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NCT06352372
For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or with epilepsy. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.
NCT07439276
In France, more than one in ten school-aged children suffers from a mental health disorder, and half of these disorders appear before the age of 14. Yet, only half of affected children receive appropriate support. At the cognitive level, it is now widely accepted by the scientific community that strong socio-cognitive skills protect against the emergence of certain disorders. Social cognition skills, crucial for development and social integration, are often underestimated in clinical neuropsychology, particularly due to the lack of validated assessment tools for children. The challenges related to the clinical assessment of social cognition in children and adolescents are therefore significant, especially since specific deficits are likely to be associated with numerous developmental pathologies and psychiatric disorders (neurodevelopmental disorders, mood disorders, anxiety disorders, psychotic disorders). However, these disorders are insufficiently assessed. A more precise characterization would allow for the identification of therapeutic targets specific to each neurodevelopmental disorder. Therefore, this research aims to address this lack of tools by using a multidimensional assessment battery of social cognition in children and adolescents aged 8 to 16, evaluating four fundamental domains of social cognition: emotion processing, social perception, theory of mind, and attributional style. This multidimensional assessment battery of social cognition is developed by the Child and Adolescent Psychiatry Department of Necker-Enfants Malades Hospital.
NCT03023293
This study aims to investigate the associations of maternal nutritional status during pregnancy and postpartum periods with postpartum abnormal glucose metabolism in Guangzhou pregnant women. Additionally, it seeks to explore the relationships between maternal nutritional status (pre- and postnatal) and offspring health outcomes, including physical growth, neurodevelopment, and common childhood diseases.
NCT06915480
There are four goals of this project: (1) To examine the impact of different appointment reminder messages on appointment attendance; (2) to determine the added benefit of a patient navigator reaching out in advance of appointments to families at elevated risk of missing their appointment, and determine the most common barriers families face in appointment attendance; (3) to evaluate which patients are at highest risk of missing their appointment, and to determine the effectiveness of the intervention trial across different patient risk levels; and (4) to examine if the missing appointment interventions increase the socioeconomic diversity patients.
NCT04505072
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.
NCT07387627
The purpose of this clinical trial is to evaluate whether the COPCA® program (Coping with and Caring for Infants with Special Needs) is more effective than conventional pediatric physiotherapy and parent education in improving development in infants at risk of neurodevelopmental disorders, as well as empowering their families. This study will include infants younger than 12 months of corrected age who are at risk of neurodevelopmental disorders and are currently receiving early intervention or pediatric physiotherapy services, together with their parents or primary caregivers. The main questions this study aims to answer are: Does the COPCA® program improve motor development and functional abilities in infants at risk of neurodevelopmental disorders more than conventional pediatric physiotherapy or parent education? Does the COPCA® program increase family empowerment and improve parents' perception of the care they receive compared with traditional intervention models? The researchers will compare outcomes across four study groups: In-person COPCA® intervention Online COPCA® intervention Parent education group Conventional pediatric physiotherapy group Participants will be randomly assigned to one of the four groups. The intervention period will last 6 months, with assessments conducted at the start of the study, during the intervention, and during follow-up. Infants will take part in age-appropriate daily activities and play situations. Parents or caregivers will actively participate in the intervention sessions and will be supported in learning how to promote their child's development during everyday routines. The study will assess infant motor development, functional abilities, overall development, family empowerment, and parents' perception of family-centered care using validated assessment tools and interviews. The results of this study may help improve early intervention strategies for infants at risk of neurodevelopmental disorders and support more family-centered approaches to care.
NCT03770832
The objective of this study is to develop an automated, precise, quantitative assay for detecting atypical motor behavior and development in infants using data from wearable sensors and video recordings.
NCT07353112
The aim of this study is to validate the French version of the SOSI-M test on healthy children as well as on children with neurodevelopmental disorders (NDDs). Therefore, the investigators will conduct a video recording of the test administration on a group of healthy children and on a group of children with NDDs. The research question is: Is the French translation of the SOSI-M test equivalent, in terms of functionality and expected results, to the original version for a population of healthy children and children with mild to moderate neurodevelopmental disorders? The hypothesis is that the psychometric properties of the French version are similar to those of the original version. Secondly, the investigators will investigate: Does the difference in socio-cultural context between healthy Belgian and Senegalese children influence the SOSI-M score? The hypothesis is that healthy Belgian children obtain better scores compared to healthy Senegalese children. The scores of the two groups will be compared with each other and with those obtained in previous studies. Intra- and inter-rater reliability will also be assessed.
