View clinical trials related to Neurodevelopmental Disorders.
Filter by:Background: During the first few decades of life, the brain changes dramatically in shape and function. Sleep lets researchers measure these changes. Researchers want to create a database of sleep and neurodevelopmental data in a group of infants and children to learn more. Objective: To address a knowledge and data gap in the field of sleep and neurodevelopment in infants and children. Eligibility: Children ages 6 months to 76 months who may or may not be at risk for neurodevelopmental and neuropsychiatric disorders. Also, children ages 6 months to 8 years who have a referral for a sleep study. Design: Participants will have neurodevelopmental testing. They will have a medical, psychiatric, and family history. They will have a physical and neurological exam. They will be interviewed and complete surveys. They will give a cheek swab and/or blood sample. Some participants will have 1 study visit that lasts 2 days. Other participants will have up to 4 study visits. Each visit will last 2 days. Visits occur every 8 months to 1 year, for a total participation time of 2 years. Participants will have a 20-minute daytime electroencephalogram (EEG), if possible. This EEG session will be used to calibrate the machine for the overnight study. Participants will take part in an inpatient overnight sleep study. Electrodes will be placed on the participants. For young children, parents will help place the EEG leads. Other sensors may also be placed. A gauze cap will be placed on participants head to protect the leads and keep the participants from moving them. 'Lights out' will occur as close to participants bedtime as possible. ...
Randomized controlled trial of PR-ESSENCE treatment for youth with challenging behavior in two youth treatment homes, including 60-70 youth. Inclusion criteria: Youth aged 12-17 years, staying at least 3 months at the home, with intellectual function in the normal range according to WISC-test and clinical judgment, and exhibiting significant problem behaviors as measured by Broset Violence Checklist (BVC). Subjects are randomized to 10 weeks of PR-ESSENCE treatment or to the control condition "treatment as usual". After the control period, the control group will receive 10 weeks of PR-ESSENCE treatment. Outcome is assessed at baseline, post-treatment/control period, and 3-6 months post-treatment (at the time when the youth is planned to move from the home) with global assessments of problem severity and improvement by blinded rater (CGI-I, CGI-S), ratings of SNAP-IV (ADHD and oppositional symptoms), ECBI (behavior problems) and RPQ (relation problems) by the youth's contact person, and self-ratings of psychiatric symptoms and self-concept with Becks Youth Inventories. BVC ratings are also made daily by contact persons and teachers during the whole study.
Early childhood detection of motor delays or impairments provides the opportunity for early treatment which improves health outcomes. This study will use state of the art sensors combined with machine learning algorithms to develop objective, accurate, easy-to-use tools for the early scoring of deficits and lays the foundation for the early prediction of physical disability.
Background: Suicide is the second leading cause of death for young people ages 10-24 years. There is no gold standard for evaluating suicidal thoughts and behaviors in young people with autism spectrum disorder (ASD) or other neurodevelopmental disorders (NDD). Also, youth with ASD/NDD are often excluded from many research studies. Because of this, researchers need more data. They want to make sure they are asking the best questions for young people in clinics such as the National Institute of Mental Health (NIMH) clinic. They want to make sure they have the best data to determine if a person is at risk for hurting or killing himself or herself. Objective: To develop and assess the efficacy of a suicide screening tool for people with ASD/NDD. Eligibility: Youth ages 8 to 17 who are engaged in assessment or treatment at the NIMH for ASD or other NDD Design: Participants will fill out 4 questionnaires during a 1-hour meeting with study staff. They will answer questions about how they have been feeling. They will be asked if they think about or plan to hurt or kill themselves. They will also be asked if they have ever thought about it or planned it in the past. Other questions will assess their understanding of death. Participants can take a break if needed. Parents of the participants will be asked similar questions. Parents will be informed if their child has current thoughts of suicide. About 1 week after the initial assessment, parents will be contacted to fill out a follow-up questionnaire. It will take about 10 minutes to complete.
