Background Characterizing pharmacies based on their practices, community need for such practices and pharmacy type could advance pharmacy-based intervention precision to reinforce or increase pharmacy practices related to reducing opioid overdose deaths. Objective To measure a combination of 3 pharmacy practices focused on opioid overdose death reduction and explore whether there are discernable groupings related to practices, pharmacy characteristics, and community characteristics. Methods A telephone survey was conducted between August 1, 2023 and October 8, 2023 with the pharmacist on duty at 921 Arizona community pharmacies. The survey measured pharmacy characteristics, buprenorphine stocking, buprenorphine and naltrexone dispensing, likelihood of methadone dispensing for opioid use disorder (OUD) when legally permitted, and interest in state-subsidized naloxone dispensing. Results A response rate of 22.6% was achieved (N = 208). The vast majority (93.8%) of pharmacies stocked buprenorphine and dispensed buprenorphine or naltrexone. About half (47.6%) were very likely or somewhat likely to dispense methadone for OUD when permitted. Metropolitan pharmacies were less likely to dispense methadone compared to rural pharmacies (45.1% Vs. 75.0%). Among pharmacies not likely to dispense methadone, 85.3% were located in counties with opioid overdose death rates above the national average. About half of pharmacies indicated interest in enrolling as a distributor of state-subsidized naloxone. When considered together as pharmacy practices, 26% of pharmacies reported frequent buprenorphine or naltrexone dispensing, expressed interest in subsidized naloxone dispensing and a likelihood of methadone dispensing. Latent class analysis yielded 4 distinct groups of pharmacies ranging from those only dispensing buprenorphine or naltrexone frequently to adopters of the 3 pharmacy practices related to opioid overdose reduction in the community. The ‘adopters’ who frequently dispensed buprenorphine or naltrexone, who had interest in subsidized naloxone, and would likely dispense methadone for OUD tended to be in metropolitan or small/rural areas but tended not to be mass merchandizers. Conclusion An emerging group of pharmacies shows potential for greater adoption of pharmacy practices to reduce opioid overdose. Larger, multistate studies will help verify pharmacy latent class groups for greater precision of pharmacy practice interventions to reduce opioid overdose in communities. It is crucial to explore why pharmacies in higher need counties are not likely to adopt practices related to opioid overdose reduction.

Pediatric patients with chronic pain are at risk for long- term opioid addiction as adults, have limited pediatric treatment options, and commonly experience barriers to developmentally appropriate recreation, leisure, and play opportunities. Interdisciplinary approaches to creating evidence-based therapeutic programs for this population are called for in the literature yet few exist. This qualitative study examines the Kids B.E.A.R. Pain Protocol, an interdisciplinary approach created by professionals in public health, child psychology, and recreational therapy healthcare fields. The major overarching theme of psychosocial support emerged after analyzing semi-structured interviews with adolescent patients, parents, and staff associated with the Kids B.E.A.R. Pain Protocol. Four corresponding subthemes were present including: 1) enhanced social networks, 2) giving and receiving support, 3) inclusive and normalizing nature of the intervention, and 4) social comparisons with similar others. Preliminary qualitative evidence supports the continued implementation of this interdisciplinary Kids B.E.A.R. Pain Protocol with future research needed to better understand the generalizability of a wider patient population.

This study examined and compared the effects of applied behavior analysis treatments in conjunction with therapeutic horseback riding (THR) and the improvement of social skills in children with autism spectrum disorder (ASD). The research study compared the effectiveness of behavior management approaches during three conditions (THR, THR with token reinforcement, and THR with visual cues) using a single-subject research design to determine the “best treatment” for improving receptive social skills among children with ASD (N=4). During the comparison phase, the researcher determined the frequency rate of receptive social skills among each condition to determine the most effective approach in facilitating observed social skills. While results of this study indicated that all three conditions were effective, token reinforcement used in conjunction with THR was the most effective in producing the highest frequency rate of receptive social communications.

