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- Cortese, S., et al.
(author)
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The future of child and adolescent clinical psychopharmacology: A systematic review of phase 2, 3, or 4 randomized controlled trials of pharmacologic agents without regulatory approval or for unapproved indications
- 2023
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In: Neuroscience and Biobehavioral Reviews. - : Elsevier BV. - 0149-7634. ; 149
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Journal article (peer-reviewed)abstract
- We aimed to identify promising novel medications for child and adolescent mental health problems. We systematically searched https://clinicaltrials.gov/ and https://www.clinicaltrialsregister.eu/ (from 01/01/ 2010-08/23/2022) for phase 2 or 3 randomized controlled trials (RCTs) of medications without regulatory approval in the US, Europe or Asia, including also RCTs of dietary interventions/probiotics. Additionally, we searched phase 4 RCTs of agents targeting unlicensed indications for children/adolescents with mental health disorders. We retrieved 234 ongoing or completed RCTs, including 26 (11%) with positive findings on & GE; 1 primary outcome, 43 (18%) with negative/unavailable results on every primary outcome, and 165 (70%) without publicly available statistical results. The only two compounds with evidence of significant effects that
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- Sisask, M, et al.
(author)
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Teacher satisfaction with school and psychological well-being affects their readiness to help children with mental health problems
- 2014
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In: HEALTH EDUCATION JOURNAL. - : SAGE Publications. - 0017-8969 .- 1748-8176. ; 73:4, s. 382-393
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Journal article (other academic/artistic)abstract
- In support of a whole-school approach to mental health promotion, this study was conducted to find out whether and how significantly teachers’ satisfaction with school and their subjective psychological well-being are related to the belief that they can help pupils with mental health problems. Design: Cross-sectional data were collected as a part of the European Union’s, Seventh Framework Programme for Research (FP7) Saving and Empowering Young Lives in Europe (SEYLE) study. One of the elements of the SEYLE study was to evaluate teachers’ attitudes and knowledge related to pupils’ mental health issues and their own psychological well-being, as well as their satisfaction with the school environment. Setting: The sample of schools from the SEYLE study sites representing 11 European countries was randomly chosen according to prior defined inclusion and exclusion criteria. The final cross-sectional database used for analysis in the current study comprised 2485 teachers from 158 randomly selected schools. Method: Respondents’ belief that teachers can help pupils with mental health problems served as the outcome variable in our predictions with probability of the positive answer being modelled in the logistic regression analysis. Teachers’ subjective psychological well-being and school satisfaction were included as independent variables in the logistic regression model and several other relevant variables were added to statistically control for them. Multiple models were tested in order to obtain the final model. Results: Logistic regression models showed that better satisfaction with general school climate, higher psychological well-being, and the ability to understand pupils’ mental health problems increased the odds of teachers’ readiness to help pupils with mental health problems. Conclusion: By providing a good school environment, by valuing the subjective psychological well-being of the teachers, and by providing adequate training to fulfil their ‘gatekeeper’ role, the preconditions to improve the mental health of the pupils they teach will be achieved. These suggestions are in line with a whole-school approach to mental health promotion.
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- Villa, Luisa L., et al.
(author)
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Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
- 2007
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In: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 356:19, s. 1915-1927
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Journal article (peer-reviewed)abstract
- BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group.
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