Background: Congenital heart disease (CHD) is the most frequent inborn defect with an incidence of 1 in 100 newborns per year, i.e. 800 children born in Switzerland per year. 10% to 15% of cases are born with single ventricle (SV), the most complex type of CHF requiring immediate surgical intervention after birth. Infants with SV CHD are treated in three surgical staged procedures over the first three years of life. However, cerebral injuries occur in around 40% of those children and impact neurocognitive abilities. As more than 90% of all infants with CHD survive to adulthood, scientific concern is focussed on patient-individual course brain growth and development within the relative contribution of fetal, perinatal, cardiac and surgical risk factors. Therefore, serial cerebral MRI examinations are needed, starting (1) at the third trimester during fetal life proceeding to (2) pre- and postoperative time points at the stage I surgery after birth and (3) before stage II surgery at 4 months of age. We will compare the cerebral MRI findings with a healthy control population, recruited at the same time points, and correlate brain growth and development with the neurodevelopmental outcome assessed at one year of age. Three Pediatric Heart Centers in Switzerland and Germany will participate. The overall aims are: 1. To analyse the patient-individual cerebral developmental trajectories, brain growth and determine the time course of brain abnormalities in infants with single ventricle CHD by serial cerebral MRI during fetal life, after birth and at an age of 4 months (primary endpoints). 2. To determine the neurodevelopmental outcome at one year of age using the Bayley III and will be correlated with the brain growth and brain development in the third trimester of fetal life and at the age of 4 months (secondary endpoints). 3. To analyse fetal, neonatal, surgery-related and intensive care associated factors determining the patient-individual course for altered cerebral growth and impaired neurodevelopmental outcome at one year of age. Methodology: We will prospectively enroll fetuses and neonates with single ventricle CHD at the three Pediatric Heart Centers in Switzerland (Zurich, Bern) and Germany (Giessen). Advanced MR imaging will assess cerebral volumes, microstructural and hemodynamic changes at repeated time points during the third trimester of fetal life (32. week of gestation), the perioperative neonatal period before and after stage I surgery and before stage II surgery at 4 months of age. Biomechanical analysis of longitudinal changes of brain morphology will be applied to longitudinal fetal and neonatal MRI data. Outcome is determined with the Bayley-III at one year of age. Significance: Using a population-based sample of children with single ventricle CHD, we will be able to determine cerebral growth from the third fetal trimester until the first 4 months after birth, when the brain is most rapidly growing. By performing serial brain imaging, the knowledge of etiological pattern affecting cerebral growth, development and brain injury will increase. Morphometric and biomechanical analysis of brain growth patterns will be performed that may capture fine-grained changes associated with CHD. By correlating these data with the neurodevelopmental outcome at one year of age it will be possible to identify specific risk constellations leading to impaired brain development and categories of brain injuries that confer a higher risk of adverse outcome. The better understanding of the pathophysiological mechanisms will serve as the basis for neuroprotective studies and pharmacological trials aiming to improve outcomes in children with CHD in the future.
This study aims to test the feasibility of implementing an Icelandic cognitive-behavioral program designed to prevent depression, called "Thoughts and Health" in a Swedish school setting. The investigators will also evaluate whether implementation of the program has an impact on the participating students, regarding both their mental health and their success in finishing junior high school with passing grades.
Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. Service use and the cost vs. benefits of the ENGAGE approach compared to usual practice will also be examined. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites in Alberta, Canada will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. This study will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. After the study, children, parents and therapists will be asked to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve efficiency of paediatric rehabilitation services.
Anti-epileptic drugs (AEDs) are potent teratogens associated with a spectrum of physical and neurodevelopmental anomalies to the exposed fetus. Particular risks include congenital malformations, impaired motor and cognitive functioning, autism and poorer educational attainment. Fetal exposure to drugs that bind to central nervous system targets as part of their therapeutic effect (e.g. neurotransmitter receptors and neuronal channels) appear to alter brain structure and function in both animal models and humans. Fetal magnetic resonance imaging offers an approach to investigate these effects in vivo, identifying biomarkers, defining the onset of abnormalities and dose response. Fetal MRI may offer risk stratification and identify patients that may benefit from intervention early in development. The overall aim of this study is to contribute to improving developmental outcomes following the inevitable exposure during treatment of maternal epilepsy. This novel study aims to explore the central nervous system with state-of-the-art non-invasive multimodal magnetic resonance imaging consistent with the University of Nottingham Precision Imaging Beacon, so as to improve outcomes in patients at risk of long term complex neuropsychiatric conditions.
Nearly one in five children in the United States has a mental health problem that interferes with daily functioning and requires intervention, and yet less than 50% of children who need mental health care receive any services. Families and especially from low-income and ethnically diverse backgrounds, experience a range of barriers to engaging in services for their children including: lack of recognition of problems and knowledge of available treatments, connecting to services, trust in providers, stigma; low income and ethnically diverse populations are especially affected by these barriers. In this work, the investigators propose to carry out initial testing of a research- and theory-based model of Parent Peer Navigation services to help engage families with children with significant but pre-clinical problems in mental health services in order to prevent future poorer outcomes for children, who otherwise may never receive services, or only receive services when their mental health issues become severely debilitating for themselves and their family.
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.