NCT07330336
In France, the rate of labor induction has markedly increased in recent years, partly following the ARRIVE trial suggesting short-term benefits of elective induction at 39 weeks in low-risk nulliparous women. This trial is currently being replicated in France (FRENCH-ARRIVE), as maternal characteristics, cesarean rates, and healthcare organization differ from the US. Importantly, no comparative data exist on the mid-term consequences of reducing gestational age at delivery with elective induction of labor-from 41 to 39 weeks-versus usual expectant management on child health and maternal outcomes. Generating such evidence is essential to inform decision making for women reaching 39 weeks of gestation, i.e. the large majority of pregnant women
NCT07323004
On the one hand, it helps to understand the motor development of preschool children, so as to provide early intervention means for the prevention of motor retardation and promote the healthy development of preschool children, and on the other hand, different motor intervention strategies are formulated according to the developmental characteristics of children with different core symptoms. It is of great academic value to verify the effectiveness of the program through empirical research on exercise intervention and promote the improvement of motor and cognitive development of children with neurodevelopmental disorders.
NCT04096430
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.
NCT03492060
The purpose of this study is to analyze patterns in individuals with hnRNP (and other) genetic variants, including their neurological comorbidities, other medical problems and any treatment. The investigators will maintain an ongoing database of medical data that is otherwise being collected for routine medical care. The investigators will also collect data prospectively in the form of questionnaires, neuropsychological assessments, motor assessments, and electroencephalography to examine the landscape of deleterious variants in these genes.
NCT06649916
The overall objective of this research is to determine whether parentese delivered in the video format (Aim 1) and in live interaction (Aim 2) facilitates novel word learning in autistic children and to investigate if there are factors that influence the effect of parentese on word learning (Aim 3).
NCT06431269
Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease
NCT07159360
Neurodevelopmental disorders often result in abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as the inability to stand and walk. CLINICAL EXPLORER is a clinical-use robotic device for gait training, representing the evolution of the ATLAS 2030 exoskeleton and the EXPLORER device for home use. The aim of this study is to evaluate the safety and usability of CLINICAL EXPLORER .
NCT05584059
This study aims to determine the feasibility, acceptability and potential efficacy of an individual, video-conferencing based Focused Acceptance and Commitment Therapy (FACT) on the mental well-being of parents of children with Special Health Care Needs(SHCN). The study also aims to explore the experience of parents after participating in the individual-based FACT sessions offered by the trained FACT interventionists.
NCT06869915
Introduction \& Central question: Psychiatric disorders are highly prevalent in the homeless population, however neurodevelopmental disorders are also at risk of leading to homelessness (Churchard et al., 2018; Casey et al., 2020). Research on this topic is poor in France. This research aims to study the prevalence in France of 3 neurodevelopmental disorders (NDDs) in a homeless population (Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder and Intellectual Developmental Disorder). Methods / approach: A 2 phase approach will be used including a screening phase and a diagnosis phase. This research is a pilot study that will include 150 homeless people, over 2 years. The assessment involves combining the results from standardised self-report tools, direct observation and informant-report, thus guaranteeing an objective and thorough diagnosis. This approach gives a better picture of actual behaviour but also a better understanding of the person's development. OUTCOME: This study will give insight on how to better understand the profile of the homeless population in France, and the prevalence of autism in this population. It will also bring valuable knowledge on how autism and other NDDs can impact one's path in life and lead to homelessness. The results can help develop targeted cares and measures for homeless people with NDDs.
NCT06175104
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.
NCT03977259
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.
NCT05815095
This study aims to compare two screening strategies for identifying infants with a potential risk of Autism Spectrum and Neurodevelopmental Disorders to provide early access to care and increase the likelihood of a favorable outcome