Pharmacies have the opportunity to implement multiple strategies to prevent nonmedical prescription opioid use and associated harms, including implementing disposal programs (e.g., disposal boxes, deactivation products, and mail-back envelopes) and offering over-the-counter naloxone. The quantity of opioid prescriptions dispensed in the United States (US) is so high that every other person could receive one opioid prescription. Many of these opioids go unused and are kept in homes rather than disposed after ceasing use. The primary source of prescription opioids for nonmedical use is relatives or friends, which suggests that the diversion of excess and retained prescription opioids contributes significantly to nonmedical use and associated consequences. Naloxone is a life-saving medication that works as an opioid antagonist to reverse the effects of mu-agonist opioids and restore normal breathing to a person experiencing an overdose. To increase access to naloxone, all 50 US states have passed laws (e.g., statewide standing orders) that allow pharmacists to distribute naloxone without an individual patient prescription. Additionally, the US Food and Drug Administration (FDA) approved the first over-the-counter naloxone medication in March of 2023. Socioeconomic disparities are associated with nonmedical opioid use and its related harms. To prevent exacerbating these existing health disparities, it is essential to implement pharmacy-based harm reduction practices equitably. The overall objective is to assess the extent to which disposal programs and same-day naloxone have been implemented in pharmacies across the US and examine place-based health disparities in implementation. We hypothesize that as neighborhood disadvantage and the proportion of Black/African American residents in a neighborhood increase, the likelihood of a pharmacy having a disposal program or same-day naloxone decreases. We also hypothesize differences in medication disposal programs and same-day naloxone availability by retailer chain and type of pharmacy. A secret shopper caller protocol will be used to identify pharmacies that have implemented a medication disposal program and have naloxone available on the same day without a prescription. We will conduct disproportionate stratified random sampling with the strata being pharmacy chains to maximize the likelihood of sampling diverse corporations and independent pharmacies. The goal is to obtain a final sample of 1,000 pharmacies. Neighborhood sociodemographic characteristics will be appended to the secret shopper data. To explore neighborhood and pharmacy characteristics associated with the availability of medication disposal programs and same-day naloxone, we will use logistic regression. This protocol represents the entire structure of the secret shopper caller approach. Ethical approval for the study has been obtained and data collection will be completed in 2024. This will be the first study to examine national estimates of medication disposal programs and same-day naloxone availability at pharmacies and geographic disparities associated with implementation. N/A

BackgroundThe number of overdose deaths in the United States involving opioids continues to exceed 100,000 per year. This has precipitated ongoing declarations of a public health emergency. Harm reduction approaches, such as promoting awareness of, ensuring access to, and fostering willingness to use naloxone to reverse opioid overdose, are a key component of a larger national strategy to address the crisis. In addition, overdose reversal with naloxone directly and immediately saves lives. Because of pharmacies’ ubiquity and pharmacists’ extensive clinical training, community pharmacies are well-positioned, in principle, to facilitate naloxone access and education. ObjectiveIn 2022, a single-site pilot study of PharmNet, a community pharmacy intervention incorporating naloxone distribution, awareness building, and referral, showed promising outcomes for both naloxone and resource distribution in the community. As a next step, this study was intended to be a pilot randomized controlled trial of PharmNet in 7 pharmacies. However, due to circumstances outside of the study team’s control, data collection was unable to be fully completed as planned. In keeping with open research standards, we transparently report all available data from the study and discuss trial barriers and processes. We do so both to provide insights that may inform similar studies and to avoid the “file-drawer” (publication bias) problem, which can skew the aggregated scholarly literature through nonpublication of registered trial results or selective publication of findings affirming authors’ hypotheses. MethodsThis paper reports an in-depth implementation study assessment, provides the available observational data, and discusses implementation considerations for similar studies in independent (eg, nonchain) community pharmacies. ResultsRetrospective assessment of study outcomes and fidelity data provided for robust discussion around how resource differences in independent community pharmacies (vs well-resourced chain pharmacies), as well as high demands on staff, can affect intervention implementation, even when leadership is highly supportive. ConclusionsCommunity pharmacies, particularly independent community pharmacies, may require more support than anticipated to be successful when implementing a new intervention into practice, even if it might affect estimates of real-world effectiveness. Further implementation science research is needed specific to independent community pharmacies. All study elements are outlined in the International Registered Report Identifier (IRRID) PRR1-10.2196/42373. Although this paper reports results associated with that registration, results and conclusions should not be given the weight assigned to findings from a preregistered study. International Registered Report Identifier (IRRID)RR2-10.2196/42373

