High impact of implementation on school-based smoking prevention: the X:IT study-a cluster-randomized smoking prevention trial.
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SUBMITTER: Bast LS
PROVIDER: S-EPMC5027074 | biostudies-other | 2016
REPOSITORIES: biostudies-other
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Project description:BackgroundDespite great need, the number of HIV prevention implementation studies remains limited. The challenge for researchers, in this time of limited HIV services agency resources, is to conceptualize and test how to disseminate efficacious, practical, and sustainable prevention programs more rapidly, and to understand how to do so in the absence of additional agency resources. We tested whether training and technical assistance (TA) in a couple-based HIV prevention program using a Web-based modality would yield greater program adoption of the program compared to training and TA in the same program in a manual-based modality among facilitators who delivered the interventions at 80 agencies in New York State.MethodsThis study used a cluster randomized controlled design. Participants were HIV services agencies (N = 80) and up to 6 staff members at each agency (N = 253). Agencies were recruited, matched on key variables, and randomly assigned to two conditions. Staff members participated in a four-day, face-to-face training session, followed by TA calls at two and four months, and follow-up assessments at 6, 12, and 18 months post- training and TA. The primary outcomes examined number of couples with whom staff implemented the program, mean number of sessions implemented, whether staff implemented at least one session or whether staff implemented a complete intervention (all six sessions) of the program. Outcomes were measured at both the agency and participant level.ResultsOver 18 months following training and TA, at least one participant from 13 (33%) Web-based assigned agencies and 19 (48%) traditional agencies reported program use. Longitudinal multilevel analysis found no differences between groups on any outcomes at the agency or participant level with one exception: Web-based agencies implemented the program with 35% fewer couples compared with staff at manual-based agencies (IRR 0.35, CI, 0.13-0.94).ConclusionGreater implementation of a Web-based program may require more resources and staff exposure, especially when paired with a couple-based modality. Manual-based and traditional programs may hold some advantage or ease for implementation, particularly at a time of low economic resources.Trial registrationClinicalTrials.gov identifier: NCT01863537.
| S-EPMC4172848 | biostudies-literature
Project description:ObjectivesWe conducted a cluster randomized controlled trial to test the a priori hypothesis that students attending an intervention middle school would be less likely to report physical adolescent relationship abuse (ARA) 1 year later compared with students attending a control school. Secondary objectives were to determine if the intervention reduced substance misuse, bullying, and fighting.MethodsTwenty-four Texas public middle schools were matched by the size of student enrollment, number of economically disadvantaged students, and race and ethnicity of the student body and randomly assigned to the intervention (n = 12; 1237 participants) or the control (n = 12; 1531participants) group. The intervention, Fourth R, is a classroom-based curriculum delivered by existing teachers and consists of 21 lessons on injury prevention, substance use, and growth and development.ResultsParticipants (50% female) self-reported ethnicity as Hispanic or Latinx (35%), Black or African American (24%), Asian American (17%), White (8%), and multiethnicity or other (16%). Among those who have dated, students in the intervention schools were less likely to report perpetrating physical ARA (intervention = 14.9% versus control = 18.3%) relative to students in the control schools (adjusted odds ratio, 0.66; 95% confidence interval, 0.43-1.00; P = .05). In the overall sample, no significant differences emerged between control and intervention groups with respect to substance misuse, fighting, and bullying.ConclusionsThe middle school version of Fourth R is effective in reducing physical ARA perpetration over at least 1 year. The intervention did not have an effect on bullying perpetration, physical fighting with peers, and substance misuse. Long-term assessment, especially follow-up that covers the transition to high school, is needed to examine the program benefit on key outcomes.
