scholarly journals Study Protocol For A Cluster Randomized Trial of A School, Family and Community Intervention For Preventing Drug Misuse Among Older Adolescents in the Cherokee Nation

2021 ◽  
Author(s):  
Kelli A Komro ◽  
Terrence K. Kominsky ◽  
Juli R. Skinner ◽  
Melvin D Livingston ◽  
Bethany J. Livingston ◽  
...  
Keyword(s):  
High School ◽  
American Indian ◽  
Randomized Trial ◽  
Community Intervention ◽  
Cluster Randomized Trial ◽  
Drug Misuse ◽  
Cherokee Nation ◽  
Intervention Protocol ◽  
Secondary Outcomes ◽  
Cluster Randomized

Abstract Background: The national opioid crisis has disproportionately burdened rural White populations and American Indian/Alaska Native (AI/AN) populations. Therefore, Cherokee Nation and Emory University public health scientists have designed an opioid prevention trial to be conducted in rural communities in the Cherokee Nation (northeast Oklahoma) with AI and other (mostly White) adolescents and young adults. Our goal is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. Two distinct intervention approaches—community organizing as implemented in our established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral, as implemented in our established CONNECT intervention protocol—will be integrated with skill-based training for adults to strengthen social support for youth and strategic media. Further, we will test systems for sustained implementation within existing organizational structures of the Cherokee Nation and local schools and communities. This study protocol describes the cluster randomized trial, designed to measure implementation and evaluate effectiveness on primary and secondary outcomes.Methods: Using a cluster randomized controlled design and constrained randomization, this trial will allocate 20 high schools and surrounding communities to either an intervention or delayed-intervention comparison condition. With a proposed sample of 20 high schools, all enrolled 10th grade students in fall 2021 will be eligible for participation. During the trial, we will: (1) implement interventions through the Cherokee Nation, and measure implementation processes and fidelity; (2) measure opioid and other drug use and secondary outcomes every six months among a cohort of high school students followed over three years through their transition out of high school; (3) test via a cluster randomized trial the effect of the integrated CMCA-CONNECT intervention; and (4) analyze implementation costs. Discussion: This trial will expand upon previous research advancing the scientific evidence regarding prevention of opioid and other drug misuse during the critical developmental period of late adolescent transition to young adulthood among a sample of American Indian and other youth living within the Cherokee Nation reservation.Trial registration: ClinicalTrials.gov, NCT04839978. Registered April 9, 2021, https://clinicaltrials.gov/ct2/show/NCT04839978

Protocol for a cluster randomized trial of a school, family and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation

2021 ◽  
Author(s):  
Kelli A. Komro ◽  
Terrence K. Kominsky ◽  
Juli R. Skinner ◽  
Melvin D. Livingston ◽  
Bethany J. Livingston ◽  
...  
Keyword(s):  
High School ◽  
High Schools ◽  
American Indian ◽  
Randomized Trial ◽  
Community Intervention ◽  
Cluster Randomized Trial ◽  
Drug Misuse ◽  
Cherokee Nation ◽  
Intervention Protocol ◽  
Cluster Randomized

Abstract Background: The national opioid crisis has disproportionately burdened rural White populations and American Indian/Alaska Native (AI/AN) populations. Therefore, Cherokee Nation and Emory University public health scientists have designed an opioid prevention trial to be conducted in rural communities in the Cherokee Nation (northeast Oklahoma) with AI and other (mostly White) adolescents and young adults. Our goal is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. Two distinct intervention approaches—community organizing as implemented in our established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral, as implemented in our established CONNECT intervention protocol—will be expanded, integrated, and supported with skill-based training to strengthen social support and strategic media to further enhance effects in preventing and reducing drug misuse. This new trial will build on our previous trials, improving design and implementation of the interventions with increased focus on opioids and other drugs. Further, we will test systems for sustained implementation within existing organizational structures of the Cherokee Nation and local schools and communities. This study protocol describes the cluster randomized trial, designed to measure implementation and evaluate effectiveness on primary and secondary outcomes.Methods: Using a cluster randomized controlled design and constrained randomization, this trial will allocate 20 high schools and surrounding communities to either an intervention or delayed-intervention comparison condition. With a proposed sample of 20 high schools, all enrolled 10th grade students in fall 2021 will be eligible for participation. During the trial, we will: (1) implement interventions through the Cherokee Nation, and measure implementation processes and fidelity; (2) measure opioid and other drug use and secondary outcomes every six months among a cohort of high school students followed over three years through their transition out of high school; (3) test via a cluster randomized trial the effect of the integrated CMCA-CONNECT intervention; and (4) analyze implementation costs. Discussion: This trial will expand upon previous research advancing the scientific evidence regarding prevention of opioid and other drug misuse during the critical developmental period of late adolescent transition to young adulthood among a sample of American Indian and other youth living within the Cherokee Nation reservation.Trial registration: ClinicalTrials.gov, NCT04839978. Registered April 9, 2021, https://clinicaltrials.gov/ct2/show/NCT04839978

Reducing mental-illness stigma via high school clubs: A matched-pair, cluster-randomized trial.

