Correlates of bullying behaviors among a sample of North American Indigenous adolescents

The purpose of this study was to examine the relationship between familial, educational, and psychosocial factors and bullying among 702 North American Indigenous adolescents aged 11–14 years. The study used multinomial logistic regression models to differentiate correlates of bully perpetration and victimization versus being neither and between being a perpetrator versus being a victim. Analyses reveal that being a bully victim had different correlates than being a perpetrator. Perceived discrimination was associated with increased odds of being either a victim or a perpetrator, relative to being neither. Several factors differentiated being a bully perpetrator from being a bully victim: adolescent age, parental warmth and support, depressive symptoms, anger, and school adjustment. These findings expand upon the limited understanding of the factors associated with bullying among North American Indigenous youth. Bullying intervention and prevention programs that target Indigenous adolescents should be culturally grounded and begin early within the family.     

Assessment of QTc-prolonging potential of BX471 in healthy volunteers. A 'thorough QTc study' following ICH E14 using various QT correction methods

AIMS

Within the framework of the clinical development of BX471, this study was intended to provide experience in conducting ‘thorough QT_c studies’ according to ICH E14. A broad range of QT correction methods and analysis strategies was employed.

METHODS

A double-blind, placebo- and positive-controlled, single-centre, three-way cross-over study was conducted in 74 healthy volunteers. Electrocardiograms were read by blinded experts. QT correction methods included Bazett''s (QT_cB), Fridericia''s (QT_cF) and several regression-based corrections.

RESULTS

There was a significant QT_cF prolongation of 10.26 ms by the positive control compared with placebo [95% confidence interval (7.83, 12.70)]. BX471 at therapeutic doses did not cause substantial QT_c prolongation [QT_cF estimate 2.93 ms, 95% confidence interval (1.00, 4.86); QT_cB estimate 3.30 ms, 95% confidence interval (0.85, 5.74)]. Regression-based QT correction methods yielded similar results to Fridericia''s correction [e.g. using a linear regression across the study population, QT_c estimate 2.39 ms, 95% confidence interval (0.55, 4.23)]. Differences between the various regression-based correction methods were small. Results were not affected by whether the QT corrections were performed per ECG or per beat.

CONCLUSIONS

BX471 does not cause meaningful QT_c prolongation. Three QT correction methods may be sufficient in future studies: Bazett''s (required by regulatory authorities), Fridericia''s (as the most reliable fixed formula) and a regression-based correction (individually or population-based), each performed per ECG (i.e. applied to the means of several beats of one ECG recording).