Preventing Opioid Use Among Justice-Involved Youth as They Transition to Adulthood: Leveraging Safe Adults (LeSA)
PI: Danica Knight
Project Period: 12/1/19-11/30/24
*This is a joint project with KPICD
Summary: Across the US, substance use (SU) is a significant public health concern, with an estimated 11.1 million misusing prescription opioids. Rates of opioid use disorders (OUDs) have increased exponentially, with 60% of overdoses attributed to heroin and illicit synthetics (such as Fentanyl). Although opioid use among youth is low compared to adults, experimentation and regular use increases later in adolescence as youth transition to adulthood. Juvenile justice (JJ)-involved youth represent a particularly vulnerable population, as they often experience mental health disorders, dysfunctional family/social relationships, and complex trauma, placing them at greater risk for SU and substance use disorders (SUDs). To ensure that these youth do not become another opioid statistic, innovative and effective prevention interventions are needed. We propose to adapt and test an intervention for preventing initiation and/or escalation of opioid misuse among older JJ-involved adolescents. The target enrollment group will be youth aging out of JJ (16-18 years at study enrollment) who are transitioning to their communities after a period of detainment in a secure treatment or correctional facility. Trust-based Relational Intervention® (TBRI®; a relational, attachment-based intervention that promotes emotional regulation through interaction with responsive adults) will be adapted as a prevention intervention targeting youth at risk for SU (especially non-medical use of opioids). Safe adults (e.g., parent/guardian, extended family member) will be trained in behavior management techniques for empowering youth to appropriately express their needs, connecting them with others in pro-social ways, and correcting or reshaping undesirable behavior. The proposed Effectiveness/Implementation study will be conducted in 3 phases. Phase 1 will adapt elements of TBRI for JJ youth, develop intervention manuals and study protocols, examine the acceptability of the adapted intervention, and test the feasibility of the proposed study protocol (e.g., agency and youth recruitment). Feedback from 15 youth/safe adult dyads will be solicited as part of this phase. Phase 2 will examine both the effectiveness of TBRI for preventing opioid misuse and the comparative utility of three support formats: (1) TBRI Training only, (2) TBRI Training + Structured Coaching, or (3) TBRI Training + Responsive Coaching (triggered by the youth’s need/risk). A total of 360 youth/safe adult dyads will be recruited from 6 participating JJ facilities over a 3-year period, and followed for 18 months post-release (20 youth-adult dyads/year per facility). This design enables a comparison of TBRI versus SRP (using a stepped-wedge design where each facility serves as its own control) plus a randomized control trial comparing 3 TBRI support formats. Phase 3 will examine barriers and facilitators of TBRI sustainment. Sixty JJ staff (10 from each agency) will provide input annually via focus groups and surveys. TCU will work with administrators and staff at each JJ facility to implement a sustainment plan, which will include developing in-house TBRI expertise (i.e., staff training and implementation assistance). Successful completion of study aims will provide a test of the adapted intervention and will facilitate sustainment by providing training and implementation support to participating facilities.
Justice Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center
TCU MPIs: Kevin Knight & Danica Knight
Project Period: 7/15/19-4/30/24
Summary: Recognizing the current opioid crisis among justice-involved individuals and the need to intervene at the intersection of justice and community health, the current study proposes to explore positive outcomes associated with a multi-level hybrid implementation approach. The strategy capitalizes on facilitated collaboration (coaching), training, and cross-system data sharing in an effort to leverage improvements in criminal justice and community behavioral health (CBH) interagency collaboration. The ultimate goal of the proposed project is to improve local community public health and safety outcomes for reentering justice-involved individuals who have a history of (or are at risk for) using opioids. Our specific aims are to 1) increase access to and retention in appropriate CBH and medical (MAT) services for reentering justice-involved individuals who have a history of or are at risk for opioid use, 2) improve outcomes (including costs) associated with public health and safety; 3) compare two implementation approaches on systems-level outcomes designed to increase service initiation and receipt with respect to implementation and service outcomes; and 4) examine the impact of these two approaches on justice-involved individual outcomes. The proposed study examines both Implementation and Implementation-Effectiveness, seeking to answer the questions of which implementation strategy (bottom up versus horizontal cascading) is most effective for rapid uptake of evidence-based practices within justice settings. The study also examines which implementation strategy is most effective for increasing service linkage and initiation, services retention, and improved opioid-related public health safety outcomes. A Hybrid Type 3 study design will be used and include a primary aim to compare two implementation strategies and two interventions at two levels (client and system), and a secondary aim to assess client-level outcomes associated with the trial. The study design will integrate 2 robust methodologies (stepped wedge and cluster randomized trial), and will include 18 clinical research performance sites (communities) located in Texas, New Mexico and Illinois. The proposed multi-site JCOIN CRC application includes a highly experienced team of Multiple PIs, investigators, and partners, and will contribute to the JCOIN network in an effort to establish a national consortium of investigators examining promising approaches designed to improve the capabilities and capacity of the justice system to more effectively address the opioid epidemic.