Autism Spectrum Disorder (ASD) is a developmental disorder that affects an individual's ability to communicate, create social relationships, and regulate sensory input and repetitive behaviors. An uncommon intervention used in ASD treatment is farm animal- assisted therapy (AAT). AAT interventions focus on the use of animals in adjunct to achieve goals and outcomes. Farm AAT is defined as the use of farm animals such as cows, sheep, goats, horses, and pigs in AAT interventions. There is a lack of evidence on the use of farm animals and their benefits within the scope of AAT and in recreational therapy. The purpose of this study was to provide evidence, from the perspective of parents, of the potential benefits of farm AAT as a recreational therapy intervention for individuals with ASD. Data collection using a semi-structured interview guide was conducted over the phone with parents who participated in family session programs at the study location. Five participants were selected who matched the inclusion criteria for this study. The findings from this study reported that there were increases in social behaviors, regulation of behaviors, and a sense of normalcy for the children. The findings from this study provide a foundation for future research related to farm AAT such as evidenced-based curriculums and practices. The data provide therapists and parents with an understanding of the potential benefits that are gained from participation in farm AAT interventions.

Background: Pharmacy-based medication disposal programs is one approach to prevent diversion of unused prescription opioids. Objective(s): The objective of this study was to assess the extent to which disposal programs have been implemented by retail pharmacies and identify determinants of implementation using the Consolidated Framework for Implementation Research. Methods: A sequential mixed-method design was used to examine implementation of medication disposal programs at pharmacies in Pitt County, NC. We conducted environmental scans of all retail pharmacies that served community members (N = 31) to assess the extent to which disposal programs had been implemented. Then, we conducted interviews with pharmacists (n = 15; 48.4%) to identify determinants of implementation. The following pharmacy types were represented in the completed interviews: corporate chain (n = 10), small chain (n = 1), independently owned and operated (n = 1), medical (n = 2), and government (n = 1). Results: We found that 32.3% of pharmacies (n = 10) had a medication disposal box and 12.9% (n = 4) had posted a flyer on medication disposal. Pharmacists perceived that patients benefit from disposal boxes and medication disposal is in their purview. Determinants of implementation included the cost of sustaining the intervention, polices of corporate and regional management, variable local control in the decision-making process to implement a disposal box, and experience with having a medication disposal box. Conclusion: Our findings highlight one way in which pharmacists can have a vital role in preventing diversion of opioid analgesics and associated consequences. There is a need to expand disposal boxes at pharmacies to increase community member accessibility and use. Future research is needed to determine the cost-effectiveness of expanding the scale of disposal box implementation in community pharmacies. (c) 2023 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.

The purpose of this qualitative study using focus groups was to explore the affective experiences of older adults enrolled in Bingocize (R), a health promotion program that combines bingo and exercise after program facilitators received a supplemental training developed by a recreational therapist titled, FUNctional Movement. The training emphasized participant enjoyment and autonomy support utilizing The Self-Determination Enjoyment comprised of 17 participants across three sessions, revealed that while the supplemental training may have improved engagement, many were unaware of the fall prevention components of Bingocize (R). Focus group themes included autonomy support, enjoyment, future desired activities, and barriers to physical activity. This may highlight a need to explicitly incorporate fall prevention and functional movement into Bingocize (R) training for facilitators. Additionally, integrating health education topics like sexual health and incontinence into Bingocize (R) could address participant needs and enhance program offerings. These findings may provide insights for refining Bingocize (R) training, aligning it more closely with participant expectations through a recreational therapy approach to physical activity in long-term care settings. The authors provide practice recommendations.

