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Effectiveness of a universal classroom-based preventive intervention (PAX GBG): A research protocol for a matched-pair cluster-randomized controlled trial.

ABSTRACT: Introduction:The PAX Good Behavior Game (PAX GBG) is a universal classroom-based program that promotes children's mental health. In Estonia, the intervention is delivered to first grade students (aged seven to eight) within the regular school curriculum. The current work describes a protocol for a cluster-randomized controlled trial (RCT) of the PAX GBG conducted in Estonia. Design and methods:This is an ongoing, pragmatic, two-year, matched-pair, cluster-RCT conducted in Estonian elementary schools. Schools were matched to pairs based on their geographical location and number of students per classroom. One school in each pair was randomly selected to receive the intervention and the other placed on a wait-list as a control. 42 schools provided baseline data during the autumn of 2016. Data is collected at two more points in time - seven months and 19 months post-baseline. Outcomes of children's mental health and behavior are measured by the teacher- and parent-rated Strengths and Difficulties Questionnaire, parent-rated Swanson, Nolan, and Pelham - IV Questionnaire and the Go/No-Go task completed by children. Teachers also rate their self-efficacy and overall classroom behavior. Discussion:This study aims to test the effectiveness of the intervention in Estonian classrooms with a newer version of the rigorously tested GBG program. To our knowledge, this study is the first to measure the effects of the intervention on children's inhibitory control, which has been associated with externalizing problems in the literature. The results from this trial will provide further understanding into how the program influences children's well-being and self-control. Trial registration:ClinicalTrials.gov registry (NCT02865603).

SUBMITTER: Streimann K

PROVIDER: S-EPMC5898545 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Effectiveness of a universal classroom-based preventive intervention (PAX GBG): A research protocol for a matched-pair cluster-randomized controlled trial.

Streimann Karin K Trummal Aire A Klandorf Kai K Akkermann Kirsti K Sisask Merike M Toros Karmen K Selart Anne A

Contemporary clinical trials communications 20170830

<h4>Introduction</h4>The PAX Good Behavior Game (PAX GBG) is a universal classroom-based program that promotes children's mental health. In Estonia, the intervention is delivered to first grade students (aged seven to eight) within the regular school curriculum. The current work describes a protocol for a cluster-randomized controlled trial (RCT) of the PAX GBG conducted in Estonia.<h4>Design and methods</h4>This is an ongoing, pragmatic, two-year, matched-pair, cluster-RCT conducted in Estonian ...[more]

PMID: 29696198

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Project description:BACKGROUND:Interventions directed at after school programs (ASPs) have the potential to support physical activity (PA) in young children. Research has indicated that interventions that emphasize competence building among the ASP staff can lead to increased PA among the children. The present study evaluates the effectiveness of the Active Play in ASP intervention-a program for ASP staff aimed at supporting physical activity among first graders in ASP. METHODS:We used a matched-pair cluster randomized design and included 456 first graders from 14 schools in Norway. From these, 7 ASPs received the intervention (N = 229), while 7 acted as controls (N = 227). Measurements were taken at baseline, immediately post intervention (7 month follow-up) and after a year (19 month follow-up). The primary outcome was moderate to vigorous physical activity (MVPA), which was estimated with predefined cut points of counts per minute (CPM) and expressed as minutes/hour. Secondary outcomes were vigorous and light intensity physical activity (VPA and LPA) and sedentary behavior. The analyses of intervention effects were based on between-group differences in outcome changes between the 3 measurement points and were conducted using a mixed-effects model for repeated measures using categorical time. In exploratory analyses, we investigated gender, baseline body mass index, and baseline CPM as potential effect modifiers. RESULTS:No significant intervention effects was observed on MVPA (0.55 min/hour [99% CI -0.55:1.64]) or on the secondary outcomes, min/hour of LPA, VPA or sedentary behavior. Exploratory analyses indicated that among the 50% least physically active children at baseline, children in intervention ASPs reduced sedentary time from baseline to 19 months follow up by 1.67 min/hour (95% CI -3.12:-0.21) compared to the controls. CONCLUSIONS:Although the intervention did not significantly increase the mean MVPA among the children in the intervention ASPs compared to controls, it did seem to have a small effect by reducing sedentary behavior time among the least active children. An even stronger emphasis on how to identify less active children and support their activity may be needed in order to increase their PA and further reduce sedentary behavior time. TRIAL REGISTRATION:ClinicalTrials; NCT02954614, Registered 3 November 2016, -Retrospectively registered, first participant enrolled August 2016.

