The Randomized Controlled Trial as a Demonstration Project: An Ethical Perspective

American Journal of Psychiatry (Impact Factor: 12.3). 08/2009; 166(7):743-5. DOI: 10.1176/appi.ajp.2009.09040538
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    • "One further limitation in the BEIP study is the significant amount of placement changes that occurred after randomization, particularly in the care as usual group. The study of institutionalized children, such as those in the BEIP, raises ethical issues (Miller, 2009; Millum & Emanuel, 2007; Zeanah, Fox, & Nelson, 2012; Zeanah et al., 2006). Given the extensive findings across studies of PI children that exposure to institutional care has severe negative impacts on child development, additional randomized control trials are unlikely. "
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    ABSTRACT: Building upon the transactional model of brain development, we explore the impact of early maternal deprivation on neural development and plasticity in three neural systems: hyperactivity/impulsivity, executive function, and hypothalamic–pituitary–adrenal axis functioning across rodent, nonhuman primate, and human studies. Recognizing the complexity of early maternal–infant interactions, we limit our cross-species comparisons to data from rodent models of artificial rearing, nonhuman primate studies of peer rearing, and the relations between these two experimental approaches and human studies of children exposed to the early severe psychosocial deprivation associated with institutional care. In addition to discussing the strengths and limitations of these paradigms, we present the current state of research on the neurobiological impact of early maternal deprivation and the evidence of sensitive periods, noting methodological challenges. Integrating data across preclinical animal models and human studies, we speculate about the underlying biological mechanisms; the differential impact of deprivation due to temporal factors including onset, offset, and duration of the exposure; and the possibility and consequences of reopening of sensitive periods during adolescence.
    Development and Psychopathology 05/2015; 27(02):347-367. DOI:10.1017/S0954579415000036 · 4.89 Impact Factor
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    • "The study was approved by Institutional Review Boards at Boston Children's Hospital, Harvard Medical School, Tulane University, University of Maryland, and the local commissions on child protection in each sector of Bucharest. Ethical issues have been discussed by the present authors (Zeanah, Fox, & Nelson, 2012; Zeanah et al., 2006), and others (Miller, 2009; Millum & Emanuel, 2007). "
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    ABSTRACT: An individual’s neurodevelopmental and cognitive sequelae to negative early experiences may, in part, be explained by genetic susceptibility. We examined whether extreme differences in the early caregiving environment, defined as exposure to severe psychosocial deprivation associated with institutional care compared to normative rearing, interacted with a biologically informed genoset comprising BDNF (rs6265), COMT (rs4680), and SIRT1 (rs3758391) to predict distinct outcomes of neurodevelopment at age 8 (N = 193, 97 males and 96 females). Ethnicity was categorized as Romanian (71%), Roma (21%), unknown (7%), or other (1%). We identified a significant interaction between early caregiving environment (i.e., institutionalized versus never institutionalized children) and the a priori defined genoset for full-scale IQ, two spatial working memory tasks, and prefrontal cortex gray matter volume. Model validation was performed using a bootstrap resampling procedure. Although we hypothesized that the effect of this genoset would operate in a manner consistent with differential susceptibility, our results demonstrate a complex interaction where vantage susceptibility, diathesis stress, and differential susceptibility are implicated.
    International Journal of Behavioral Development 06/2014; 39(2). DOI:10.1177/0165025414538557 · 1.58 Impact Factor
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    • "The study was approved by the local Commissions for Child Protection as well as the Institutional Review Boards of the three U.S. universities of the principal investigators. Ethical issues have been discussed previously in some detail by us (Zeanah, Fox, & Nelson, 2012; Zeanah et al., 2006) and by others (Miller, 2009; Millum & Emanuel, 2007). "
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    ABSTRACT: Institutional rearing of young children has been demonstrated to increase risk for a broad range of psychiatric disorders and other impairments. This has led many countries to consider or to invest in foster care. However, no study to date has explored potential differences in psychiatric symptoms in children placed in different types of foster care. We assessed internalizing disorders, externalizing disorders, and attention deficit hyperactivity disorder (ADHD) in 54-month-old children living with foster families. We compared one group of children living in high-quality foster families who had benefited from specialized training and support to another group of children placed with government-sponsored foster care in Bucharest, Romania. After controlling for duration of time spent in foster care, there was a main group effect in predicting ADHD (p = .021) and a marginal group × gender interaction effect. No effects were noted for signs of externalizing disorders. There was, however, a significant group × gender interaction effect of signs of internalizing disorders (p = .007), with the girls in high-quality foster care having less severe symptomatology than did their counterparts in the government-sponsored group. Governments must invest in quality interventions for their most vulnerable citizens to prevent serious and potentially lasting problems. © 2014 Michigan Association for Infant Mental Health.
    Infant Mental Health Journal 03/2014; DOI:10.1002/imhj.21428 · 0.61 Impact Factor
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