BackgroundPharmacy syringe sales are effective structural interventions to reduce bloodborne illnesses in populations, and are legal in all but two states. Yet evidence indicates reduced syringe sales in recent years. This study was designed as a feasibility test of an intervention to promote syringe sales by pharmacies in Arizona.MethodsA four-month pilot among three Arizona pharmacies measured feasibility and acceptability through monthly surveys to 18 enrolled pharmacy staff members.ResultsPharmacy staff reported increased ease of dispensing syringes across the study. Rankings of syringe dispensing as ‘easiest’ among 6 measured pharmacy practices increased from 38.9% at baseline to 50.1% post intervention module training, and to 83.3% at pilot conclusion. The majority (72.2%) of pharmacy staff agreed that intervention materials were easy to use. Over 70% indicated that the intervention was influential in their “being more open to selling syringes without a prescription to someone who might use them for illicit drug use,” and 61.1% reported that in the future, they were highly likely to dispense syringes to customers who would use them to inject drugs. A vast majority (92%) reported being likely to dispense subsidized naloxone if available to their pharmacy at no cost.ConclusionsAn education-based intervention was found to be feasible and acceptable to pharmacy staff and had an observed impact on perceptions of ease and likelihood of dispensing syringes without a prescription to people who may use them to inject drugs.

Background The U.S. overdose epidemic has continued to escalate with more than 100,000 deaths per year in the past several years, most of which involve opioids. Widespread availability of naloxone is part of a national solution to the crisis, and community pharmacies are well-poised to facilitate such distribution and provide additional harm reduction services. Objectives The primary objectives of this study were to (a) examine the usability of each of the separate intervention components prepared for PharmNet, (b) observe intervention fidelity through regularly scheduled site visits, and (c) explore the association between PharmNet implementation and the volume of naloxone sales and distribution in the pilot site. Practice description Here, we describe a carefully designed and tailored pharmacy harm reduction intervention called PharmNet that is designed to maximize harm reduction impact while minimizing utilization of pharmacist resources. It is a pragmatic awareness, service provision, and referral program that was developed through careful, iterative feasibility studies with pharmacists. Practice innovation PharmNet procedures include tools and steps to create awareness (e.g., yard signs and messaging for patients, reminder tools for pharmacists), facilitation of naloxone delivery from nonprofits, and provision of referral cards featuring local resources. Evaluation methods Evaluation included direct data collection and randomly scheduled fidelity site visits. Results The intervention was associated with an increase of 3.33 naloxone doses/mo being dispensed at cost (34.4% relative increase) and an overall increase of 9.33 naloxone doses/mo being dispensed via any mechanism (96.48% relative increase). Around 2.85 referral cards were issued to patients daily. Intervention fidelity was moderate, and the study provides valuable information for how to modify the study prior to a randomized trial. Conclusion With modifications informed by this pilot study, the PharmNet intervention merits a randomized trial to determine whether it causes increased naloxone dispensing in independent community pharmacies.

Background: Community pharmacists are at the frontline of patient care, yet their role in the opioid epidemic remains unclear. This qualitative study examines the perception of community pharmacists about their role in the opioid epidemic and challenges to fulfilling this role. Methods: A secondary analysis of cross-sectional survey data from an Indiana census of community managing pharmacists was conducted. Qualitative data were coded using a priori and emergent themes. A priori categories included the perceived role of pharmacists in the opioid epidemic and perception of practice barriers. Results: A total of 215 Indiana community managing pharmacists participated in this study. Pharmacists understood themselves as gatekeepers in preventing opioid misuse and overdose. Reported pharmacy practices included providing patient education and communicating with prescribers. Challenges to fulfilling this role included pharmacy structure and operation, lack of patient and provider clarity about pharmacist scope of practice, and pharmacist perception that that there is no available discretionary time to support additional services. Conclusion: Pharmacists believe they have a vital role in combatting opioid misuse and overdose but are hampered by structural aspects of pharmacy practice and lack of recognition of their role. Pharmacy associations and policy partners are encouraged to identify opportunities to address these barriers.

