed by all youth, nor at all times during the transition to the community. Thus, our overall goal is to identify a high-quality adaptive intervention (AI) or intervention sequence that adjusts the intensity and dose of intervention based on the dynamic substance use behaviors of the youth as they transition from the legal setting back to the community.

This work is guided by three critical scientific questions: (a) Among AYALS, are 3-month and 6-month post-release outcomes better when a preventive intervention begins with a more intense or less intense transition intervention component?, (b) Among youth who begin with a high intensity transition intervention, are their 3-month and 6-month post-release outcomes better if they continue that high-intensity intervention beyond five weeks after release, or step-down at five weeks after release to a lower-intensity intervention?, and (c) Do youth who begin with a lower-intensity transition intervention and report problematic substance use five weeks after release have better 3-month and 6-month post-release outcomes if the intensity of the initial intervention is increased compared to continuing at the same intensity? These research questions need to be addressed to develop a high-quality adaptive intervention or intervention sequence in this setting, which could later be evaluated against a suitable control condition in an efficacy or effectiveness trial. Moreover, the study also sought to understand whether the full A-CRA/ACC intervention was more cost-effective than the less intensive alternative in relation to outcomes achieved. This information could help guide future decisions about which intervention or interventions to reduce SUD and OUD in AYALS to support, given limited investment dollars.

HEAL Prevention Cooperative

This study is one of 10 research projects funded by the National Institutes of Health through the Helping to End Addiction Long-term (HEAL) Prevention Initiative (https://heal.nih.gov/; Coady & Nadal, 2023). These 10 projects make up the HEAL Prevention Cooperative and are collectively focused on developing, testing, implementing, and sustaining interventions intended to prevent the initiation and escalation of opioid misuse among adolescents and young adults across a range of settings, including juvenile legal systems.

Method

Study Design

Because the goal of this study is to develop a sequenced, possibly adaptive, intervention, we chose a sequential multiple assignment randomized trial (SMART) for the study design (Figure 1). In this design, all participants will be randomized with equal probability to an initial intervention phase of either 12 sessions of Enhanced-ACRA (E-ACRA), a high-intensity, broad-scope intervention that combines A-CRA/ACC and trauma affect regulation (Ford et al., 2018; Ford et al., 2013; Ford et al., 2012; Ford et al., 2011), or to eight sessions of Assertive Community Support (ACS), a lower intensity intervention that combines goal-setting with ACC case management using a trauma-informed approach. Five weeks after release from confinement, participants who were initially randomized to E-ACRA will be re-randomized with equal probability to either eight weeks of continued E-ACRA (condition A) or four weeks of the lower intensity ACS intervention (condition B). Among participants who are initially randomized to ACS, the tailoring variable of self-report substance use will be assessed about five weeks post-release by the interventionist. Youth initially randomized to ACS and reporting problematic substance use five weeks post-release will be re-randomized with equal probability to either four more weeks of ACS (condition D) or eight weeks of E-ACRA (condition E). Participants who are initially randomized to ACS and do not report problematic substance use will continue with four more weeks of ACS (condition C). If participants initially randomized to ACS do not provide data on problematic substance use at five weeks post-release, their baseline level of problematic substance use will be used to determine whether they will continue with ACS (if they report no problematic use at baseline) or will be re-randomized (if they report problematic use at baseline). In this SMART, all participants will receive 12–20 weeks of preventive intervention, varying in intensity and scope.

Figure 1:

Figure 1:

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Study Design

This SMART includes four embedded interventions (Table 1). Two of these interventions are non-adaptive single interventions that deliver E-ACRA (intervention 1) or ACS (intervention 3) regardless of self-reported problematic substance use five weeks post-release. Intervention 2 is an intervention sequence that begins with E-ACRA, followed by ACS for all participants regardless of self-reported problematic substance use five weeks post-release. Intervention 4 is an adaptive intervention that begins with ACS, continues with ACS for youth reporting no problematic substance use at five weeks post-release, and switches to E-ACRA for youth reporting problematic substance use at five weeks post-release. ACS is not delivered standardly as part of usual treatment in juvenile justice settings, but instead is being tested as a lower-intensity alternative to E-ACRA for the purpose of substance use reduction. The interventions are described in more detail below.

