Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths.

BACKGROUND: Evidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices. METHODS: In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults. RESULTS: During the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year. CONCLUSIONS: In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).

"Wanna cry this out real quick?": an examination of secondary traumatic stress risk and resilience among post-overdose outreach staff in Massachusetts.

BACKGROUND: Post-overdose outreach programs engage overdose survivors and their families soon after an overdose event. Staff implementing these programs are routinely exposed to others' trauma, which makes them vulnerable to secondary traumatic stress (STS) and compassion fatigue. The purpose of this study was to explore experiences of STS and associated upstream and downstream risk and protective factors among program staff. METHODS: We conducted a post-hoc analysis of semi-structured interviews with post-overdose outreach program staff in Massachusetts. Transcripts were analyzed using a multi-step hybrid inductive-deductive approach to explore approaches and responses to outreach work, factors that might give rise to STS, and compassion fatigue resilience. Findings were organized according to the three main constructs within Ludick and Figley's compassion fatigue resilience model (empathy, secondary traumatic stress, and compassion fatigue resilience). RESULTS: Thirty-eight interviews were conducted with staff from 11 post-overdose outreach programs in Massachusetts. Within the empathy construct, concern for others' well-being emerged as a motivator to engage in post-overdose outreach work - with staff trying to understand others' perspectives and using this connection to deliver respectful and compassionate services. Within the secondary traumatic stress construct, interviewees described regular and repeated exposure to others' trauma - made more difficult when exposures overlapped with staff members' personal social spheres. Within the compassion fatigue resilience construct, interviewees described the presence and absence of self-care practices and routines, social supports, and workplace supports. Job satisfaction and emotional detachment from work experiences also arose as potential protective factors. Interviewees reported inconsistent presence and utilization of formal support for STS and compassion fatigue within their post-overdose outreach teams. CONCLUSION: Post-overdose outreach program staff may experience secondary traumatic stress and may develop compassion fatigue, particularly in the absence of resilience and coping strategies and support. Compassion fatigue resilience approaches for post-overdose outreach staff warrant further development and study.

Initiation of HIV pre-exposure prophylaxis among youth in the United States, 2015-2018.

Adolescents and young adults ("youth") account for one-fifth of new HIV diagnoses in the U.S. HIV pre-exposure prophylaxis (PrEP), which became FDA approved in adolescents in May 2018, is highly effective at preventing HIV infection though there are limited data for PrEP initiation in youth. We aimed to quantify PrEP initiation and identify factors associated with PrEP initiation among youth at risk for HIV. We conducted a retrospective cohort study of youth aged 13-26 years who had an indication for PrEP between 1 January 2015, and 31 December 2018. We used data on commercially insured US individuals from the IBM MarketScan Commercial Database. We compared factors among youth who did and did not receive PrEP. We developed a multivariable logistic regression model to identify the association of all study covariates with receipt of PrEP. Among potentially PrEP eligible youth, only 2171 (1.6%) received a PrEP prescription in the year following their PrEP eligible claim. In multivariable models, youth who received PrEP were more likely to be older (adjusted odd ratio [aOR] for 18-20 year olds = 5.11; 95% CI = 3.35-7.77; aOR for 21-26 year olds = 16.90; 95% CI = 11.0-24.7), male (aOR = 92.42; 95% CI = 68.24-125), have sexual activity with elevated risk (aOR = 7.47; 95% CI = 6.50-8.60), or be diagnosed with gonorrhea or syphilis than youth who did not receive PrEP. Our findings highlight an opportunity to improve HIV prevention early in the life course.

"My Life Isn't Defined by Substance Use": Recovery Perspectives Among Young Adults with Substance Use Disorder.