BACKGROUND:The overdose epidemic in the United States has continued to worsen despite substantial efforts to mitigate its harms. The opioid antagonist naloxone has been identified as a key means of reducing the prevalence of fatal overdoses. An important evidence-based approach to optimizing naloxone's impact is to seed it throughout the community, because bystanders are often able to reverse overdoses more quickly than first responders and sometimes are the only possible means of overdose reversal. As part of a multipronged approach to distributing naloxone nationwide, community pharmacies have been identified as ideal venues for naloxone dispensing, especially under standing orders. However, dispensing rates remain surprisingly low, and there is a need to understand how best to engage community pharmacies in naloxone-based harm reduction services.OBJECTIVE:The objective of this trial is to determine whether a tailored, pragmatic pharmacy intervention (PharmNet) results in greater naloxone dispensing relative to baseline (the prior 3 months) compared to a control condition. This pilot trial is intended to determine whether it is appropriate to invest the substantial resources that would be required to conduct a full-scale, randomized controlled study of PharmNet.METHODS:We will conduct a 3-month randomized controlled pilot trial consisting of 2 parallel groups with a 4:3 allocation ratio. A group of 7 independent pharmacies from rural areas in Indiana will be randomly assigned to either the PharmNet intervention arm (n=4) or the control arm (n=3). The primary outcome will be overall naloxone dispensing (both at cost and free), and secondary outcomes will include the distribution of referral cards and multiple variables at the level of individual staff members. Dispensing data will be collected for the 3 months prior to the intervention and the 3 months of the intervention, and all other data will be collected using a pretest-posttest design. The primary analysis will be a generalized linear mixed model with a Poisson distribution with fixed effects for group, time, and their interaction and a random effect for pharmacy ID to account for repeated measures within pharmacies.RESULTS:This study was approved by the Indiana University institutional review board in 2 phases (August 2, 2021, and April 26, 2022) and was funded by the Indiana University Grand Challenge: Responding to the Addictions Crisis.CONCLUSIONS:If this study produces evidence that the PharmNet intervention results in increased naloxone dispensing relative to control pharmacies, it will be both appropriate and important to study it in a large, full-scale randomized controlled trial.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/42373.

Equine-assisted therapy (EAT) is an increasingly popular intervention for people with various disabilities and diagnoses. However, a lack of evidence-based protocols has hampered efforts to provide standardization of treatment. The Galloping Towards Success (GTS) protocol was designed specifically for clients with moderate to severe autism spectrum disorder (ASD) and is described in this paper. The 15-week manualized EAT protocol was previously tested across multiple sites in Serbia and the U.S. (Dawson et al., 2022) demonstrating the protocol’s preliminary effectiveness in increasing social skills in 9 out of 10 individuals with moderate to severe ASD. This manuscript aims to provide professionals with information regarding the GTS 15-week protocol, including an introductory overview, description of participants, assessment, planning weekly intervention activities, evaluation procedures, documentation, limitations, and author comments. This protocol will help create consistency in facilitation among Certified Therapeutic Recreation Specialists (CTRS ) who use equine-assisted therapy to treat adolescents and young adults with moderate to severe ASD while equipping researchers with the means to conduct future evidence-based research in the area of equine-assisted therapies.