| S-EPMC9645690 | biostudies-literature
Project description:Encouraged by the Framework Convention on Tobacco Control, Korea has implemented a nationwide School-based Smoking Prevention Program (SSPP) to reduce the prevalence of youth smoking. This qualitative study explored the school contexts of launching the SSPP in Seoul, Korea. Five focus groups were studied with 29 lead teachers in charge of the SSPP. Thematic analysis reveals three key findings. First, while infrastructure was insufficiently prepared due to the abrupt implementation, lead teachers agreed on the purpose of the SSPP. However, they perceived the program as myopic in only targeting smoking students and spending the mandatory budgets as a burdensome task. Second, the SSPP increased experience-based activities, influenced smoking family members, and created a smoke-free school environment. Third, to ensure more effective implementation, school principals should support inducing staff engagement. The teachers also maintained that the SSPP must be institutionalized as part of regular curricula with standardized books. For a more meaningful impact, the SSPP needs instructors and counselors to support smoking cessation programs that reflect school contexts. The teachers urged tobacco prevention measures at community, policy, and society levels. This study provides insights into a nationwide approach to initiating school-based smoking prevention program to achieve a tobacco-free generation.
| S-EPMC8005052 | biostudies-literature
Project description:Background: Implementation strategies used to enhance the implementation of interventions during efficacy and effectiveness studies are rarely reported. Tracking and reporting implementation strategies during these phases has potential to improve future research studies and real-world implementation. We present an exemplar of how this might be executed by specifying and reporting the implementation strategies that were used during a school-based efficacy trial, Project POWER, which tested a trauma-informed prevention program delivered by a university research team, community members, and school staff facilitators in 29 schools. Methods: Following the conclusion of the 4-year trial, core Project POWER research team members identified the implementation strategies that supported intervention delivery during the trial using an established taxonomy of school-based implementation strategies. The actors, actions, action targets, temporality, dose, and implementation outcomes were specified using established implementation strategies reporting guidelines. Results: The research team identified 37 implementation strategies that were used during the Project POWER trial. Most strategies fell within the categories of Train and Educate Stakeholders, Use Evaluative and Iterative Strategies, and Develop Stakeholder Interrelationships. Actors included members of the research team and partner schools. Strategies were used multiple times during the preparation and implementation phases. Action targets were most often characteristics of individuals, implementation process, and characteristics of the inner setting. Strategies predominantly targeted the implementation outcomes of fidelity, acceptability, feasibility, and adoption. Conclusions: This study provided evidence that implementation strategies are used and can be identified in efficacy research using a retrospective approach. Identifying and specifying implementation strategies used during the initial phases of the translational research pipeline can inform the implementation strategies that are carried forward, adapted, or discontinued in future trials and routine practice to improve implementation and effectiveness outcomes. Plain Language Abstract Intervention development and testing often occurs separately from implementation planning. However, evaluating an intervention without considering how it will be subsequently used in real-world settings is a major factor contributing to the research-to-practice gap. During the rigorous testing of interventions, research teams invest significant effort and resources to ensure their program is delivered as intended and so that beneficial outcomes can be assessed. However, the methods or techniques used to support implementation (i.e., implementation strategies) are often not measured or specified to be used and evaluated during later research or included with intervention materials that are distributed to stakeholders; this is a missed opportunity. This study identifies and describes the implementation strategies used during a large school-based research trial of a universal trauma-informed prevention program delivered by a university research team, community members, and school staff. In collaboration with the trial’s research team, we identified 37 implementation strategies that were used during the trial and defined how each strategy was used, including: the actions (i.e., things done), people who carried out the strategies, the targets of the actions, when and how often during the implementation process the strategies were used, and which implementation outcome(s) the strategy was expected to impact. Explicating implementation strategies during early phases of intervention research in schools can inform which implementation supports to carry forward, adapt, or discontinue in future studies and routine practice.