2020 ◽  
Vol 5 (2) ◽  
pp. 230-239
Author(s):  
Shaikh I. Ahmad ◽  
Bennett L. Leventhal ◽  
Brittany N. Nielsen ◽  
Stephen P. Hinshaw
Keyword(s):  
High School ◽  
Mental Illness ◽  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Mental Illness Stigma ◽  
Matched Pair ◽  
Cluster Randomized

scholarly journals 515. Acquisition of Antibiotic-Resistant Gram-Negative Bacteria in the Benefits of Universal Glove and Gown (BUGG) Cluster Randomized Trial

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S248-S249
Author(s):  
Anthony Harris ◽  
Daniel Morgan ◽  
Lisa Harris ◽  
Laurence S Magder ◽  
Lyndsay M O’Hara ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Effect Sizes ◽  
Gram Negative Bacteria ◽  
Patient Contact ◽  
Antibiotic Resistant ◽  
Gram Negative ◽  
Carbapenem Resistant ◽  
Secondary Outcomes ◽  
Cluster Randomized

Abstract Background The Benefits of Universal Gloves and Gowns (BUGG) randomized trial found a decrease in MRSA acquisition, no effect on VRE acquisition and no increase in adverse events with the intervention of wearing gloves and gowns for all patient contact in the intensive care unit (ICU). The objective of the study was to assess whether wearing gloves and gowns for all patient contact in the ICU decreases the acquisition of antibiotic-resistant Gram-negative bacteria. Methods Design: Secondary study of the BUGG cluster-randomized trial. Participants: 20 medical and surgical ICUs in 20 US hospitals. Intervention: Healthcare workers were required to wear gloves and gowns when entering any patient room compared with standard care. Main outcomes and measures: The primary composite outcome was acquisition of any antibiotic-resistant Gram-negative bacteria based on surveillance cultures collected on admission and discharge. Secondary outcomes were acquisition of carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacteriaceae, or ESBL-producing Enterobacteriaceae. Results For the primary outcome, the intervention had a RR of 0.90 (95% CI 0.71 to 1.12, P = 0.34). Effects on the secondary outcomes were: carbapenem-resistant Enterobacteriaceae [RR 0.86 (95% CI, 0.60 to 1.24), P = 0.43], carbapenem-resistant Acinetobacter [RR 0.81 (95% CI, 0.52 to 1.27) P = 0.36], carbapenem-resistant Pseudomonas [RR 0.88 (95% CI, 0.55 to 1.42) P = 0.62], ESBL producing bacteria [RR 0.94, (95% CI, 0.71 to 1.24) P = 0.67]. Conclusion The association of universal glove and gown use in the ICU with acquisition of antibiotic-resistant Gram-negative bacteria was inconclusive. The observed rate ratios for all five outcomes suggest that the intervention was protective, however, none were statistically significant. The study was likely underpowered to detect statistical significance for the effect sizes found. Individual hospitals should consider implementing the intervention based on the importance of these organisms at their hospital, effect sizes, confidence intervals, and cost. Disclosures All authors: No reported disclosures.

scholarly journals Mental health first aid training for high school teachers: a cluster randomized trial

2010 ◽  
Vol 10 (1) ◽  
Author(s):  
Anthony F Jorm ◽  
Betty A Kitchener ◽  
Michael G Sawyer ◽  
Helen Scales ◽  
Stefan Cvetkovski
Keyword(s):  
Mental Health ◽  
High School ◽  
Randomized Trial ◽  
High School Teachers ◽  
Cluster Randomized Trial ◽  
First Aid ◽  
Mental Health First Aid ◽  
School Teachers ◽  
First Aid Training ◽  
Cluster Randomized

scholarly journals Intermittent preventive treatment of malaria delivered to primary schoolchildren provided effective individual protection in Jinja, Uganda: secondary outcomes of a cluster-randomized trial (START-IPT)