BACKGROUND: While substance use disorder remains a leading cause of morbidity and mortality for young adults, low rates of treatment engagement and retention persist. One explanation is that substance use disorder treatment approaches do not match young adults' expectations for recovery. While the concept of recovery has been explored among adult populations, less is known about how young adults think about recovery. OBJECTIVE: To describe perspectives of recovery among young adults with substance use disorder. DESIGN: Qualitative, in-depth interviews exploring young adults' definitions of recovery. PARTICIPANTS: Twenty English-speaking young adults (7 women; 21-29 years old) diagnosed with substance use disorder recruited from an urban safety net hospital in Massachusetts. APPROACH: Interviews were recorded and transcribed verbatim. An iterative categorization analytic approach was used to identify and interpret themes. KEY RESULTS: Four themes related to recovery were identified. First, young adults described recovery as a way to grow up and live a normal life not defined by the substance use. A second theme was recovery had to include multiple components, such as mental health treatment, to be successful. Third, young adults described recovery as a self-motivated process, and it was important that young adults had agency in recovery decision-making. Fourth, recovery was described as a lifelong pursuit that required vigilance and commitment. CONCLUSIONS: In this qualitative study of young adults with substance use disorder, participants identified themes that have implications for treatment models. Participants recognized recovery as a complex and individually motivated process that includes multiple components such as mental health treatment and re-engagement in regular daily activities. Models of care for young adults should consider incorporating these treatment elements to improve engagement and retention.

Association of multidisciplinary education and research in substance use and addiction's (AMERSA) 2021 transforming care through evidence and policy conference: Tackling stigma and giving voice to lived experience.

This commentary provides an overview of the Association of Multidisciplinary Education and Research in Substance use and Addiction (AMERSA) 2021 annual conference: Transforming Care Through Evidence and Policy. The topics covered during the conference were especially critical given the unprecedented rise in drug overdose deaths and continued impact of the COVID-19 pandemic on substance use and addiction. The importance of tackling stigma and ensuring that we partner with those with lived experience to have maximal impact was highlighted.

Integrating Harm Reduction into Outpatient Opioid Use Disorder Treatment Settings : Harm Reduction in Outpatient Addiction Treatment.

Opioid use disorder (OUD) is increasingly recognized as a chronic, relapsing brain disease whose treatment should be integrated into primary care settings alongside other chronic conditions. However, abstinence from all non-prescribed substance use continues to be prioritized as the only desired goal in many outpatient, primary care-based treatment programs. This presents a barrier to engagement for patients who continue to use substances and who may be at high risk for complications of ongoing substance use such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), superficial and deep tissue infections, and overdose. Harm reduction aims to reduce the negative consequences of substance use and offers an alternative to abstinence as a singular goal. Incorporating harm reduction principles into primary care treatment settings can support programs in engaging patients with ongoing substance use and facilitate the delivery of evidence-based screening and prevention services. The objective of this narrative review is to describe strategies for the integration of evidence-based harm reduction principles and interventions into outpatient, primary care-based OUD treatment settings. We will offer specific tools for providers and programs including strategies to support safer injection practices, assess the risks and benefits of continuing medications for opioid use disorder in the setting of ongoing substance use, promote a non-stigmatizing program culture, and address the needs of special populations with ongoing substance use including adolescents, parents, and families.

Characteristics and Receipt of Medication Treatment Among Young Adults Who Experience a Nonfatal Opioid-Related Overdose.

STUDY OBJECTIVE: Nonfatal opioid overdose represents an opportunity to engage young adults into using medication for opioid use disorder. We seek to describe characteristics of young adults who experience nonfatal overdose and estimate rates of and time to medication for opioid use disorder for young adults relative to those aged 26 to 45 years. METHODS: We conducted a cohort study using retrospective administrative data of 15,281 individuals aged 18 to 45 years who survived an opioid-related overdose in Massachusetts between 2012 and 2014, using deidentified, individual-level, linked data sets from Massachusetts government agencies. We described patient characteristics stratified by age (18 to 21, 22 to 25, and 26 to 45 years) and evaluated multivariable Cox proportional hazards models to compare rates of medication for opioid use disorder receipt, controlling for age, sex, history of mental health disorders, and addiction treatment. RESULTS: Among 4,268 young adults in the year after nonfatal overdose, 28% (n=336/1,209) of those aged 18 to 21, 36% (n=1,097/3,059) of those aged 22 to 25 years, and 36% (n=3,916/11,013) of those aged 26 to 45 years received medication for opioid use disorder. For individuals aged 18 to 21 and 22 to 25 years, median time to buprenorphine treatment was 4 months (interquartile range 1.7 to 1.8 months); to methadone treatment, 4 months (interquartile range 2.8 to 2.9 months); and to naltrexone treatment, 1 month (interquartile range 1 to 1 month). Individuals aged 18 to 21 years were less likely (adjusted hazard ratio 0.60 [95% confidence interval 0.45 to 0.70]) to receive methadone than those aged 22 to 25 and 26 to 45 years. Individuals aged 18 to 21 years and those aged 22 to 25 years were more likely to receive naltrexone (adjusted hazard ratio 1.65 [95% confidence interval 1.36 to 2.00] and 1.41 [95% confidence interval 1.23 to 1.61], respectively) than those aged 26 to 45 years. CONCLUSION: One in 3 young adults received medication for opioid use disorder in the 12 months after surviving an overdose. Type of medication for opioid use disorder received appeared to be age associated. Future research should focus on how medication choice is made and how to optimize the emergency department for medication for opioid use disorder initiation after nonfatal overdose.