The Substance Use and Health Risk Intervention (SUHRI) for Justice-involved Youth
MPIs: Jennifer Becan & Danica Knight
Project Period: 9/30/19-8/31/22
Summary: This investigation will adapt and pilot test an integrated health risk-reduction and motivational enhancement intervention for Juvenile Justice (JJ) youth that will ultimately be (after full testing through a subsequent large-scale RCT) a sustainable intervention implemented within a JJ supervision/case management context to teach and facilitate positive, prosocial, and expected behaviors. The intervention will use graphical approaches to encourage introspection and problem identification, enhance self-regulation, improve analytical problem-solving skills, and promote healthy behaviors in two inter-related target areas: substance use and risky sex practices. Existing evidence-based intervention materials will be incorporated and delivered through a web-based application. Sessions will be self-directed (require minimal instruction/interaction assistance), and also include a service referral piece whereby youth are provided with a list of treatment and health agencies at the end of sessions that address specific topics. Research activities will be carried out in two pilot studies: (1) Intervention Adaptation and Feasibility and (2) Protocol Feasibility and Preliminary Efficacy Trial. In Pilot 1, intervention content will be adapted from existing evidence-based interventions so that it is developmentally appropriate for the target population and suitable for a web-based format (N = 30; 20 youth, 10 JJ staff). Pilot 2 will test a scaled-down version of an intervention efficacy randomized control trial (RCT), comparing the web-based intervention to a time-matched, information-only group using a 2-arm, randomized design (whereby 120 enrolled youth from one juvenile probation department are randomly assigned to condition). The specific aims of the proposed investigation are to examine intervention feasibility and acceptability, test the feasibility of the study protocol (adherence, subject retention, instrumentation) with JJ-involved youth, and examine the preliminary efficacy of the intervention for addressing health-related behavior change. Proximal outcomes will be improvements in change mechanisms (e.g., problem recognition, decision making, intention to reduce personal risk) and service initiation (SU or STI-related services). Distal outcomes will be reduction in risky behaviors, including substance use (self-report and urinalysis) and sexual health risk (self-reported risky sex practices). Research questions and preliminary hypotheses are specified, and successful completion of the aims will result in an intervention that is appropriate and feasible for use with JJ-involved youth, provide important information regarding feasibility of a full-scale RCT, inform future study design (and a subsequent R01 application), and provide preliminary information regarding the efficacy of the intervention. The study has considerable potential to address an important vulnerable population—justice-involved youth—and focusses on a significant problem—youth behaviors that are self-detrimental and unhealthy.
Increasing Family Engagement and Treatment Initiation Through Family Assessment, Motivation, and Linkage Intervention (FAMLI)
PI: Danica Knight
Project Period: 6/15/19-4/30/22
Summary: The proposed study will integrate existing tools for use with JJ populations and examine the feasibility, acceptability, and preliminary efficacy of a caregiver-youth intervention aimed at increasing SU treatment initiation. The Family Assessment, Motivation, and Linkage Intervention (FAMLI) is an adaptive intervention that incorporates three evidence-based components: 1) assessment of motivation and linkage-related barriers with personalized feedback, 2) Mapping-Enhanced Counseling (MEC) for improving readiness for change and interpersonal communication, and 3) Active Linkage (AL) for addressing logistical barriers to service initiation. Using a Sequential Multiple Assignment Randomized Trial (SMART), 80 youth-caregiver dyads will be randomly assigned to receive an initial dose (2, 1-hr sessions) of either MEC or AL. After 30 days, participants will be classified as Responders (1 or more services initiated) or Non-responders (no service initiation). Responders will receive encouragement to continue SU services, but no further MEC or AL; Non-responders will be randomized to one of two intervening interventions: an additional dose (2, 1-hr sessions) of the initial intervention (MEC or AL) or a different dose (2, 1-hr sessions of the other). The specific aims are to 1) integrate and adapt appropriate evidence-based intervention components as a dyadic intervention approach for JJ youth and caregivers; 2) test the feasibility, acceptability, and optimal configuration of the dyadic intervention components and the protocol used to evaluate effectiveness (including feasibility of recruitment, implementation, measurement); and 3) preliminarily explore a) whether an initial dose of MEC or AL is sufficient for promoting early initiation, b) whether an additional dose of MEC or AL or a change in dose is more effective for Non-responders, and c) which component sequence is most effective for Non-responders. Primary outcomes include youth (initiation of assessment or counseling; counseling attendance) and caregiver (attendance at assessment, first counseling, and/or family sessions) measures. Secondary outcomes include youth and caregiver attitudes (problem recognition, desire for help), normative beliefs (SU norms), perceived control (stressors and obstacles), and youth SU (self-report corroborated by UA results). The proposed study addresses the sizeable gap in service receipt among JJ youth by addressing family engagement, and focuses on improving motivation to change, linkage to services, and treatment engagement.