Table 1.

Description of the four intervention sequences embedded within the study design.

Embedded Intervention Stage-1 Intervention Stage-2 Intervention for Youth Reporting No Problematic Substance Use Stage-2 Intervention for Youth Reporting Problematic Substance Use Type of Embedded Intervention Experimental Conditions in Figure 1 Consistent with this Embedded Intervention
1 E-ACRA E-ACRA E-ACRA Non-adaptive single intervention A
2 E-ACRA ACS ACS Non-adaptive intervention sequence B
3 ACS ACS ACS Non-adaptive single intervention C + D
4 ACS ACS E-ACRA Adaptive intervention C + F
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Primary Research Question

The primary research question is to determine whether 3-month post-release substance use outcomes are better among youth receiving an intervention that begins with E-ACRA compared to youth receiving an intervention that begins with ACS. We hypothesize that youth beginning with E-ACRA will report fewer days using any substance compared to youth beginning with ACS. Secondary outcomes include past 30 days opioid use, past 30 days use of other specific substances, recidivism at 6- and 12-months, communication, problem-solving, and alcohol/drug refusal skills at 3-month and 6-month post-release assessments.

Secondary Research Questions

There are two key secondary research questions in this study. This first is to examine whether youth who continue with the high-intensity preventive intervention following initial E-ACRA report fewer days using any substances at three months post-release compared to those who switch to the lower-intensity preventive intervention following E-ACRA. The second is to examine whether increasing intensity and scope to E-ACRA for youth who began with ACS and report problematic substance use at five weeks post-release results in better 3-month post-release substance use outcomes than participants continuing with ACS.

Cost Effectiveness

Cost-effectiveness analysis (CEA) provides a systematic method for comparing the costs and impacts of different strategies for achieving the same outcome. An overall objective is to determine which strategies represent more efficient ways to achieve health objectives, that is, by having greater impact at a fixed level of investment or costing less to achieve a given improvement. Its primary use in this study will be to compare costs and 3-month substance use outcomes of an intervention that begins with E-ACRA (conditions A and B) to an intervention that begins with ACS (conditions C, D, and E). Secondary CEAs will mirror the study’s secondary aims.

Intervention Description

The focus of all interventions is on making non-use of substances more rewarding than using substances for the youth, with the goal of preventing the initiation or escalation of substance use, particularly opioid misuse. The embedded interventions differ in scope (inclusion of skills development, trauma-focused skill-building, inclusion of a support person), intensity (the frequency and length of interactions with the interventionist), and method of delivery (E-ACRA primarily in person/video call vs. ACS primarily by phone). We know that interventionists cannot just “turn off” their skills in motivational interviewing; this approach is woven into both interventions. We do believe that interventionists can adjust the scope and scale of the intervention (whether they are focusing on goals or on building skills for example).

Common Intervention Components

Common intervention elements include the use of motivational interviewing techniques (Carroll, et al., 2006; open-ended questions, affirmations, reflections, summaries, developing discrepancy, etc.), trauma-informed approach, setting and reviewing goals, and use of homework assignments to support the youth in taking action outside of sessions. See Table 2 for an overview of the intervention components.

Table 2.

Comparison of the Enhanced Adolescent Community Reinforcement Approach (E-ACRA) and Assertive Continuing Care interventions, by intervention stage.

ACS E-ACRA
Common Intervention Components Motivational Interviewing Motivational Interviewing
Trauma-Informed Trauma-Informed
Goal Setting Goal Setting
Homework assignments Homework assignments
Stage-1 Intervention Description • 1 in-person goal setting session
• 7 weekly 15-minute check-in phone calls to follow up on goals and do brief case management		 • 12 ACRA skills sessions (30–60 minutes; at least 2 sessions in-person)
• 1 ACRA session with the supportive person only (30–60 minutes)
• 2 ACRA session with the supportive person and the participant (30–60 minutes)
• Content includes skills training to address posttraumatic stress
Stage-2 Intervention Description following Stage-1 ACS • 4 weekly support check-in phone calls (~15 minutes). • 8 weekly ACRA skills sessions (30–60 minutes)
Stage-2 Intervention Description following Stage-1 E-ACRA • 4 weekly support check-in phone calls (~15 minutes) • 8 weekly ACRA Skills Check-Ins (20 minutes)
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Intervention Sequences that begin with E-ACRA