A scoping review of post opioid-overdose interventions.

INTRODUCTION: Nonfatal opioid overdose is a significant risk factor for subsequent fatal overdose. The time after a nonfatal overdose may provide a critical engagement opportunity to both reduce subsequent overdose risk and link individuals to treatment. Post-overdose interventions have emerged in affected communities throughout the United States (US). The objective of this scoping review is to identify US-based post-overdose intervention models (1) described in peer-reviewed literature and (2) implemented in public health and community settings. METHODS: Using the adapted PRISMA Checklist for Scoping Reviews, we searched PubMed, PsychInfo, Academic OneFile, and federal and state databases for peer-reviewed and gray literature descriptions of post-overdose programs. We developed search strings with a reference librarian. We included studies or programs with at least the following information available: name of program, description of key components, intervention team, and intervention timing. RESULTS: We identified a total of 27 programs, 3 from the peer-reviewed literature and 24 from the gray literature. 9 programs operated out of the ED, while 18 programs provided post-overdose support in other ways: through home or overdose location visits, mobile means, or as law enforcement diversion. Commonly, they include partnerships among public safety and community service providers. CONCLUSIONS: Programs are emerging throughout the US to care for individuals after a nonfatal opioid overdose. There is variability in the timing, components, and follow-up in these programs and little is known about their effectiveness. Future work should focus on evaluation and testing of post-overdose programs so that best practices for care can be implemented.

Medication for Opioid Use Disorder After Nonfatal Opioid Overdose and Association With Mortality: A Cohort Study.

Background: Opioid overdose survivors have an increased risk for death. Whether use of medications for opioid use disorder (MOUD) after overdose is associated with mortality is not known. Objective: To identify MOUD use after opioid overdose and its association with all-cause and opioid-related mortality. Design: Retrospective cohort study. Setting: 7 individually linked data sets from Massachusetts government agencies. Participants: 17 568 Massachusetts adults without cancer who survived an opioid overdose between 2012 and 2014. Measurements: Three types of MOUD were examined: methadone maintenance treatment (MMT), buprenorphine, and naltrexone. Exposure to MOUD was identified at monthly intervals, and persons were considered exposed through the month after last receipt. A multivariable Cox proportional hazards model was used to examine MOUD as a monthly time-varying exposure variable to predict time to all-cause and opioid-related mortality. Results: In the 12 months after a nonfatal overdose, 2040 persons (11%) enrolled in MMT for a median of 5 months (interquartile range, 2 to 9 months), 3022 persons (17%) received buprenorphine for a median of 4 months (interquartile range, 2 to 8 months), and 1099 persons (6%) received naltrexone for a median of 1 month (interquartile range, 1 to 2 months). Among the entire cohort, all-cause mortality was 4.7 deaths (95% CI, 4.4 to 5.0 deaths) per 100 person-years and opioid-related mortality was 2.1 deaths (CI, 1.9 to 2.4 deaths) per 100 person-years. Compared with no MOUD, MMT was associated with decreased all-cause mortality (adjusted hazard ratio [AHR], 0.47 [CI, 0.32 to 0.71]) and opioid-related mortality (AHR, 0.41 [CI, 0.24 to 0.70]). Buprenorphine was associated with decreased all-cause mortality (AHR, 0.63 [CI, 0.46 to 0.87]) and opioid-related mortality (AHR, 0.62 [CI, 0.41 to 0.92]). No associations between naltrexone and all-cause mortality (AHR, 1.44 [CI, 0.84 to 2.46]) or opioid-related mortality (AHR, 1.42 [CI, 0.73 to 2.79]) were identified. Limitation: Few events among naltrexone recipients preclude confident conclusions. Conclusion: A minority of opioid overdose survivors received MOUD. Buprenorphine and MMT were associated with reduced all-cause and opioid-related mortality. Primary Funding Source: National Center for Advancing Translational Sciences of the National Institutes of Health.

