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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

OBJECTIVE The objective of this article was to assess the impact on behavioral and socioemotional development, 2 to 6 years postintervention (depending on the curriculum), of Legacy for Children, a public health approach to improve child developmental outcomes among families living in poverty. METHODS Mothers who were recruited prenatally or at the time of childbirth participated in a set of Legacy parallel design randomized control trials between 2001 and 2009 in Miami, Florida, or Los Angeles, California. Of the initial 574 mother-child dyads, 364 completed at least 1 behavioral or socioemotional outcome measure at the third-grade follow-up. Intention-to-treat analyses compared Legacy and comparison groups on behavioral and socioemotional outcomes. RESULTS Children of Legacy mothers in Los Angeles were at lower risk for externalizing behaviors and poor adaptive skills than children whose mothers did not participate in the intervention. No significant outcome differences by group assignment were found in Miami. CONCLUSION Group-based positive parenting interventions such as Legacy may have a sustained impact on children's behavioral and socioemotional development several years after intervention completion.

This review examined evidence of the association between maternal pre-pregnancy overweight/obesity status and child neurodevelopmental outcomes. PubMed and PsycINFO databases were systematically searched for empirical studies published before April 2017 using keywords related to prenatal obesity and children's neurodevelopment. Of 1483 identified papers, 41 were included in the systematic review, and 32 articles representing 36 cohorts were included in the meta-analysis. Findings indicated that compared with children of normal weight mothers, children whose mothers were overweight or obese prior to pregnancy were at increased risk for compromised neurodevelopmental outcomes (overweight: OR = 1.17, 95% CI [1.11, 1.24], I2 = 65.51; obese: OR = 1.51; 95% CI [1.35, 1.69], I2 = 79.63). Pre-pregnancy obesity increased the risk of attention deficit-hyperactivity disorder (OR = 1.62; 95% CI [1.23, 2.14], I2 = 70.15), autism spectrum disorder (OR = 1.36; 95% CI [1.08, 1.70], I2 = 60.52), developmental delay (OR = 1.58; 95% CI [1.39, 1.79], I2 = 75.77) and emotional/behavioural problems (OR = 1.42; 95% CI [1.26, 1.59], I2 = 87.74). Given the current obesity prevalence among young adults and women of childbearing age, this association between maternal obesity during pregnancy and atypical child neurodevelopment represents a potentially high public health burden.

Background: Traditional methods for recruiting and maintaining contact with participants in cohort studies include print-based correspondence, which can be unidirectional, labor intensive, and slow. Leveraging technology can substantially enhance communication, maintain engagement of study participants in cohort studies, and facilitate data collection on a range of outcomes. Objective: This paper provides an overview of the development process and design of a cohort management platform (CMP) used in the Newborn Epigenetic STudy (NEST), a large longitudinal birth cohort study. Methods: The platform uses short message service (SMS) text messaging to facilitate interactive communication with participants; it also semiautomatically performs many recruitment and retention procedures typically completed by research assistants over the course of multiple study follow-up visits. Results: Since February 2016, 302 participants have consented to enrollment in the platform and 162 have enrolled with active engagement in the system. Daily reminders are being used to help improve adherence to the study’s accelerometer wear protocol. At the time of this report, 213 participants in our follow-up study who were also registered to use the CMP were eligible for the accelerometer protocol. Preliminary data show that texters (138/213, 64.8%), when compared to nontexters (75/213, 35.2%), had significantly longer average accelerometer-wearing hours (165.6 hours, SD 56.5, vs 145.3 hours, SD 58.5, P=.01) when instructed to wear the devices for 1 full week. Conclusions: This platform can serve as a model for enhancing communication and engagement with longitudinal study cohorts, especially those involved in studies assessing environmental exposures.