View clinical trials related to Neurodevelopmental Disorders.
Filter by:This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD (Part 1) and MAD (Part 2)) and food effect (FE) of RO6953958 following oral administration in healthy male participants. Part 3 (Drug-drug interaction (DDI)) will assess the safety, tolerability, and effect of RO6953958 on the PK of the cytochrome P450 (CYP) 3A substrate midazolam.
There is a long-standing assumption that physical activity is an effective, non-pharmacological approach to improving sleep quality and quantity. However, objective and reliable data on this relationship are scarce for children with developmental disabilities. Parent burnout in this population is high and there are many barriers to engagement with such interventions. This study aims to understand the feasibility of providing an exercise intervention for this population, and gathering parental views on the impact of such an intervention. Depending on the outcome of this feasibilty study, larger scale interventions may be planned to further examine the impact of such an intervention.
There is not a lot of research focusing on Black and African American families raising young children with developmental delays. While the investigators know that early intervention helps children and their families, Black children with developmental delays are less likely to access such services. The causes for these racial disparities are largely unknown. Researchers have recommended caregiver support programming while on waitlists to improve caregiver-provider interactions and caregiver knowledge of the diagnostic process and developmental delays. Once a child is referred to a clinic for developmental concerns, long appointment waitlists contribute to further delays in timely diagnosis and treatment, as well as parental distress. Support programs for waitlisted families can begin to address these challenges. In this study, the investigators will examine a program called Parents Taking Action with families on a waitlist for a specialty developmental evaluation. The investigators will study if the program is feasible in this setting, if participants like the program, and if child and parent outcomes improve after participants have completed the program.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with characteristic deficits in social functioning and presence of stereotypic behavior. Several research studies have examined potential deficits in cognitive skills, such as working memory, in this condition. A meta-analysis of the studies aimed at evaluating working memory (WM) in autistic population suggested deficits in visual and verbal aspects of WM. Working memory training has also been studied in other neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD). The study includes development of mobile-based games for training WM and other cognitive skills in patients and the evaluation of such training in reducing symptoms of ASD. These games may also be useful for other neurodevelopmental disorders.
The aim of the study is to examine the prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years.
This is an observational case-control add-on study to an investigator-initiated clinical trial (IICT) (ClinicalTrials.gov Identifier: NCT03167307): Omega-3 fatty acids as firstline treatment in pediatric depression. A 36-week multi-centre, double-blind, placebo-controlled randomized superiority study. This project will recruit a healthy control group matched for age and sex to a sub-group of patients with diagnosed pediatric major depressive disorder (pMDD) enrolled in the IICT. The aim is to investigate the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD, and explore potential biochemical mechanisms underlying this relationship by measuring biomarkers related to n-3 FA metabolism, mental health and cognitive function.
Organizational, time management and planning (OTMP) skills deficits are impairing features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD), which compromise school performance and family relations. The manualized Organizational Skills Training program (OST) was designed to target children's specific OTMP deficits. However, the brain mechanisms of treatment-induced changes remain unknown. The current study combines a training intervention (OST) with non-invasive MRI imaging in a pre-/post-design in a randomized two-arm (treatment vs. waitlist) trial to address this question.
The Huizhou mother-infant cohort was set up to investigate the effect of dietary factors and environmental exposures during pregnancy on health consequences of mothers and offsprings in Huizhou, China.
The purpose of this study is to assess whether the type of anesthesia, narcotic-based versus inhalational anesthesia administered during cardiopulmonary bypass (CPB) surgery contributes to the wide variation in neurologic recovery and developmental outcome after surgery in infants with congenital heart disease.
The aim of this study is to optimize an adapted version of a parenting program, Parenting for Lifelong Health for Young Children (PLH), to meet the specific needs of families in three low- and middle-income countries in Southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova) using a cluster factorial experimental design to select the most efficacious, cost-effective, and scalable intervention components. This study is the second phase of a three-phase research project (www.rise-plh.eu). The cluster factorial experiment will examine the effectiveness, cost-effectiveness, and implementation of three selected components of the PLH for Children program to inform the selection of the most effective, cost-effective, and implementable components to include in a prevention package prior to testing it in a subsequent RCT. The cluster factorial experiment will be conducted across three Southeastern European country sites. Each site will recruit families with children aged two to nine years who have elevated levels of child behavior problems, including specifically high-risk groups, such as minorities (e.g. Roma families). Program facilitators will be recruited from local agencies and schools. The factorial experimental trial will randomize 16 clusters in each country to one of 8 experimental conditions which consist of any combination of the three components (program length: 5 sessions/10 sessions; engagement booster: high/low; fidelity booster: high supervision/low supervision). The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components. At the end of the cluster factorial experiment, we will develop an optimized version of the program by selecting components or component levels that have the highest level of effectiveness as based on effect size (rather than p-values). We will also take into consideration factors regarding cost-effectiveness and implementation outcomes when designing this optimized intervention package.