Treatments Used Among Adolescent Residential Addiction Treatment Facilities in the US, 2022.

This study surveyed US adolescent residential addiction treatment facilities to assess treatments used for adolescents younger than 18 years seeking treatment for opioid use disorder.

Overdose Education and Naloxone Rescue Kits for Family Members of Individuals Who Use Opioids: Characteristics, Motivations, and Naloxone Use.

BACKGROUND: In response to the overdose epidemic, a network of support groups for family members in Massachusetts has been providing overdose education and naloxone rescue kits (OEN). The aims of this study were to describe the characteristics, motivations, and benefits of family members who receive OEN and to describe the frequency of naloxone used during an overdose rescue. METHODS: This cross-sectional, multisite study surveyed attendees of community support groups for family members of opioid users where OEN training was offered using a 42-item self-administered survey that included demographics, relationship to the individual using opioids, experience with overdose, motivations to receive OEN, and naloxone rescue kit use. RESULTS: Of 126 attendees who completed surveys at 8 sites, most attendees were white (95%), female (78%), married or partnered (74%), parents of an individual using opioids (85%), and providing financial support for the individual using opioids (52%). The OEN trainees (79%) were more likely than attendees not trained (21%) to be parents of an individual using opioids (91% vs. 65%, P < .05), to provide financial support to an individual using opioids (58% vs. 30%, P < .05), and to have witnessed an overdose (35% vs. 12%, P = .07). The major motivations to receive training were wanting a kit in their home (72%), education provided at the meeting (60%), and hearing about benefits from others (57%). Sixteen parents reported witnessing their child overdose, and 5 attendees had used naloxone successfully during an overdose rescue. CONCLUSIONS: Support groups for families of people who use opioids are promising venues to conduct overdose prevention trainings because attendees are motivated to receive training and will use naloxone to rescue people when witnessing an overdose. Further study is warranted to understand how to optimize this approach to overdose prevention in the community setting.

Caring for Hospitalized Adults With Opioid Use Disorder in the Era of Fentanyl: A Review.

Importance: The rise of fentanyl and other high-potency synthetic opioids across US and Canada has been associated with increasing hospitalizations and unprecedented overdose deaths. Hospitalization is a critical touchpoint to engage patients and offer life-saving opioid use disorder (OUD) care when admitted for OUD or other medical conditions. Observations: Clinical best practices include managing acute withdrawal and pain, initiating medication for OUD, integrating harm reduction principles and practices, addressing in-hospital substance use, and supporting hospital-to-community care transitions. Fentanyl complicates hospital OUD care. Fentanyl's high potency intensifies pain, withdrawal, and cravings and increases the risk for overdose and other harms. Fentanyl's unique pharmacology has rendered traditional techniques for managing opioid withdrawal and initiating buprenorphine and methadone inadequate for some patients, necessitating novel strategies. Further, co-use of opioids with stimulants drugs is common, and the opioid supply is unpredictable and can be contaminated with benzodiazepines, xylazine, and other substances. To address these challenges, clinicians are increasingly relying on emerging practices, such as low-dose buprenorphine initiation with opioid continuation, rapid methadone titration, and the use of alternative opioid agonists. Hospitals must also reconsider conventional approaches to in-hospital substance use and expand clinicians' understanding and embrace of harm reduction, which is a philosophy and set of practical strategies that supports people who use drugs to be safer and healthier without judgment, coercion, or discrimination. Hospital-to-community care transitions should ensure uninterrupted access to OUD care after discharge, which requires special consideration and coordination. Finally, improving hospital-based addiction care requires dedicated infrastructure and expertise. Preparing hospitals across the US and Canada to deliver OUD best practices requires investments in clinical champions, staff education, leadership commitment, community partnerships, quality metrics, and financing. Conclusions and Relevance: The findings of this review indicate that fentanyl creates increased urgency and new challenges for hospital OUD care. Hospital clinicians and systems have a central role in addressing the current drug crisis.

Medications for Opioid Use Disorder for Youth: Patient, Caregiver, and Clinician Perspectives.