Project description:Patients at risk for generating high health care expenditures often receive fragmented, low-quality, inefficient health care. Guided Care is designed to provide proactive, coordinated, comprehensive care for such patients.We hypothesized that Guided Care, compared to usual care, produces better functional health and quality of care, while reducing the use of expensive health services.32-month, single-blind, matched-pair, cluster-randomized controlled trial of Guided Care, conducted in eight community-based primary care practices.The "Hierarchical Condition Category" (HCC) predictive model was used to identify high-risk older patients who were insured by fee-for-service Medicare, a Medicare Advantage plan or Tricare. Patients with HCC scores in the highest quartile (at risk for generating high health care expenditures during the coming year) were eligible to participate.A registered nurse collaborated with two to five primary care physicians in providing eight services to participants: comprehensive assessment, evidence-based care planning, proactive monitoring, care coordination, transitional care, coaching for self-management, caregiver support, and access to community-based services.Functional health was measured using the Short Form-36. Quality of care and health services utilization were measured using the Patient Assessment of Chronic Illness Care and health insurance claims, respectively.Of the eligible patients, 904 (37.8 %) gave written consent to participate; of these, 477 (52.8 %) completed the final interview, and 848 (93.8 %) provided complete claims data. In intention-to-treat analyses, Guided Care did not significantly improve participants' functional health, but it was associated with significantly higher participant ratings of the quality of care (difference?=?0.27, 95 % CI?=?0.08-0.45) and 29 % lower use of home care (95 % CI?=?3-48 %).Guided Care improves high-risk older patients' ratings of the quality of their care, and it reduces their use of home care, but it does not appear to improve their functional health.

Project description:BackgroundMaternal and perinatal mortality continue to be a high priority problem on the health agendas of less developed countries. Despite the progress made in the last decade to quantify the magnitude of maternal mortality, few interventions have been implemented with the intent to measure impact directly on maternal or perinatal deaths. The success of interventions implemented in less developed countries to reduce mortality has been questioned, in terms of the tendency to maintain a clinical perspective with a focus on purely medical care separate from community-based approaches that take cultural and social aspects of maternal and perinatal deaths into account. Our innovative approach utilizes both the clinical and community perspectives; moreover, our study will report the weight that each of these components may have had on reducing perinatal mortality and increasing institution-based deliveries.Methods/designA matched pair cluster-randomized trial will be conducted in clinics in four rural indigenous districts with the highest maternal mortality ratios in Guatemala. The individual clinic will serve as the unit of randomization, with 15 matched pairs of control and intervention clinics composing the final sample. Three interventions will be implemented in indigenous, rural and poor populations: a simulation training program for emergency obstetric and perinatal care, increased participation of the professional midwife in strengthening the link between traditional birth attendants (TBA) and the formal health care system, and a social marketing campaign to promote institution-based deliveries. No external intervention is planned for control clinics, although enhanced monitoring, surveillance and data collection will occur throughout the study in all clinics throughout the four districts. All obstetric events occurring in any of the participating health facilities and districts during the 18 months implementation period will be included in the analysis, controlling for the cluster design. Our main outcome measures will be the change in perinatal mortality and in the proportion of institution-based deliveries.DiscussionA unique feature of this protocol is that we are not proposing an individual intervention, but rather a package of interventions, which is designed to address the complexities and realities of maternal and perinatal mortality in developing countries. To date, many other countries, has focused its efforts to decrease maternal mortality indirectly by improving infrastructure and data collection systems rather than on implementing specific interventions to directly improve outcomes.Trial registrationClinicalTrial.gov,http://NCT01653626.

Project description:ObjectivesInterventions addressing the individual and environmental protective factors of adolescents are suggested to have potential for reducing adolescent substance use. While universally delivered school-based substance use prevention interventions are common, previous studies have suggested variable effectiveness by subgroups of students. An exploratory study was undertaken to examine the differential effectiveness of a universal school-based resilience intervention on adolescent substance use and protective factors according to their sociodemographic and previous substance use.DesignSecondary analysis of data from a cluster-randomised controlled trial.Setting32 Australian secondary schools.ParticipantsCohort of grade 7 students (n=3155) followed up in grade 10 (aged 15-16 years; 2014; n=2105).InterventionThree-year universal school-based intervention implemented by school staff that targeted a range of student resilience protective factors (2012-2014).MeasurementsPrimary outcomes included: tobacco (recent, number of cigarettes) and alcohol (recent, 'risk' and number of drinks) use, and secondary outcomes included: marijuana (recent) and other illicit substance (recent) use, and aggregate individual and environmental protective factor scores. Generalised and linear mixed models examined interactions between treatment and student subgroups (gender; socioeconomic disadvantage (low/high); geographic location (major city/inner regional/outer regional-remote); and previous substance use (non-user/user)) at follow-up (36 models).ResultsAnalysis of student follow-up data showed no differential intervention effect for any substance use or protective factor outcome for any subgroup, with the exception of one differential effect found by socioeconomic status for the outcome of mean number of cigarettes smoked by recent smokers (p=0.003). There was no evidence of an intervention effect within the low (mean difference (MD) -12.89, 95%?CI -26.00 to 0.23) or high (MD 16.36, 95%?CI -1.03 to 33.76) socioeconomic subgroups.ConclusionsNo evidence of an intervention effect on substance use and protective factors was found according to student subgroups defined by sociodemographic characteristics or previous substance use.Trial registration numberACTRN12611000606987.