Stage-1 E-ACRA will begin prior to release. Weekly sessions will be conducted either in-person (goal of at least 4 sessions) or using video conference meetings at the facility. The goal is to conduct 8 sessions pre-release and 4 sessions post-release with the youth alone, 1 session with their support person (a trusted person who would be a positive/sober support for the youth) alone if the youth chooses to involve such a person, and 2 joint sessions with the youth and support person together if a support person is involved. The length of each session is 30–60 minutes. For those randomized to continue with E-ACRA, interventionists will continue to teach new skills and/or reinforce learned skills through 20-minute sessions, delivered in person or by video call. For those randomized to transition to ACS, interventionists will provide 15-minute support and case management sessions by phone.

Intervention Sequences that begin with ACS

Stage-1 ACS will also begin prior to release. After an initial one-hour in-person or video conference goal-setting session, weekly 15-minute support check-ins (three pre-release, four post-release) will be conducted by phone to follow up on the youth’s goals and to provide brief case management. There is no in-depth involvement of a parent or caregiver in this intervention, although there can be some degree of case management involving a parent or caregiver in ACS.

Interventions that begin with ACS include a tailoring variable assessed by the interventionist five weeks post-release. This will be a brief problematic use survey using an adaptation in which participants will report substance use in the most recent 30-day period. Participants will be identified as having problematic substance use if in the past 30 days they: a) were under 21 years of age and reported alcohol or marijuana use five or more days, suggesting at least weekly use; b) were 21 years of age or older and reported alcohol or marijuana use 22 or more days, suggesting use on most days of the week; c) were any age and reported that they used marijuana by “dabbing it”; d) were any age and reported any use of any other drugs excluding tobacco; or e) were any age and answered yes to two or more questions regarding substance-related risk behaviors and substance use disorder on the Car, Relax, Alone, Forget, Friends, Trouble measure (CRAFFT; Luow, 2016; Knight et al., 2002).

Participants meeting the criteria for problematic use five weeks post-release will be re-randomized to Stage-2 intervention. Those randomized to Stage-2 E-ACRA will receive longer (up to 60 minute) video-conference sessions focused on learning A-CRA skills. Participants without problematic use five weeks post-release will be assigned to Stage-2 ACS and brief phone sessions will be provided.

Intervention Fidelity

Intervention sessions will be audio recorded for participants who provide consent. All E-ACRA sessions will be coded for fidelity during the A-CRA certification process. After certification, each interventionist will have one session per month randomly selected for fidelity coding by expert raters from Chestnut Health. ACS sessions will be reviewed intermittently by supervisors and discussed during supervision. All interventionists will receive supervision weekly until they receive full certification, at which point supervision will occur once every 2 weeks.

Definition of Full Dose

In a sequenced intervention setting, dose depends on intervention stage. For Stage-1 E-ACRA the maximum number of sessions is 12 and full dose is defined as 5 sessions. For Stage-2 E-ACRA, the maximum number of sessions is 8 and full dose is defined as 4 sessions. For Stage-1 ACS, the maximum number of sessions is 8 and full dose is defined as 4 sessions. For Stage-2 ACS, the maximum number of sessions is 4 and full dose is defined as 3 sessions. The definition of full dose was determined by consensus among the investigators.

Participants and Setting

Participants will be youth who are post-adjudication (convicted) and committed to state custody by local juvenile and adult courts recruited from eleven juvenile residential institutions and facilities supervised by the Washington State Department of Children, Youth, and Families Juvenile Rehabilitation (DCYF JR). Eligibility requirements include: 1) aged 15–25 years old 2) are currently incarcerated in DCYF JR and set to release to the community within six months of enrollment, and 3) English or Spanish-speaking. Youth with a current moderate or severe OUD or severe mental health or developmental issues preventing informed consent and/or intervention participation will be excluded. This criterion will be assessed during the consent/assent and baseline process. OUD status is available in the DCYF JR administrative data via the Global Appraisal of Individual Needs (Dennis et al., 2003; Dennis et al., 2004). Initial eligibility will be determined by a DCYF staff member based on DCYF administrative data. This administrator will send information packets with detailed study information, including instructions for opting out of the study, to all eligible youth and their guardians. Study staff will make phone contact with youth who do not opt-out within 14 business days to further explain the study and verify eligibility. Staff at the detention sites will be made aware of the study, and recruiters will coordinate with them to speak with the incarcerated youth.