Telehealth-Clinical Advocacy Project (T-CAP)
PI: Jennifer Pankow
Project Period: 8/1/19-7/31/21
Summary: The opioid crisis has reached epidemic proportions across America. In Illinois, the focus of this application, opioid-related deaths have increased 32% in the past year. As part of a State response, Illinois has launched a police Opioid Diversion Program (ODP), where individuals voluntarily enter the program and ask for help with substance use treatment, without fear of arrest. The proposed Telehealth-Clinical Advocacy Project (T-CAP) intervention focuses on enhancing one Illinois ODP by (1) introducing a telehealth model to link participants to a trained clinician throughout the intervention process and (2) expanding the community treatment services infrastructure (including expanded options for pain management and increased access to medical services that can provide MAT). Volunteer study participants will be randomized to one of two conditions: (1) “treatment as usual” (TAU) comparison group who will meet with a research assistant (RA) to complete surveys at three time points, or (2) T-CAP intervention group who will complete surveys and receive seven telehealth clinical sessions featuring brief intervention services with Motivational Interviewing (MI), “assertive” referrals, and three months of on-going clinical support and advocacy from a clinician. The novelty of this strategy is that it focuses on the need to provide participants with rapidly available professional level clinical services and support as part of the police diversion program, and it expands the service infrastructure to include increased access to MAT and alternative pain management services. The primary study aims are (1) to demonstrate intervention feasibility by measuring study participant receptivity and utilization of the telehealth approach and (2) evaluate the proposed T-CAP measures to assess their performance in gauging the impact telehealth on substance use treatment initiation, short-term treatment retention, and access to other appropriate treatment services for future large-scale research. If the enhancements are feasible, the potential impact of the highly innovative T-CAP intervention will be major. The study’s potential to achieve the larger goal of reducing opioid use and related health problems will have major implications for police diversion policy and practice.
An Implementation Intervention: Mapping Approaches to Prepare for Implementation Transfer (MAP-IT)
PI: Jennifer Becan
Project Period: 9/30/18-8/31/20
Summary: For implementation (and sustainment) of new interventions to be successful, it is critical that barriers are identified and addressed prior to change. It is challenging, however, for agencies to independently assess their own strengths and weaknesses and to develop plans for organizational improvement. Furthermore, the sheer number of strategies to promote implementation makes it difficult for agency leadership to decipher which are most appropriate for their own contexts and needs. This application proposes to develop and pilot test Mapping Approaches to Prepare for Implementation Transfer (MAP-IT), an organizational intervention that includes four key elements: (1) guidelines on forming an implementation workgroup to inform and promote implementation efforts, (2) instruction on mechanisms known to impact implementation, (3) tools and instruction for conducting an agency-driven diagnosis of potential implementation barriers, and (4) tools for developing an implementation blueprint to address identified barriers (including instruction on strategies for addressing potential barriers prior to implementation). The premise of this application is significant in that MAP-IT would provide a low-cost (agency-driven opportunity for deliberate implementation preparedness, without ongoing external coaching) and sustainable (skill development for multiple individuals within the organization that can be applied to future implementation efforts) alternative to promoting organizational adoption of new practices. The specific aims of the proposed research are as follows: Aim 1 – Synergistically integrate and adapt three established implementation intervention tools to promote deliberate agency implementation preparation – organizational assessment and feedback; taxonomy of implementation strategies; and visual-spatial decision making techniques – as combined into a comprehensive training and manualized bundle, MAP-IT. AIM 2 – Conduct a 2-arm cluster randomized efficacy trial of the MAP-IT intervention with 12 substance abuse treatment community-based residential and juvenile justice secure agencies serving adolescents (including those with opioid use disorders) randomized to either MAP-IT (EBP and MAP-IT trainings) or the non-intervention control condition (EBP training only). Successful completion of the aims is expected to (1) establish preliminary evidence for the efficacy of a low-cost, sustainable alternative for improving implementation preparation that agencies can use to support and expedite implementation transfer, (2) shift the current paradigm by encouraging researchers (designing uptake studies) and health care agencies (independently striving to implement new practices) to place greater emphasis on pre-implementation preparations for change, (3) provide an empirical examination of how exploration and preparation can support implementation, using established measurement platforms and theoretical frameworks, and (4) provide documentation of agency selection of implementation strategies for promoting change in real-world settings. Findings from the proposed R21 will inform intervention effectiveness testing and implementation strategy selection in a future R01 aimed at improving uptake of best practices within behavioral healthcare delivery services using a full-scale randomized control trial.