Evidence in promoting positive parenting through the Program-Guide to Develop Emotional Competences

This study aims at providing evidence of the effectiveness of the Program-Guide to Develop Emotional Competences in promoting positive parenting. Contextual, institutional, methodological and professional issues were taken into account to develop a social innovation experience to support parenting as a preventive measure to family conflicts. The study describes both the contents of the Program-Guide and the methodological and evaluation issues that trained professionals need to consider when delivering the Program-Guide to families in natural contexts. Information was gathered and analyzed from 259 parents with children of ages 1-18 who participated in 26 parent training groups. A pre- and post-test design showed that after finishing the sessions parents perceived themselves more competent as parents according to the five dimensions of parenting competences considered: (1) emotional self-regulation abilities; (2) self-esteem and assertiveness; (3) communication strategies; (4) strategies to solve conflicts and to negotiate; and (5) strategies to establish coherent norms, limits and consequences to promote positive discipline. The study presents a discussion on these results from evidence-based parenting programs, as well as some strengths and limitations of the study, together with some suggestions for further research.

Clinical trial designs of new medicinal products for treating schizophrenia: discussion of EMA's Guideline and a Better Long Term Trial Design

Background and Objectives: Schizophrenia is a severe chronic disease. Endpoint variables lack objectivity and the diagnostic criteria have evolved with time. In order to guide the development of new drugs, European Medicines Agency (EMA) issued a guideline on the clinical investigation of medicinal products for the treatment of schizophrenia. Methods: Authors reviewed and discussed the efficacy trial part of the Guideline. Results: The Guideline divides clinical efficacy trials into short-term trials and long-term trials. The short-term three-arm trial is recommended to replace the short-term two-arm active-controlled non-inferiority trial because the latter has sensitivity issues. The Guideline ultimately makes that three-arm trial a superiority trial. The Guideline discusses four types of long-term trial designs. The randomized withdrawal trial design has some disadvantages. Long-term two-arm active-controlled non-inferiority trial is not recommended due to the sensitivity issue. Extension of the short-term trial is only suitable for extension of the short-term two-arm active-controlled superiority trial. The Guideline suggests that a hybrid design of a randomized withdrawal trial incorporated into a long-term parallel trial might be optimal. However, such a design has some disadvantages and might be too complex to be carried out. Authors suggest instead a three-group long-term trial design, which could provide comparison between test drug and active comparator along with comparison between the test drug and placebo. This alternative could arguably be much easier to carry out compared with the hybrid design. Conclusions: The three-group long-term design merits further discussion and evaluation.