Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting.

INTRODUCTION: Attention deficit hyperactivity disorder (ADHD) affects 5%-10% of paediatric population and is reportedly more common in children with type 1 diabetes (T1D), exacerbating its clinical course. Proper treatment of ADHD in such patients may thus provide neurological and metabolic benefits. To test this, we designed a non-commercial second phase clinical trial comparing the impact of different pharmacological interventions for ADHD in children with T1D. METHODS AND ANALYSIS: This is a multicentre, randomised, open-label, cross-over clinical trial in children and adolescents with ADHD and T1D. The trial will be conducted in four reference paediatric diabetes centres in Poland. Over 36 months, eligible patients with both T1D and ADHD (aged 8-16.5 years, T1D duration >1 year) will be offered participation. Patients' guardians will undergo online once-weekly training sessions behaviour management for 10 weeks. Afterward, children will be randomised to methylphenidate (long-release capsule, doses 18-36-54 mg) versus lisdexamphetamine (LDX, 30-50-70 mg). Pharmacotherapy will continue for 6 months before switching to alternative medication. Throughout the trial, the participants will be evaluated every 3 months by their diabetologist and online psychological assessments. The primary endpoint (ADHD symptom severity, Conners 3.0 questionnaire) will be assessed by a blinded investigator. Secondary endpoints will include HbA1c, continuous glucose monitoring indices and quality-of-life (PedsQL). ETHICS AND DISSEMINATION: The trial is approved by Bioethical Committee at Medical University of Lodz and Polish regulatory agency (RNN/142/22/KE, UR/DBL/D/263/2022). The results will be communicated to the research and clinical community, and Polish agencies responsible for healthcare policy. Patient organisations focused on paediatric T1D will be notified by a consortium member. We hope to use the trial's results to promote collaboration between mental health professionals and diabetes teams, evaluate the economic feasibility of using LDX in patients with both diseases and the long run improve ADHD treatment in children with T1D. TRIAL REGISTRATION NUMBERS: EU Clinical Trials Register (EU-CTR, 2022-001906-24) and NCT05957055.

Validation and psychometric evaluation of the Polish version of the FCV-19S in children and adolescents. / Walidacja polskiej wersji skali FCV­19S oraz jej wlasciwosci psychometryczne w populacji dzieci i mlodziezy.

OBJECTIVES: The COVID-19 pandemic might have impacted the psychological well-being of children and adolescents in Poland. The epidemiological situation is constantly changing and it is difficult to predict its further course. There are ongoing discussions about the possible benefits and consequences of children returning to school. For this reason, it is justified to develop a Polish version of an uncomplicated and easy-to-use diagnostic tool for fear assessment, which will enable the identification of children requiring special psychological support. The aim of the study was to develop the Polish adaptation of the recently published Fear of COVID-19 Scale and to examine the psychometric properties of the Polish version among the population of children and adolescents. METHODS: The sample included 167 participants aged 10 to 17 years. On-line surveys were conducted in three groups - patients with a psychiatric diagnosis, students and children from group homes. RESULTS: The analysis of the collected data showed that the Polish version of the FCV-19S has good psychometric properties. Confirmatory factor analysis confirmed the one-way structure of the scale. The reliability of the total score proved satisfactory (Cronbach's α = 0.831). In addition, group comparison analyzes showed that children from group homes reported highest fear of coronavirus. CONCLUSIONS: Our results suggest that the Polish version of the FCV-19 Scale is a valid and reliable tool which can be used in the psychological assessment of the severity of fear of COVID-19 among children and adolescent.

The impact of the COVID-19 pandemic on the mental health of children with psychiatric diagnoses - multidimensional CCPCA Model.

BACKGROUND: The study aimed to assess the severity of symptoms of anxiety and depression in children with previously diagnosed psychiatric disorders during the COVID-19 pandemic in Poland. METHODS: Online questionnaires were used to investigate three groups of subjects: patients with a psychiatric diagnosis, primary school pupils, and children from children's homes. A total of 167 children with their parents or guardians participated in the study. In addition to basic statistics, a multidimensional Centroid Class Principal Component Analysis (CCPCA) model was used. RESULTS: It was found that the strongest fear of the coronavirus was experienced by children from children's homes, while the most severe depressive symptoms and state anxiety were observed among patients diagnosed with psychiatric disorders. Parental care by assisting with school education and lack of close contact with other people (less than two metres) at parents/guardians' work had the most potent protective effect in reducing the fear of COVID-19. CONCLUSIONS: There is a need for further research in children and adolescents to develop effective strategies for protecting their mental well-being when faced with social isolation or disease.

Gut microbiota and probiotic therapy in ADHD: A review of current knowledge.

Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention, impulsivity and hyperactivity. The etiology of the disorder is multi-factorial, with a main focus on genetic factors. However, emerging research shows the involvement of changes and imbalances in the intestinal microbiota. Evidence for the influence of gut microbiota on brain development and neurogenesis is clear. We present a review of emerging research on the microbiota in the ADHD population. The aim of this study was to summarize the current state of knowledge on ADHD, to identify gaps in knowledge, as well as to indicate the directions of new research. Thanks to the researchers that would be possible to better understand the complexity of ADHD etiology, especially the role of the intestinal microbiota in the pathogenesis of the disorder. Pubmed, Scopus and Google Scholar databases were used while writing the review. Numerous studies show that probiotic supplementation can have a positive effect on the course of neurodevelopmental disorders, including ADHD. Unfortunately, clinical studies that were identified are mostly inconclusive, and more high-quality research is needed to produce robust evidence for therapy based on interventions targeting microbiota.