| S-EPMC8577529 | biostudies-literature
Project description:ImportanceUnhealthy alcohol use is common and affects morbidity and mortality but is often neglected in medical settings, despite guidelines for both prevention and treatment.ObjectiveTo test an implementation intervention to increase (1) population-based alcohol-related prevention with brief interventions and (2) treatment of alcohol use disorder (AUD) in primary care implemented with a broader program of behavioral health integration.Design, setting, and participantsThe Sustained Patient-Centered Alcohol-Related Care (SPARC) trial was a stepped-wedge cluster randomized implementation trial, including 22 primary care practices in an integrated health system in Washington state. Participants consisted of all adult patients (aged ≥18 years) with primary care visits from January 2015 to July 2018. Data were analyzed from August 2018 to March 2021.InterventionsThe implementation intervention included 3 strategies: practice facilitation; electronic health record decision support; and performance feedback. Practices were randomly assigned launch dates, which placed them in 1 of 7 waves and defined the start of the practice's intervention period.Main outcomes and measuresCoprimary outcomes for prevention and AUD treatment were (1) the proportion of patients who had unhealthy alcohol use and brief intervention documented in the electronic health record (brief intervention) for prevention and (2) the proportion of patients who had newly diagnosed AUD and engaged in AUD treatment (AUD treatment engagement). Analyses compared monthly rates of primary and intermediate outcomes (eg, screening, diagnosis, treatment initiation) among all patients who visited primary care during usual care and intervention periods using mixed-effects regression.ResultsA total of 333 596 patients visited primary care (mean [SD] age, 48 [18] years; 193 583 [58%] female; 234 764 [70%] White individuals). The proportion with brief intervention was higher during SPARC intervention than usual care periods (57 vs 11 per 10 000 patients per month; P < .001). The proportion with AUD treatment engagement did not differ during intervention and usual care (1.4 vs 1.8 per 10 000 patients; P = .30). The intervention increased intermediate outcomes: screening (83.2% vs 20.8%; P < .001), new AUD diagnosis (33.8 vs 28.8 per 10 000; P = .003), and treatment initiation (7.8 vs 6.2 per 10 000; P = .04).Conclusions and relevanceIn this stepped-wedge cluster randomized implementation trial, the SPARC intervention resulted in modest increases in prevention (brief intervention) but not AUD treatment engagement in primary care, despite important increases in screening, new diagnoses, and treatment initiation.Trial registrationClinicalTrials.gov Identifier: NCT02675777.
| S-EPMC9972247 | biostudies-literature
Project description:ImportanceAdolescent relationship abuse (ARA) and sexual violence (SV) reported among adolescents point to the need for prevention among middle school-age youths.ObjectiveTo test an athletic coach-delivered relationship abuse and sexual violence prevention program among middle school male athletes.Design, setting, and participantsAn unblinded cluster randomized clinical trial from spring 2015 to fall 2017 at 41 middle schools (38 clusters). The study included 973 male middle school athletes (ages 11-14 years; grades 6-8; participation rate 50%) followed up for 1 year (retention 86%).InterventionsCoaching Boys Into Men (CBIM) is a prevention program that trains athletic coaches to talk to male athletes about (1) respectful relationship behaviors, (2) promoting more gender-equitable attitudes, and (3) positive bystander intervention when harmful behaviors among peers are witnessed.Main outcomes and measuresThe primary outcome was change in positive bystander behaviors (ie, intervening in peers' disrespectful or harmful behaviors); secondary outcomes were changes in recognition of what constitutes abusive behavior, intentions to intervene, gender-equitable attitudes, and reduction in recent ARA/SV perpetration (at end of sports season and 1-year follow up).ResultsOf the 973 participants, 530 were white (54.5%), 282 were black (29.0%), 14 were Hispanic (1.4%), and the remainder were multiracial, other race/ethnicity, or not reported. Positive bystander behaviors increased at end of sports season and at 1-year follow-up (relative risk, 1.51; 95% CI, 1.06-2.16 and 1.53; 95% CI, 1.10-2.12, respectively) as did recognition of abuse (mean risk difference, 0.14; 95% CI, 0.01-0.27 and 0.14; 95% CI, 0.00-0.28, respectively). At 1-year follow-up, among those who ever dated, athletes on teams receiving CBIM had lower odds of reporting recent ARA/SV perpetration (odds ratio, 0.24; 95% CI, 0.09-0.65). Gender attitudes and intentions to intervene did not differ between study arms. In exploratory intensity-adjusted and per protocol analyses, athletes on teams receiving CBIM were more likely to report positive bystander behaviors and to endorse equitable gender attitudes and less likely to report ARA and sexual harassment perpetration 1 year later.Conclusions and relevanceAn athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.Trial registrationClinicalTrials.gov Identifier: NCT02331238.