Background Pharmacists are positioned to play important roles in implementing evidence-based prevention and harm reduction approaches for opioid misuse and related health care outcomes such as human immunodeficiency virus (HIV) and hepatitis C. More research is needed to understand how best to facilitate harm reduction practices among pharmacists. Objectives This hypothesis-generating study investigated (1) whether subgroups (latent classes) were observable among pharmacists based on self-reported comfort with specific harm reduction behaviors, (2) whether having reported expertise in key content areas was associated with any latent classes that might be identified, and (3) whether comfort and training were associated with actually having dispensed syringes for likely nonprescription drug use. Methods This was a statewide census of community managing pharmacists in Arizona conducted from December 2018 to May 2019. Participants reported their degree of comfort with 10 harm reduction behaviors, their expertise (e.g., recent continuing pharmacy education or specialization) in selected content areas, and their syringe dispensing behavior. Additional sociodemographic information was also collected. Subgroups related to harm reduction were computed using latent class analysis, and associations between study variables were assessed using the Fisher's exact tests. Results Data suggested the existence of 4 latent, comfort-based harm reduction classes: high comfort, moderate comfort, and clinical comfort, and opioid prevention only. Reported expertise in pre-exposure prophylaxis for HIV was likely associated with harm reduction class. However, class membership was not associated with reporting having dispensed nonprescription syringes, although the single comfort item for syringe dispensing, by itself, was associated therewith. Conclusion Comfort with harm reduction likely clusters, so pharmacists may be broadly comfortable with topics or methods of harm reduction; however, comfort with a specific harm reduction pharmacy practice may be a better predictor of engaging in that behavior than harm reduction comfort class. In contrast, strategies to improve comfort, such as intervention development, might successfully be informed by pharmacists' latent class.

The field of recreational therapy has well-established methods of scientific collaboration within the United States yet historically there is a scarcity of International Research Collaborations (IRC). IRC could provide many benefits to the field as well as encourage the pollination of new ideas and philosophies to other continents and cultures. The purpose of this paper is to present an IRC framework and to describe the steps that would bring successful IRC to the field of recreational therapy.

Adolescent and young adults with a diagnosed autism spectrum disorder (ASD) in the severe to moderate functioning range were recruited for this study in Serbia and the United States (U.S.). A total of ten participants, five from each respective country, participated in a 15- week equine-assisted therapy (EAT) intervention that utilized ground-based learning through a manualized program approach. The purpose of the study was to test the effects of a manualized 15-week EAT intervention on the social functioning of individuals with severe to moderate ASD across two cultures using a single subject research design. Nine out of 10 participants displayed improved social functioning over the course of the 15- week EAT intervention in both cultures.

Background Overdose education and naloxone distribution (OEND) to laypersons are key approaches to reduce the incidence of opioid-involved overdoses. While some research has examined attitudes toward OEND, especially among pharmacists and first responders, our understanding of what laypersons believe about overdose and naloxone is surprisingly limited. Further, some scholars have expressed concerns about the prevalence of non-evidence-based beliefs about overdose and naloxone. We designed this study to analyze the prevalence, nature, and context of beliefs about naloxone and overdose among U.S. laypersons. Methods We conducted a cross-sectional study ( n = 702) using Prolific.co (representative of the U.S. population by age, gender, and race). Primary outcomes were the believability of six statements about overdose/naloxone on a seven-point Likert-type scale. Five statements were unsupported, and one was supported, by current scientific evidence. We used latent profile analysis to classify participants into belief groups, then used regression to study correlates of profile classification. Results Believability of the statements (7: extremely believable) ranged from m = 5.57 (SD = 1.38) for a scientifically supported idea (trained bystanders can reverse overdose with naloxone), to m = 3.33 (SD = 1.83) for a statement claiming opioid users can get high on naloxone. Participants were classified into three latent belief profiles: Profile 1 (most aligned with current evidence; n = 246), Profile 2 (moderately aligned; n = 351), and Profile 3 (least aligned, n = 105). Compared to Profile 1, several covariates were associated with categorization into Profiles 2 and 3, including lower trust in science (RRR = 0.36, 95%CI = 0.24–0.54; RRR = 0.21, 95%CI = 0.12–0.36, respectively), conservative political orientation (RRR = 1.41, 95%CI = 1.23–1.63; 3:RRR = 1.62, 95%CI = 1.35–1.95, respectively), and never being trained about naloxone (Profile 3: RRR = 3.37, 95%CI = 1.16–9.77). Conclusions Preliminary evidence suggests some U.S. laypersons simultaneously believe that bystander overdose prevention with naloxone can prevent overdose and one or more scientifically unsupported claims about naloxone/overdose. Categorization into clusters displaying such belief patterns was associated with low trust in science, conservative political orientation, and not having been trained about naloxone. Preregistration This cross-sectional study was preregistered prior to any data collection using the Open Science Framework: https://osf.io/c6ufv