Project description:BackgroundInternational debate around the best models of speech and language therapy provision for children with language disorders has highlighted the need for research into classroom-based approaches and intervention dosage. Working memory (WM) is a cognitive skill linked to attention and language. 'Recall to Enhance Children's Attention, Language and Learning' (RECALL) is a novel, 6-week, classroom-based intervention delivered by health professionals (HPs) and teachers. It is designed to target WM and enhance attention and language skills in 4-5 year olds.MethodsA cluster randomised feasibility trial was conducted to investigate aspects of the feasibility of a definitive trial to evaluate RECALL: (i) recruitment and sampling procedures; (ii) compliance and fidelity; (iii) the acceptability of RECALL to HPs and teachers; (iv) the appropriateness of the outcome measures. Six classes of 4-5 year olds participated: two received RECALL, two received an existing intervention targeting attention skills (not underpinned by WM theory), and two received education as usual (no intervention). Ten children in each class (n = 60) were sampled to assess the appropriateness of the outcome measures. Classroom observations were conducted to measure fidelity and semi-structured interviews with HPs, and teachers explored the acceptability of RECALL.ResultsThe recruitment targets were met, and all six schools completed the trial, but the sampling procedures require modification. Compliance was good (95% of RECALL sessions were delivered), but fidelity to the intervention protocol varied between 76% and 45% across the two schools. This was influenced by large class sizes, child factors, and facilitator factors, e.g., their understanding of the theory underpinning the intervention. The lack of fidelity reduced the dose (number of practice items) accessed by individual children, particularly those most at risk. There were mixed findings regarding the acceptability of RECALL and the appropriateness of the outcome measures.ConclusionsThe trial protocol could be easily scaled-up in a future definitive trial, with an amended sampling procedure. RECALL should be repackaged as a small group intervention to enhance the fidelity of its delivery and its acceptability to HPs and teachers. This study highlights the need for thorough training for professionals who deliver classroom-based interventions for children with language disorders.Trial registrationISRCTN13633886 . Registered on 7 September 2018.

Project description:OBJECTIVES:This study aimed to assess the cost-effectiveness of the Steps Towards Alcohol Misuse Prevention Programme (STAMPP) compared with education as normal (EAN) in reducing self-reported heavy episodic drinking (HED) in adolescents. DESIGN:This is a cost-effectiveness analysis from a public sector perspective conducted as part of a cluster randomised trial. SETTING:This study was conducted in 105 high schools in Northern Ireland and in Scotland. PARTICIPANTS:Students in school year 8/S1 (aged 11-12) at baseline were included in the study. INTERVENTIONS:This is a classroom-based alcohol education curricula, combined with a brief alcohol intervention for parents/carers. OUTCOME MEASURES:The outcome of this study is the cost per young person experiencing HED avoided due to STAMPP at 33 months from baseline. RESULTS:The total cost of STAMPP was £85?900, equivalent to £818 per school and £15 per pupil. Due to very low uptake of the parental component, we calculated costs of £692 per school and £13 per pupil without this element. Costs per pupil were reduced further to £426 per school and £8 per pupil when it was assumed there were no additional costs of classroom delivery if STAMPP was delivered as part of activities such as personal, social, health and economic education. STAMPP was associated with a significantly greater proportion of pupils experiencing a heavy drinking episode avoided (0.08/8%) and slightly lower public sector costs (mean difference -£17.19). At a notional willingness-to-pay threshold of £15 (reflecting the cost of STAMPP), the probability of STAMPP being cost-effective was 56%. This level of uncertainty reflected the substantial variability in the cost differences between groups. CONCLUSIONS:STAMPP was relatively low cost and reduced HED. STAMPP was not associated with any clear public sector cost savings, but neither did it increase them or lead to any cost-shifting within the public sector categories. Further research is required to establish if the cost-effectiveness of STAMPP is sustained in the long term. TRIAL REGISTRATION NUMBER:ISRCTN47028486; Results.

Dataset Information

Effectiveness of a universal classroom-based preventive intervention (PAX GBG): A research protocol for a matched-pair cluster-randomized controlled trial.

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Effectiveness of a universal classroom-based preventive intervention (PAX GBG): A research protocol for a matched-pair cluster-randomized controlled trial.

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