| S-EPMC6990799 | biostudies-literature
Project description:BackgroundThere is a need for more sustainable interventions and for assessing the effectiveness of school-based universal anti-bullying programmes in vulnerable populations. We assessed the efficacy of a multicomponent, web-enabled, school-based intervention that aims to improve school climate and reduce bullying (LINKlusive) relative to conventional practices (control condition).MethodsWe conducted a cluster randomised controlled trial in primary and secondary schools in Madrid, Spain. The primary outcome measure was peer-reported bullying victimisation after the 12-week intervention (study endpoint). We analysed data using longitudinal mixed-effects models. The trial was registered with the ISRCTN registry (15719015).FindingsWe included 20 schools (10 in each group); 6542 students participated at baseline; 6403 were assessed at study endpoint. After the intervention, there was a statistically significant reduction in bullying victimisation in both the intervention (OR 0.61, 95% CI [0.41, 0.90]) and control groups (OR 0.69, 95% CI [0.51, 0.92]), with no evidence of differences in the whole sample (OR 0.89, 95% CI [0.58, 1.36]; aOR 0.89, 95% CI [0.58, 1.37]). Subgroup analyses showed a statistically significant effect of LINKlusive on bullying victimisation in primary education (aOR 0.68, 95% CI [0.47, 0.98]). In students with peer-reported bullying victimisation at baseline, LINKlusive showed a statistically significant effect on depression (-1.43, 95% CI [-2.46, -0.40], adjusted standardised mean difference (SMD) -0.41) and quality of life (2.18, 95% CI [0.80, 3.56], adjusted SMD 0.45).InterpretationLINKlusive could be effective in reducing bullying victimisation in primary school students. Sustainable whole-school interventions to promote mental health and reduce risk factors are warranted to improve outcomes in young people, especially in the early years of education.FundingInstituto de Salud Carlos III, Spanish Ministry of Science and Innovation.
| S-EPMC10839589 | biostudies-literature
Project description:ImportanceSchool-based interventions offer an opportunity for health promotion in adolescence.ObjectiveTo assess the effect of 2 multicomponent educational health promotion strategies of differing duration and intensity on adolescents' cardiovascular health (CVH).Design, setting, and participantsThe SI! Program for Secondary Schools is a 4-year cluster randomized clinical intervention trial conducted in 24 secondary schools from Barcelona and Madrid, Spain, from September 7, 2017, to July 31, 2021. Eligible participants were adolescents enrolled in the first grade of secondary school.InterventionsSchools and their participants were randomized to receive a health promotion intervention (SI! Program) over 4 school years (long-term intervention [LTI], 8 schools, 412 adolescents) or 2 school years (short-term intervention [STI], 8 schools, 504 adolescents) or to receive the standard curriculum (control, 8 schools, 441 adolescents).Main outcome and measuresThe primary end point was the between-group difference at 2 and 4 years in the change from baseline of the overall CVH score, as defined by the American Heart Association (range, 0-14 points, with a higher score indicating a healthier CVH profile). Intervention effects were tested with multilevel mixed-effects models. A complete-case intention-to-treat analysis was performed as the primary analysis.ResultsOf the randomized students, the study enrolled 1326 adolescents (684 [51.6%] boys, mean [SD] age, 12.5 [0.4] years at recruitment) with a study completion rate of 86.0%. Baseline overall CVH scores were 10.3 points in the LTI group, 10.6 points in the STI group, and 10.5 points in the control group. After 2 years, at halfway through the LTI and at the end of the STI, the difference in the CVH score change was 0.44 points (95% CI, 0.01-0.87; P = .04) between the LTI group and the control group and 0.18 points (95% CI, -0.25 to 0.61; P = .39) between the STI group and the control group. At 4 years, differences for the LTI and STI groups vs control were 0.12 points (LTI: 95% CI, -0.19 to 0.43; P = .42) and 0.13 points (STI: 95% CI, -0.17 to 0.44; P = .38). No adverse events were reported.Conclusions and relevanceOverall, the tested school-based health promotion strategies in this randomized clinical trial had a neutral effect on the CVH of the adolescents. Although there was evidence of a marginal beneficial effect at a point halfway through implementation in the LTI group, such a benefit was not noted at 4 years. Further research is warranted into the efficacy of school-based health promotion programs.Trial registrationClinicalTrials.gov Identifier: NCT03504059.