Consent/assent

We will obtain assent from youth <18 and consent from youth ≥18 and caregivers. For youth who are under state guardianship (i.e. foster youth), we will follow WSIRB procedures including obtaining caseworker permission and providing biological caregivers an informational letter and a 14-day opt-out period for youth for whom parental rights have not been terminated. Because of the potential benefit of the intervention and the minimal risk nature of this study, the WSIRB gave permission during the piloting process for this study to bypass parental consent for youth <18 if there was no response after at least three attempts to contact them so that an unresponsive or absent guardian would not preclude participation.

Strategies for Recruitment and Engagement

We will use several strategies to recruit youth/families, maintain engagement during trial, and retain youth/families during the full assessment period including: 1) Educating staff on purpose/structure of trial and identifying recruitment “champions” at each facility; 2) Mailings to caregivers to explain the study and benefits to them/their youth and encourage participation; 3) Use of A-CRA/ACC and engagement strategies based on motivational interviewing techniques; 4) Provision of refreshments at in-person study activities; 5) Provision of cell phones and unlimited data plan as needed for youth during the intervention and follow-up periods; 6) Financial incentives. Participants across all arms of the trial will receive $30 to complete baseline and release assessments (payment given after both upon release), $20 for 1-month, $50 for 3-month, and $70 for 6-month post-release assessments. In addition, youth will be entered into a lottery to receive an additional $50 for every E-ACRA or ACS session completed (10% chance of winning for every lottery “ticket” received). The latter is a form of contingency management that should be considered an intervention component for future applications to increase motivation to participate in intervention sessions (Biswal, et al., 2024).”

Research Measures

Study measures will be collected at three assessment points: enrollment (baseline), three months post-release, and six months post-release. All research assessments will be conducted by phone individually with a study team member who is blind to condition and will take approximately 90 minutes (baseline) and 30–60 minutes (3-month and 6-month). The primary outcome will be number of days of use of any substance in the past 30 days including opioids, alcohol, and cannabis, and ten other drugs. Secondary outcomes will include frequency of use in the past 30 days of specific substances and recidivism within 90 days. Covariates will include trauma symptoms (PTSD-RI; Steinberg et al., 2013), social support (Berlin Social Support Scale; Schulz & Schwarzer, 2003), emotion regulation (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004), depression (PHQ-9; Kroehke et al., 2001) and anxiety symptoms (GAD-7; Spitzer et al., 2006), as well as youth age, gender, race/ethnicity, caregiver income/highest level of education, and youth highest level of education. Cost analyses data will include direct costs and indirect costs of resources used but not paid for directly (e.g., overhead, participant time) based on the Ingredients Method (Advancing the Power of Economic Evidence, 2016; Levin et al., 2001) and an activities-based costing approach to identify, measure, and value resources (e.g. personnel, materials/supplies, mileage, overhead, participant incurred costs).

Common Measures across the HEAL Prevention Cooperative

A goal of the HEAL Prevention Cooperative (HPC) is to compare intervention efficacy for the initiation, escalation, and severity of opioid misuse. In anticipation of this goal investigators from each study agreed on a set of 26 common measures that would be assessed across all participants (Ridenour et al., 2023). This protocol focuses on primary and secondary outcomes specific to this study, however data collection also includes the HPC common battery.

Sample Size and Power

As is typical for SMART trials, (Almirall et al., 2014) power calculations for this study are based on the two-group planned comparison of the number of days of substance use in the past 90 days at 3-month post-release among youth who were offered Stage-1 E-ACRA vs. youth who were offered Stage-1 ACS. With a sample size of 200 and accounting for potential attrition of up to 20%, we anticipate adequate power (>80%) to detect Rate Ratios of 0.87 for comparing number of days of substance use in E-ACRA compared to ACS. This corresponds to an ability to detect 13% fewer days of use among youth in the E-ACRA intervention.

