Conducting Research with At-Risk and High-Risk Children and Adolescents

Author(s):  
M. Katherine Hutchinson ◽  
Elizabeth Burgess Dowdell
BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024974 ◽  
Author(s):  
Clémentine Cabridain ◽  
Hélène Aubert ◽  
Bertrand Kaeffer ◽  
Virginie Badon ◽  
Marion Boivin ◽  
...  

IntroductionAtopic dermatitis (AD) is a chronic inflammatory disease affecting 10%–15% of children in Europe. There is a need for new primary preventive therapeutic strategies in at-risk populations. Recent research has indicated that atopic diseases are associated with a disrupted gut microbial ‘balance’ in early life raising the possibility that interventions which yield optimal patterns of microflora could improve host’s health. Prebiotics, sugars with immunomodulatory properties that stimulate the diversity of the digestive microbiota, are ideal candidates for such research. So far, most clinical trials have focused on improving infant gut colonisation postnatally. However, prenatal life is a crucial period during which different tolerance mechanisms are put in place. We aim to determine whether antenatal prebiotics supplementation prevents AD in high-risk children.Methods and analysisThis is a randomised, multicentre, double-blind, trial to evaluate the effectiveness of antenatal prebiotic maternal supplementation (galacto-oligosaccharide/inulin) in pregnant women versus placebo on the occurrence of AD at 1 year of age in at-risk children (defined as having a maternal history of atopic disease). Participating women will be randomised to daily ingestion of a prebiotics or placebo (maltodextrin) from 20 weeks’ gestation until delivery. The primary outcome is the prevalence of AD at 1 year of age, using the version of the UK Working Party Diagnostic Criteria optimised for preventive studies. Key secondary endpoints are AD severity, quality of life and prebiotics tolerance. The target sample size is 376 women (188 patients per group) which will provide 80% power to detect a 33% reduction of the risk of AD in the verum group (α=0.05). The primary analysis will be based on the intention-to-treat principle.Ethics and disseminationResults will be presented in peer-reviewed journals and at international conferences. Ethics approval for the study was obtained from the institutional ethical review board of ‘Comité de Protection des Personnes Sud Ouest—Outre-Mer III’ of the University Hospital Centre of Bordeaux (2017/13).Trial registration numberNCT03183440; Pre-results.


PEDIATRICS ◽  
1990 ◽  
Vol 86 (3) ◽  
pp. 398-404
Author(s):  
James A. Blackman ◽  
Julie Bretthauer

The validity of the Pediatric Evaluation of Educational Readiness (PEER) in evaluating high-risk 5-year-old children who passed developmental screenings through age 30 months was assessed by comparing it with a battery of standardized psychoeducational tests. High-risk children who "failed" the PEER scored significantly below those who "passed" the PEER on tests of verbal, perceptual-motor, and preacademic skills. Furthermore, scores on the PEER of the high-risk group were significantly below those of a normal comparison group. When the standardized test battery was used as the true indicator of developmental concerns, the sensitivity of the PEER averaged 0.60; specificity averaged 0.88. The overall hit rate was 78%. False-positive rate was 27%, the false-negative rate, 20%. Observations of behavior, including attention and activity, correlated at the .63 level (P < .001) with those made independently by a psychometrist. The correlation of these observations to ratings of behavior by parents on the Child Behavior Checklist was .32 (P < .001). It is concluded that the PEER distinguishes between groups of children at risk and not at risk for learning problems; however, in individual cases, the PEER and the standardized test agreed that a child had problems only 60% of the time. Thus two out of five children who may have problems would be missed by the PEER. The observations of behavior feature of the PEER seemed to be a reliable measure and to have some relationship to concerns indicated by parents. With the health history and physical examination, the PEER can assist in the developmental surveillance of children known to be at risk for learning problems. However, based on this study, it cannot be recommended for screening of general populations.


Author(s):  
LAUREL K. LESLIE ◽  
JILL WECKERLY ◽  
JOHN LANDSVERK ◽  
RICHARD L. HOUGH ◽  
MICHAEL S. HURLBURT ◽  
...  

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S38-S38
Author(s):  
Silvia Molteni ◽  
Giulia Spada ◽  
Eleonora Filosi ◽  
Martina Maria Mensi ◽  
Elena Ballante ◽  
...  

Abstract Background The identification of people at high risk of developing psychosis is one of the most promising strategies to improve outcomes. However, in children and adolescents research on the high risk state and attenuated psychotic symptoms is still in its infancy and the clinical validity of at risk criteria appears understudied in this population (Tor et al. 2018). Thus, in this longitudinal cohort study, we aimed to: (1) characterize the clinical profile of APS adolescents, adolescents suffering from early onset psychosis (EOP) and adolescents with psychiatric disorders other than APS and EOP (non-APS) and (2) to calculate the cumulative transition rate to psychosis at follow-ups and investigate predictors of conversion to psychosis. Methods Help-seeking adolescents (aged 12–18 years) consecutively admitted to Child and Adolescent Neuropsychiatric inpatient and outpatient units of the IRCCS Mondino Foundation (Pavia, Italy) were recruited. The Comprehensive Assessment of At-Risk Mental State (CAARMS) was used in order to evaluate the presence of attenuated or full-blown psychotic symptoms. The final sample consisted of 31 EOP, 110 APS and 102 non-APS adolescents. At baseline patients underwent an extensive clinical and, in a subset, also neuropsychological assessment using standardized semi-structured interviews and instruments. All APS patients recruited until March 2019 were followed up for a median period of 33 months (range 4–81 months) and baseline measures were repeated (every 12 months). Transition to psychosis was defined according to the CAARMS criteria. Results At baseline, APS status was associated with poor socio-occupational functioning, especially social functioning (p<0.0001), as well as clinical severity (p<0.0001) as assessed by clinicians. APS adolescents reported a higher level of suicidality compared to non-APS (p=0.0003). The APS group displayed a higher number of comorbid disorders compared to the EOP and non-APS (p<0.0001) and was related to a wide range of disorders. APS and non-APS adolescents did not significantly differ in any of the neuropsychological test administered, although a worsening trend was observed between the two groups with lower scores in APS adolescents. The cumulative proportion of psychosis transition in the APS group was 13%, 17%, 24.2% and 26.8% at 1,2,3 and 4-year follow-ups, respectively. A high percentage of APS patients received at least one psychotropic medication (62.1%) during the follow-up period, especially antipsychotics (43.7%). Baseline lower global and social functioning (p=0.0092), higher clinical severity (p<0.0001), negative symptoms, lower Total IQ (p=0.02) and Processing Speed Index (p=0.03) were associated with transitioning to psychosis at follow-ups. Discussion Our findings support the validity and clinical relevance of the identification of APS in children and adolescents. Indeed, in our sample APS adolescents suffer from a variety of comorbidities and non-psychotic symptoms, present higher suicidality and are markedly impaired compared to non-psychotic adolescents not fulfilling APS criteria. Moreover, they show a cumulative transition risk to psychosis of 26.8% at 4 years that, although being lower than that found in adult samples, is still comparable to that of other conditions in preventive medicine.


BMJ Open ◽  
2013 ◽  
Vol 3 (9) ◽  
pp. e003206 ◽  
Author(s):  
Gemma Hammerton ◽  
Gordon Harold ◽  
Anita Thapar ◽  
Ajay Thapar

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