| S-EPMC10398546 | biostudies-literature
Project description:To determine the effectiveness of a school-based curriculum, Eliminating the Stigma of Differences (ESD), in improving attitudinal and/or behavioral contexts regarding mental illness in schools and increasing the likelihood that youth seek treatment for mental health problems when needed. We conducted a cluster randomized trial in sixth-grade classes from 14 schools in 2011 and 2012 with follow-up at 6-month intervals through 24 months (2012-2015). Using a fully crossed 2 × 2 × 2 factorial design, we compared ESD to a no-intervention control and to 2 comparator interventions: (1) contact with 2 young adults with a history of mental illness and (2) exposure to antistigma printed materials. We implemented interventions in classrooms in an ethnically and socioeconomically diverse school district. There were 416 youth who participated in the follow-up, and 312 (75%) of these participated for the full 2 years. Outcome measures were knowledge and positive attitudes, social distance from peers with mental illness, and mental health treatment seeking. Youth assigned to ESD reported greater knowledge and positive attitudes and reduced social distance (Cohen's d = 0.35 and 0.16, respectively) than youth in the comparator interventions and no-intervention groups across the 2-year follow-up. Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention. ESD shows potential for improving the social climate related to mental illnesses in schools and increasing treatment seeking when needed. ESD and interventions like it show promise as part of a public mental health response to youth with mental health needs in schools.
| S-EPMC7263048 | biostudies-literature
Project description:BackgroundThe StayBalanced programme has shown positive effects on fall prevention, balance control and fear of falling. Despite convincing evidence on the efficacy and effectiveness of balance training, there is a gap between research findings and what is provided in community-based and clinical health care settings. Therefore, transferring evidence-based balance training into clinical practice is needed.MethodsThis project, designed as a hybrid type 3 trial, is a cluster-randomized study with a mixed-method design, carried out in primary health care settings. The aim is to investigate the effectiveness of two different strategies to facilitate the implementation of an intervention, the StayBalanced balance training programme, in primary health care, including evaluation of relative changes and maintenance in patient outcomes between intervention arms over 24 months. The StayBalanced programme will be launched through a website with information on the balance training and how to use it in clinical practice. One implementation strategy will include close facilitation, i.e. support and close follow-ups initiated by the researchers, in addition to access to the website. The other strategy simply includes access to the StayBalanced website. Outcome measures in the project consist of implementation outcomes, such as acceptability, feasibility, fidelity and sustainability of the StayBalanced programme. Outcomes at an individual level for older adults participating in the training will include fall-related concerns, health-related quality of life, balance performance, gait, physical activity, muscle strength in lower extremities, number of falls and compliance with training.DiscussionThis study will generate new understanding of effective strategies for transferring research to clinical practice and thereby reduce an important knowledge gap, as well as aid decision-making for future implementation of evidence-based methods. Furthermore, it will contribute to improved balance and gait, increased level of physical activity and function, and improved health-related quality of life for the individuals participating in the programme.Trial registrationClinicalTrials.gov NCT02909374 . Registered on September 21, 2016.
| S-EPMC7913398 | biostudies-literature