Statistical Analysis Plan

For our main analysis, we will analyze the effect of Stage-1 intervention condition on substance use outcomes. We will use generalized linear models (GLMs) to compare differences in 3-month and 6-month outcomes among the two interventions that begin with E-ACRA (Table 1: intervention 1 and 2) vs. the two interventions that begin with ACS (Table 1: intervention 3 and 4). Our secondary analyses will evaluate the effects of a) E-ACRA vs. ACS among youth receiving E-ACRA as an initial intervention; and b) E-ACRA vs. ACS among youth who receive ACS as an initial intervention and report problematic substance use 5-weeks post-release.

Cost-effectiveness analysis (CEA)

We will use the incremental cost-effectiveness ratio (ICER) to examine whether the additional investment in interventions that begin with E-ACRA compared to those that begin with ACS is justified by greater impact. We will use activity-based costing to identify, estimate, and value all resources (e.g., personnel, materials, and supplies) used to deliver each intervention (Spacirova et al., 2020). Impacts will be estimated as above, though to ease interpretation we will also use the number of youth in each intervention who achieved the desired outcome as a measure of impact (Hollands et al., 2014; Kuklinski et al., 2023). If we determine that interventions beginning with E-ACRA cost more but have lower impact, we will conclude they are not cost-effective Otherwise, ICERs will be estimated as the difference in costs divided by the difference in effectiveness of the two interventions and interpreted as the incremental cost of achieving a unit gain in the outcome. To determine cost-effectiveness, we will compare ICERs to a range of values indicating willingness to pay (WTP) per unit of outcome (e.g., willingness to pay to reduce one case of opioid misuse) (The White House Office of the Press Secretary, 2017; National Survey on Drug Use and Health, 2017; Murphy et al., 2018). ICERs lower than WTP values will be considered cost-effective. Sensitivity analyses will also be performed, given uncertainty in the measurement of costs and impacts (Kuklinski et al., 2023).

Discussion

Adolescents and young adults in the legal system are vulnerable to opioid use and OUD, making preventive interventions for this population critical (Ducharme et al., 2021). Our goal is to use the SMART study design to identify the optimal intensity and sequencing of components of the A-CRA/ACC interventions to prevent the initiation and escalation of opioid use among youth transitioning from legal facilities to the community. While some prevention interventions yield small effect sizes that diminish over time, others have delayed effects that strengthen over time. This SMART proposes an active second-stage intervention for all participants, affecting our ability to detect delayed effects of the initial interventions. The inclusion of problematic substance use as a tailoring variable in one of the embedded interventions offers a way to identify which youth are engaging in problematic substance use post-release, something we cannot know with certainty apriori, so the subsequent intervention component can be optimally tailored.Varying the intensity and scope of intervention will help focus intervention and resources where they are most needed and may mitigate burden for both institutional staff delivering the intervention, and for youth receiving services. Results from this study will guide intervention development for adolescents and young adults in the legal system. Future studies will evaluate the optimized intervention sequence for efficacy, effectiveness, and implementation in the presence of suitable control conditions.

Funding:

This research was supported by Award UG3DA050189/UH3DA050189 from the National Institute on Drug Abuse (PI: Kym Ahrens and Kevin Haggerty) and K01DA046516 (PI: Ahnalee Brincks). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors have no other relevant financial or non-financial interests to disclose.

Footnotes

Disclosure of Conflicts of Interest: The authors declare that they have no conflict of interest nor competing interests.

This study’s design was pre-registered with clinicaltrials.gov (NCT04901312).

Ethics Approval: This protocol manuscript does not use human subject data and no ethical approval is required. All procedures for the ongoing trial were approved by the Washington State Institutional Review Board prior to study initiation.

Informed Consent: This manuscript does not use human subject data; informed consent is not applicable. All procedures for the ongoing trial, including informed consent, were approved by the Washington State Institutional Review Board prior to study initiation.

CRediT Statements for each author:

Ahnalee M. Brincks, Kym R. Ahrens, Kevin P. Haggerty performed the following: Conceptualization, Methodology, Funding Acquisition, Writing (original and review/editing).

Cari A. McCarty, Margaret R. Kuklinski, and Lexie Kolberg performed the following: Writing (original and review/editing).

Katie M. Albertson, and Ted Ryle, performed the following: Writing (review/editing).

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