Prospective longitudinal data collection is an important way for researchers and evaluators to assess change. In school-based settings, for low-risk and/or likely-beneficial interventions or surveys, data quality and ethical standards are both arguably stronger when using a waiver of parental consent-but doing so often requires the use of anonymous data collection methods. The standard solution to this problem has been the use of a self-generated identification code. However, such codes often incorporate personalized elements (e.g., birth month, middle initial) that, even when meeting the technical standard for anonymity, may raise concerns among both youth participants and their parents, potentially altering willingness to participate, response quality, or generating outrage. There may be value, therefore, in developing a self-generated identification code and matching approach that not only is technically anonymous but also appears anonymous to a research-naive individual. This article provides a proof of concept for a novel matching approach for school-based longitudinal data collection that potentially accomplishes this goal.

BACKGROUND:Schools increasingly prioritize social-emotional competence and bullying and cyberbullying prevention, so the development of novel, low-cost, and high-yield programs addressing these topics is important. Further, rigorous assessment of interventions prior to widespread dissemination is crucial.OBJECTIVE:This study assesses the effectiveness and implementation fidelity of the ACT Out! Social Issue Theater program, a 1-hour psychodramatic intervention by professional actors; it also measures students' receptiveness to the intervention.METHODS:This study is a 2-arm cluster randomized control trial with 1:1 allocation that randomized either to the ACT Out! intervention or control (treatment as usual) at the classroom level (n=76 classrooms in 12 schools across 5 counties in Indiana, comprised of 1571 students at pretest in fourth, seventh, and tenth grades). The primary outcomes were self-reported social-emotional competence, bullying perpetration, and bullying victimization; the secondary outcomes were receptiveness to the intervention, implementation fidelity (independent observer observation), and prespecified subanalyses of social-emotional competence for seventh- and tenth-grade students. All outcomes were collected at baseline and 2-week posttest, with planned 3-months posttest data collection prevented due to the COVID-19 pandemic.RESULTS:Intervention fidelity was uniformly excellent (>96% adherence), and students were highly receptive to the program. However, trial results did not support the hypothesis that the intervention would increase participants' social-emotional competence. The intervention's impact on bullying was complicated to interpret and included some evidence of small interaction effects (reduced cyberbullying victimization and increased physical bullying perpetration). Additionally, pooled within-group reductions were also observed and discussed but were not appropriate for causal attribution.CONCLUSIONS:This study found no superiority for a 1-hour ACT Out! intervention compared to treatment as usual for social-emotional competence or offline bullying, but some evidence of a small effect for cyberbullying. On the basis of these results and the within-group effects, as a next step, we encourage research into whether the ACT Out! intervention may engender a bystander effect not amenable to randomization by classroom. Therefore, we recommend a larger trial of the ACT Out! intervention that focuses specifically on cyberbullying, measures bystander behavior, is randomized by school, and is controlled for extant bullying prevention efforts at each school.TRIAL REGISTRATION:Clinicaltrials.gov NCT04097496; https://clinicaltrials.gov/ct2/show/NCT04097496.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/17900.

Funding for this study was provided by Lilly Endowment Inc, grant no. 2019 0543, to Claude McNeal Productions. Funding was provided to Prevention Insights via a subaward from that grant. Claude McNeal Productions and their representatives own the rights to the ACT Out! Social Issue Theater program. No one from that organization was involved in preparing the study protocol, interpreting findings, conducting analyses, or writing this manuscript, both as a matter of practice and per written agreement in the subaward to Prevention Insights.