PURPOSE: Clinical trial data support use of medications for opioid use disorder (MOUD) in adolescents and young adults ("youth"), but qualitative data are lacking on the acceptability and importance of MOUD to youth, caregivers, and clinicians. We assessed how these stakeholders viewed the role of MOUD in treatment and recovery. METHODS: We recruited youth aged from 15 to 25 years with opioid use disorder who had received buprenorphine, naltrexone, or methadone and caregivers from a primary care-based youth addiction treatment program. We also recruited clinicians with addiction expertise from social work, nursing, pediatrics, internal medicine, and psychiatry. We conducted semistructured interviews assessing special considerations for MOUD use in youth. Three coders performed inductive and deductive thematic analysis of transcripts. RESULTS: Among 37 participants, including 15 youth (age range, 17-25 years), nine caregivers, and 13 clinicians, we identified three themes. (1) Medications support recovery in the short term: Youth described MOUD as beneficial in managing withdrawal symptoms. Notably, some youth and caregivers preferred to limit MOUD duration. (2) Medication adherence is affected by type of medication, dosing regimen, and route of administration. Participants endorsed long-acting, injectable MOUD for ease of use and youth's ability to continue engagement in "normal activities" without daily medication. (3) Caregiver involvement can support medication decisions and adherence. Youth and some clinicians described the need to assess caregiver involvement before incorporating them into treatment; caregivers and other clinicians described caregivers as critical in supporting accountability. DISCUSSION: MOUD is evidence-based, and its provision should be developmentally responsive and youth- and family-centered, incorporating caregivers when appropriate.

"If you're strung out and female, they will take advantage of you": A qualitative study exploring drug use and substance use service experiences among women in Boston and San Francisco.

BACKGROUND: Significant disparities in substance use severity and treatment persist among women who use drugs compared to men. Thus, we explored how identifying as a woman was related to drug use and treatment experiences. METHODS: The study recruited participants for a qualitative interview study in Boston and San Francisco from January-November 2020. Self-identified women, age ≥ 18 years, with nonprescribed opioid use in the past 14 days were eligible for inclusion. The study team developed deductive codes based on intersectionality theory and inductive codes generated from transcript review, and identified themes using grounded content analysis. RESULTS: The study enrolled thirty-six participants. The median age was 46; 58 % were White, 16 % were Black, 14 % were Hispanic, and 39 % were unstably housed. Other drug use was common with 81 % reporting benzodiazepine, 50 % cocaine, and 31 % meth/amphetamine use respectively. We found that gender (i.e., identifying as a woman) intersected with drug use and sex work practices and exacerbated experiences of marginalization. Violence was ubiquitous in drug use environments. Some women reported experiences of gender-based violence in substance use service settings that perpetuated cycles of trauma and reinforced barriers to care. Substance use services that were women-led, safe, and responsive to women's needs were valued and sought after. CONCLUSION: Women reported a cycle of trauma and drug use exacerbated by oppression in substance use services settings. In addition to increasing access to gender-responsive care, our study highlights the need for greater research and examination of practices within substance use service settings that may be contributing to gender-based violence.

Adolescent Residential Addiction Treatment In The US: Uneven Access, Waitlists, And High Costs.

Drug overdose deaths among adolescents are increasing in the United States. Residential treatment facilities are one treatment option for adolescents with substance use disorders, yet little is known about their accessibility or cost. Using the Substance Abuse and Mental Health Services Administration's treatment locator and search engine advertising data, we identified 160 residential addiction treatment facilities that treated adolescents with opioid use disorder as of December 2022. We called facilities while role-playing as the aunt or uncle of a sixteen-year-old child with a recent nonfatal overdose, to inquire about policies and costs. Eighty-seven facilities (54.4 percent) had a bed immediately available. Among sites with a waitlist, the mean wait time for a bed was 28.4 days. Of facilities providing cost information, the mean cost of treatment per day was $878. Daily costs among for-profit facilities were triple those of nonprofit facilities. Half of facilities required up-front payment by self-pay patients. The mean up-front cost was $28,731. We were unable to identify any facilities for adolescents in ten states or Washington, D.C. Access to adolescent residential addiction treatment centers in the United States is limited and costly.

Privacy and confidentiality in Massachusetts' post-overdose outreach programs: Mixed methods analysis of outreach staff surveys and interviews.