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Andrea M. Rehman ◽  
Catherine Maiteki-Sebuguzi ◽  
Samuel Gonahasa ◽  
Jaffer Okiring ◽  
Simon P. Kigozi ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Intermittent Preventive Treatment ◽  
Preventive Treatment ◽  
Cluster Randomized Trial ◽  
Adjusted Risk ◽  
School Based ◽  
Primary Schoolchildren ◽  
Secondary Outcomes ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Intermittent preventive treatment (IPT) of malaria is recommended as policy for certain high-risk populations, but not currently for schoolchildren. A cluster-randomized trial was conducted to evaluate the effect of IPT with dihydroartemisinin–piperaquine (DP) on primary schoolchildren in Jinja, Uganda. Results of the impact of IPT of schoolchildren on community-level transmission have been reported previously. Here, secondary outcomes from a school-based survey are presented. Methods Eighty-four clusters (one primary school plus 100 households) were randomized to intervention and control (1:1 ratio). Participants from intervention schools received monthly IPT with DP for up to 6 rounds (June–December 2014). At endline (November–December 2014), randomly selected children from all 84 schools were surveyed (13 per school) and thick blood smears were done. Those with fever or history of fever were tested with rapid diagnostic tests (RDTs) for malaria. Haemoglobin was measured in every fifth participant. Outcome measures included prevalence of asexual parasites and gametocytes (by microscopy), and prevalence of anaemia. Prevalence outcomes were analysed using generalized linear Poisson models with log link function, incorporating a cluster-level random intercept and quantified using prevalence risk ratios. Results Among 23,280 students listed on the 42 intervention school registers, 10,079 (43.3%) aged 5–20 years were enrolled into the IPT intervention and received at least one dose of DP; of these, 9286 (92.1%) received at least one full (3-day) course. In total, 1092 children were enrolled into the final school survey (546 per arm) and had a thick blood smear done; of these, 255 had haemoglobin measured (129 intervention, 126 control). Children in the intervention arm were less likely to have asexual parasites (9.2% intervention vs 44.1% control, adjusted risk ratio [aRR] 0.22 [95% CI 0.16–0.30] p < 0.001), gametocytes (3.1% intervention vs 9.5% control, aRR 0.34 [95% CI 0.20–0.56] p < 0.001), fever (20.2% intervention vs 56.2% control, aRR 0.35 [95% CI 0.25–0.50] p < 0.001), or symptomatic malaria (5.1% intervention vs 35.7% control, aRR 0.14 [95% CI 0.08–0.26] p < 0.001). Prevalence of anaemia and mean haemoglobin were similar in both study arms. Conclusions School-aged children are a major reservoir of malaria parasites. Delivering IPT to schoolchildren would benefit individual children and may reduce transmission. School-based IPT could help to intensify malaria control toward elimination, and should be considered for policies and programmes. Trial registration Clinicaltrials.gov (NCT02009215), Registered 11 December 2013. https://clinicaltrials.gov/ct2/show/NCT02009215

Adolescent Stress Treatment Study: A Cluster Randomized Trial

2018 ◽  
Vol 28 (7) ◽  
pp. 795-811 ◽  
Author(s):  
Stephanie Lynch ◽  
Conni DeBlieck ◽  
Linda C. Summers ◽  
Anita Reinhardt ◽  
Wanda Borges
Keyword(s):  
High School ◽  
High School Students ◽  
Randomized Trial ◽  
Stress Reduction ◽  
Short Form ◽  
Cluster Randomized Trial ◽  
School Students ◽  
Stress Treatment ◽  
Adolescent Stress ◽  
Cluster Randomized

High school students experience a variety of stressors. Mental health issues are critical to their health. The “Adolescent Stress Treatment (AST) Study: A Cluster Randomized Trial” compared the efficacy of two stress reduction devices, the EnergyPod™ and the SleepWing™. The EnergyPod™ is a device that provides a semiprivate acoustical and visual environment for rest, stress reduction, and sleep. The SleepWing™ is a smaller device offering similar benefits. High school students were offered the opportunity to participate in the AST study when they exhibited signs of agitation. The students completed the Profile of Mood States–Short Form (POMS-SF) pre- and postintervention. Total Mood Disturbance (TMD) was measured from the POMS-SF and significant improvement postintervention ( p < .001), regardless of intervention used. POMS-SF subscales were all significantly improved no matter which device was used. All participants in the study dramatically improved their mood after being in either therapeutic device.

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