Information fraction estimation: Strategies for a phase 3 non-inferiority maximum duration design with time to event outcome

There is considerable debate surrounding the choice of methods to estimate information fraction for futility monitoring in a randomized non-inferiority maximum duration trial. This question was motivated by a pediatric oncology study that aimed to establish non-inferiority for two primary outcomes. While non-inferiority was determined for one outcome, the futility monitoring of the other outcome failed to stop the trial early, despite accumulating evidence of inferiority. For a one-sided trial design for which the intervention is inferior to the standard therapy, futility monitoring should provide the opportunity to terminate the trial early. Our research focuses on the Total Control Only (TCO) method, which is defined as a ratio of observed events to total events exclusively within the standard treatment regimen. We investigate its properties in stopping a trial early in favor of inferiority. Simulation results comparing the TCO method with alternative methods, one based on the assumption of an inferior treatment effect (TH0), and the other based on a specified hypothesis of a non-inferior treatment effect (THA), were provided under various pediatric oncology trial design settings. The TCO method is the only method that provides unbiased information fraction estimates regardless of the hypothesis assumptions and exhibits a good power and a comparable type I error rate at each interim analysis compared to other methods. Although none of the methods is uniformly superior on all criteria, the TCO method possesses favorable characteristics, making it a compelling choice for estimating the information fraction when the aim is to reduce cancer treatment-related adverse outcomes.     

Longitudinal neural and behavioral trajectories of charity contributions across adolescence

This study examined the development of prosocial charity donations and neural activity in the ventral striatum when gaining rewards for self and for charity. Participants 10–22 years (95% European heritage) participated in three annual behavioral-fMRI waves (T1: n = 160, T2: n = 167, T3: n = 175). Behaviorally, donations to charity as measured with an economic Dictator Game increased with age. Perspective taking also increased with age. In contrast, self-gain and charity-gain enjoyment decreased with age. Ventral striatum activity was higher for rewards for self than for charity, but this difference decreased during adolescence. Latent growth curve models revealed that higher donations were associated with a smaller difference between ventral striatum activation for self and charity. These findings show longitudinal brain–donations associations in adolescence.     

Predicting the development of dependency on the teacher in late childhood: The role of peer victimization and peer beliefs

Evidence indicates that being overly dependent on the teacher places children's academic and socioemotional development at risk. However, little is known about what predicts dependency on the teacher or how the quality of interactions occurring within the classroom peer system may impact how children relate to their teacher the following school year. The current study tested the proposition that peer victimization may result in negative perceptions of classmates (i.e., peer beliefs), leading to overreliance on teachers. Data were collected from 365 children in the fall and spring of their third/fourth grade year and the fall of their fourth/fifth grade year (195 girls; M_age = 8.92 years; 86.8% white). Peer-reports of peer victimization and self-reports of peer beliefs were collected at each wave of the study. Teacher-reports of dependency were collected in the fall of the first and second years of the study. Path analyses showed that for boys peer victimization directly predicted higher levels of dependency on the next year's teacher, and, for boys and girls, peer victimization indirectly predicted dependency through lower levels of prosocial peer beliefs. Supplemental analyses assessing teacher-child conflict and closeness confirmed that findings were unique to dependency. These results underscore how children's perceptions of their classmates may contribute to dependency in their relationships with teachers and highlight the need for further research into the transactional and cumulative impact of difficulties within peer and teacher relationships.     

Child and Youth Coaching in families experiencing complex and multiple problems: A longitudinal evaluation study

Studies investigating services for families experiencing complex and multiple problems have emphasized the need for more child-centred support. The aim of this longitudinal study was to investigate whether providing child-centred services (Child and Youth Coaching) combined with family-focused services (Ten for the Future) is effective for children growing up in families experiencing complex and multiple problems. Children's psychosocial skills, emotional and behavioural problems, and the quality of their pedagogical environment were measured at baseline, 6 months and 12 months. Parent and coach reports of children indicated for Child and Youth Coaching (n = 57) and nonindicated children (n = 18) were analysed using repeated measures multilevel models. Both parents and coaches reported improved psychosocial skills of children, but changes were only significant for coach reports. In both reports, no significant decrease in emotional and behavioural problems was observed for both indicated and nonindicated children. Many children still experienced considerable problems at case closure. Furthermore, no significant improvement in quality of the pedagogical environment was observed in both groups. Given the limitations in this study, more research is needed to identify whether these findings can be replicated and attributed to the Child and Youth Coaching and Ten for the Future programmes.