BACKGROUND: Public health-public safety partnerships for post-overdose outreach have emerged in many communities to prevent future overdose events. These efforts often identify overdose survivors through emergency call data and seek to link them with relevant services. The aim of this study was to describe how post-overdose outreach programs in Massachusetts manage the confidentiality of identifiable information and privacy of survivors. METHODS: In 2019, 138 Massachusetts programs completed surveys eliciting responses to questions about program operations. Descriptive statistics were calculated from the closed-ended survey responses. Thirty-eight interviews were conducted among outreach staff members during 2019-2020. Interview transcripts and open-ended survey responses were thematically analyzed using deductive and inductive approaches. RESULTS: Of programs that completed the survey, 90 % (n = 124/138) reported acting to protect the privacy of survivors following overdose events, and 84 % (n = 114/135) reported implementing a protocol to maintain the confidentiality of personal information. Interviews with outreach team members indicated substantial variation in practice. Outreach programs regularly employed discretion in determining actions in the field, sometimes undermining survivor privacy and confidentiality (e.g., by disclosing the overdose event to family members). Programs aiming to prioritize privacy and confidentiality attempted to make initial contact with survivors by phone, limited or concealed materials left behind when no one was home, and/or limited the number of contact attempts. CONCLUSIONS: Despite the establishment of privacy and confidentiality protocols within most post-overdose outreach programs, application of these procedures was varied, discretionary, and at times viewed by staff as competing with engagement efforts. Individual outreach overdose teams should prioritize privacy and confidentiality during outreach to protect overdose survivors from undesired exposure. In addition to individual program changes, access to overdose survivor information could be changed across all programs to bolster privacy and confidentiality protocols. For example, transitioning the management of overdose-related information to non-law enforcement agencies would limit officers' ability to disseminate such information at their discretion.

Standard Versus Family-Based Screening, Brief Intervention, and Referral to Treatment for Adolescent Substance Use in Primary Care: Protocol for a Multisite Randomized Effectiveness Trial.

BACKGROUND: Screening, brief intervention, and referral to treatment for adolescents (SBIRT-A) is widely recommended to promote detection and early intervention for alcohol and other drug (AOD) use in pediatric primary care. Existing SBIRT-A procedures rely almost exclusively on adolescents alone, despite the recognition of caregivers as critical protective factors in adolescent development and AOD use. Moreover, controlled SBIRT-A studies conducted in primary care have yielded inconsistent findings about implementation feasibility and effects on AOD outcomes and overall developmental functioning. There is urgent need to investigate the value of systematically incorporating caregivers in SBIRT-A procedures. OBJECTIVE: This randomized effectiveness trial will advance research and scope on SBIRT-A in primary care by conducting a head-to-head test of 2 conceptually grounded, evidence-informed approaches: a standard adolescent-only approach (SBIRT-A-Standard) versus a more expansive family-based approach (SBIRT-A-Family). The SBIRT-A-Family approach enhances the procedures of the SBIRT-A-Standard approach by screening for AOD risk with both adolescents and caregivers; leveraging multidomain, multireporter AOD risk and protection data to inform case identification and risk categorization; and directly involving caregivers in brief intervention and referral to treatment activities. METHODS: The study will include 2300 adolescents (aged 12-17 y) and their caregivers attending 1 of 3 hospital-affiliated pediatric settings serving diverse patient populations in major urban areas. Study recruitment, screening, randomization, and all SBIRT-A activities will occur during a single pediatric visit. SBIRT-A procedures will be delivered digitally on handheld tablets using patient-facing and provider-facing programming. Primary outcomes (AOD use, co-occurring behavior problems, and parent-adolescent communication about AOD use) and secondary outcomes (adolescent quality of life, adolescent risk factors, and therapy attendance) will be assessed at screening and initial assessment and 3-, 6-, 9-, and 12-month follow-ups. The study is well powered to conduct all planned main and moderator (age, sex, race, ethnicity, and youth AOD risk status) analyses. RESULTS: This study will be conducted over a 5-year period. Provider training was initiated in year 1 (December 2023). Participant recruitment and follow-up data collection began in year 2 (March 2024). We expect the results from this study to be published in early 2027. CONCLUSIONS: SBIRT-A is widely endorsed but currently underused in pediatric primary care settings, and questions remain about optimal approaches and overall effectiveness. In particular, referral to treatment procedures in primary care remains virtually untested among youth. In addition, whereas research strongly supports involving families in interventions for adolescent AOD, SBIRT-A effectiveness trial testing approaches that actively engage family members in primary care are absent. This trial is designed to help fill these research gaps to inform the critical health decision of whether and how to include caregivers in SBIRT-A activities conducted in pediatric primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05964010; https://www.clinicaltrials.gov/study/NCT05964010. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54486.