Statistical considerations for design and analysis of stability,comparability and formulation tests

This article considers designed experiments for stability, comparability, and formulation testing that are analyzed with regression models in which the degradation rate is a fixed effect. In this setting, we investigate how the number of lots, the number of time points and their locations affect the precision of the entities of interest, leverages of the time points, detection of non-linearity and interim analyses. This investigation shows that modifying time point locations suggested by ICH for stability studies can significantly improve these objectives. In addition, we show that estimates of precision can be biased when a regression model that assumes independent measurements is used in the presence of within-assay session correlation. This bias can lead to longer shelf life estimates in stability studies and loss of power in comparability studies. Mixed-effect models that take into account within-assay session correlation are shown to reduce this bias. The findings in this article are obtained from well known statistical theory but provide valuable practical advice to scientists and statisticians designing and interpreting these types of experiments.     

The Varied Impact of Couple Relationship Breakdown on Children: Implications for Practice and Policy

This review of international literature assesses the impacts that the relationship breakdown of parents has on children and factors that can provide support should this occur. The parental separation process causes significant albeit short‐term distress for most children, with a minority reporting longer‐term outcomes such as socio‐economic disadvantage, behavioural problems, poor educational achievement, and physical and emotional health problems. Factors increasing the likelihood of sustained disadvantage include: poverty; poor parent–child relationships; continuing parental conflict, multiple transitions in family formation; and poor maternal mental health. Supporting the factors that can improve child outcomes, exploring opportune ways to strengthen couple and family relationships, and integrating the views of children (for example, in court‐based dispute resolution) are the leading implications for practice and policy.     

Physiological Regulation at 9 Months of Age in Infants Prenatally Exposed to Cigarettes

The primary purpose of this study was to examine the association between prenatal cigarette exposure and physiological regulation at 9 months of age. Specifically, we explored the possibility that any association between prenatal cigarette exposure and infant physiological regulation was moderated by postnatal environmental tobacco smoke (ETS) exposure or infant gender. We evaluated whether male infants with prenatal cigarette exposure or infants who were also exposed to ETS after birth had the highest levels of physiological dysregulation. Respiratory sinus arrhythmia (RSA) was obtained from 206 (142 exposed and 64 nonexposed) infants during a baseline period and during procedures designed to elicit both positive and negative affect. There was a significant suppression of RSA during the negative affect task for nonexposed infants, but not for exposed infants. Postnatal ETS exposure did not moderate this association; however, gender did moderate this association such that boys with prenatal cigarette exposure had a significant increase in RSA rather than the suppression seen among both nonexposed boys and girls. These results provide additional support for the idea that boys are particularly vulnerable to the effects of prenatal cigarette exposure.     

Children's Development as Participation in Everyday Practices across Different Institutions

Children participate in different institutional collectives in their everyday life. Home, school, and kindergarten are the institutional contexts that most children share. Although there are variations between home practices and school practices, they collectively share a common core framed by societal conditions. In drawing upon Vygotsky's (1998) Vygotsky, L. S. 1998. The collected works of L. S. Vygotsky (M. J. Hall, Trans., Vol. 5, Child Psychology), New York: Kluwer Academic/Plenum.  [Google Scholar] theory of the social situation of development and Hedegaard's (2009) Hedegaard, M. 2009. “Children's development from a cultural-historical approach: Children's activity in everyday local settings as foundation for their development”. In Mind, Culture, and Activity Vol. 16, 64–82. [Taylor & Francis Online] , [Google Scholar] theory of development conceptualised as the child's participation within and across several institutions at the same time, it has been possible to examine how school practices influence home practice and the child's social situation of development. A case study of an Australian child's participation across different institutions (family and school) was undertaken to capture and analyse the dynamic processes through which development was afforded. In the case study there was a large disjunction between institutional practices of the home and school that the child had to negotiate. Due to teacher knowledge of only the child's relation to the school institution, and not the home institution, the affordances for development and the child's changing relations to his environment, were invisible to the educators in this study. The findings suggest foregrounding an understanding of children's development as changes in children's activities and thereby changing their relations to reality across institutional practices in order to support a broader view of development in early childhood education.     

A Cultural-Historical Study of How Children from Hong Kong Immigrant Families Develop a Learning Motive within Everyday Family Practices in Australia

This article draws on a cultural-historical theorization of child development alongside the Chinese concept of learning in order to study children's development in the Hong Kong Australian community. In particular, it aims to understand in detail how a 9-year-old child develops a learning motive under highly structured family practices. The data analysed were selected from a larger set of data involving 80 hr of video observations generated from the recording of everyday practices in three Hong Kong immigrant families. The findings indicate that encouragement plays an important role in bridging the gap between parental demands and the child's wishes, which assists the child to appropriate family values, thus facilitating the development of a learning motive and learning itself.     

Re-signing: A Cultural-Historical Study of Signs for Supporting Young Children’s Development of Emotion Regulation

Recent cultural-historical literature stresses the need for understanding the role of signs in emotional development. This article examined how the signification of children’s emotions in everyday parent–child interactions creates the conditions for the emergence of intrapersonal emotion regulation. Four families with children ages 3–6 years were studied in Australia. Findings indicated that parents’ re-signing supported the emergence of children’s intrapersonal emotion regulation. We argue that the cultural line of emotional development needs to be foregrounded and the process of development theorized, thus contributing to better understandings of the process, rather than the product of children’s development of emotion regulation.     

A support group for individuals recently testing HIV positive: A psycho‐educational group model

The present paper describes an eight‐week psycho‐educational group model that is easily adaptable to any agency that is concerned with a comprehensive package of services for counseling HIV + persons, as well as for others involved in the long‐term management of issues related to the health threat presented by HIV infection.     

Slavery: A Supplementary Teaching Bibliography

This study will argue that from 1916 to 1935 Emperor Haile Selassie I adopted a two-pronged strategy of supporting the gradual abolition of slavery while taking steps towards its immediate abolition. Emperor Haile Selassie I was compelled to adopt a policy of gradual abolition due to the deposition of Iyasu V, the institutional nature of Ethiopian slavery and the agricultural primacy of the Ethiopian economy. This article will also contend that Emperor Haile Selassie I sought the immediate abolition of slavery because he wanted to improve the international image of Ethiopia, stave off a European invasion and/or partition, and prevent Ethiopia from becoming a mandate of the League of Nations.