High impact of implementation on school-based smoking prevention: the X:IT study-a cluster-randomized smoking prevention trial.
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ABSTRACT:
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: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:ObjectivesTo 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.MethodsWe 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.ResultsYouth 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.ConclusionsESD 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: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: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
Project description:BackgroundMental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial.MethodsThe trial was carried out with teachers in South Australian high schools. Teachers at 7 schools received training and those at another 7 were wait-listed for future training. The effects of the training on teachers were evaluated using questionnaires pre- and post-training and at 6 months follow-up. The questionnaires assessed mental health knowledge, stigmatizing attitudes, confidence in providing help to others, help actually provided, school policy and procedures, and teacher mental health. The indirect effects on students were evaluated using questionnaires at pre-training and at follow-up which assessed any mental health help and information received from school staff, and also the mental health of the student.ResultsThe training increased teachers' knowledge, changed beliefs about treatment to be more like those of mental health professionals, reduced some aspects of stigma, and increased confidence in providing help to students and colleagues. There was an indirect effect on students, who reported receiving more mental health information from school staff. Most of the changes found were sustained 6 months after training. However, no effects were found on teachers' individual support towards students with mental health problems or on student mental health.ConclusionsMental Health First Aid training has positive effects on teachers' mental health knowledge, attitudes, confidence and some aspects of their behaviour.Trial registrationACTRN12608000561381.
| S-EPMC2908569 | biostudies-literature
Project description:BackgroundMany school-based physical activity (PA) interventions are complex and have modest effects when delivered in real world contexts. A commonly reported barrier to students' PA, particularly among girls, are uniforms that are impractical (e.g. tunic/dress and black leather shoes). Modifying student uniforms may represent a simple intervention to enhance student PA. The primary aim of this trial was to assess the impact of a PA enabling uniform intervention (shorts, polo shirt and sports shoes) on girls' moderate-to-vigorous physical activity (MVPA) and total PA i.e. counts per minute (cpm).MethodsA cluster randomized controlled trial was undertaken in 42 primary schools in New South Wales, Australia. Schools were randomized on one school day to the intervention group, where students wore a PA enabling uniform (their sports uniform) or a control group, where students wore their usual traditional uniform. Student PA was measured using wrist-worn Actigraph GT3X and GT9X accelerometers. Linear mixed models controlling for student characteristics were used to examine the effects of the intervention..ResultsOf the 3351 eligible students, 2315 (69.1%) had parental consent and 2180 of these consenting students participated (94.2%) of which 1847 (84.7%) were included in the analysis. For the primary aim the study found no significant differences between girls at schools allocated to the intervention relative to the control on change in MVPA (0.76?min, 95% CI -?0.47 to 1.99, p?=?0.22) or cpm (36.99, 95% CI -?13.88 to 87.86, p?=?0.15). Exploratory analysis revealed small effects for a number of findings, including significant reduction in sedentary activity (-?1.77, 95% CI -?3.40 to -?0.14, p?=?0.035) among all students at schools allocated to the intervention, and non-significant improvements in girls' light intensity PA (1.47?min, 95% CI -?0.06 to 3.00, p?=?0.059) and sedentary activity (-?2.23?min; 95% CI -?4.49 to 0.02, p?=?0.052).ConclusionThe findings suggests that the intervention may yield small improvements in some measure of PA and require substantiation in a larger RCT with longer-term follow-up. The inclusion of additional intervention components may be required to achieve more meaningful effects.Trial registrationThe trial was prospectively registered with Australian New Zealand Clinical Trials Register ACTRN12617001266358 1st September 2017.
| S-EPMC7825216 | biostudies-literature