Active clinical trials for "Neurodevelopmental Disorders"

There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melatonin secretion and melatonin administration has been shown to be effective in these populations. For children who have difficulties swallowing a tablet, Neurim has developed an age-appropriate Melatonin formulation in the form of mini-tablets which have the same dissolution profile as the Circadin® tablets product, thus should produce the same melatonin concentration-time profile with the same effects. This study concerns the pharmacokinetic study. The purpose of this study is to : Establish the 24 hour baseline profile of endogenous saliva melatonin concentrations and urine 6-SMT excretion in children aged 2 up to and including 17 years with neurodevelopmental disorders with sleep disturbances. Establish the concentration-time profile of saliva melatonin concentrations and 24 hour 6-SMT urine excretion after 2 and 10 mg Circadin® mini-tablets single dose administration in children aged 2 up to and including 17 years with neurodevelopmental disorders with sleep disturbances. Evaluate the adverse event profile after a single dose of 2 or 10 mg Circadin® mini-tablets in children aged 2 up to and including 17 years with neurodevelopmental disorders with sleep disturbances.

The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding, and feeding performance in preterm infants.

Maternal nutrition is an important factor which determines fetal growth and development. Micronutrients vitamin B12 and folic acid are essential determinants of one carbon metabolism and play an important role in DNA synthesis, methylation and epigenetic regulation of gene expression. Diabetes unit of KEMHRC, Pune has been conducting the Pune Rural Intervention in Young Adolescents since last 3 years. Subjects of the PMNS cohort have been randomized as part of a controlled trial of nutritional intervention with vitamin B12 vs multiple micronutrient and milk protein vs placebo. This study aims to understand the intergenerational effects of vitamin B12 supplementation. 74 infants have been born in this trial since 2013. This study would assess neurocognitive development of offspring born to mothers who are part of the nutritional intervention trial; on the Bayley scales of infant and toddler development - III. The study aims to test the hypothesis that infants born to mothers who received vitamin B12 would have favorable infant neurocognitive development scores as compared to placebo. And this effect would be enhanced in the group whose mothers received MMN with milk protein.

The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili). The intervention, delivered by lay counselors and through existing community social structures, is expected to improve family functioning and individual mental health among members. The sample includes highly distressed families with a child or adolescent (ages 8-17) exhibiting emotional or behavioral concerns; as such, particular emphasis is placed on adolescent-focused outcomes, including mental health and well-being.

Behavioral and emotional disorders adversely affect overall health and well-being. Prevalence rates among children and adolescents classified with behavioral and emotional disorders or neurodevelopmental disorders (NDD), as recently redefined in ICD-11, have steadily increased over the past decade. In particular, prevalence rates among persons classified with Autism Spectrum Disorders (ASD), the fastest rising behavioral and emotional disorder, have sharply risen over the past five years and is now estimated at 1 in 54. Shared symptoms within behavioral and emotional disorders include persistent social, emotional and behavioral functioning deficits that often impact self-management, social-awareness and metacognition competences, in addition to adulthood health and wellness life course transition management. Social and Emotional Learning (SEL) stakeholder advocates have contributed meaningfully to the strengthening of behavioral and emotional health through interventions that focus primarily on physical and mental health outcomes of diagnosed individuals. However, focus on spiritual health outcomes and the at-risk population remain largely underutilized. Research that seeks to employ an integrative physical-mental-spiritual approach to strengthen social, emotional and behavioral resilience, of at-risk school age populations where social stigma and prohibitive treatment costs remain barriers to treatment is needed to help expand the field's understanding of the reciprocal relationship between spiritual health and emotional and behavioral outcomes. The RENEW (Resilience in Emotional and Behavioral Wellbeing) intervention will employ a multidisciplinary approach of social and emotional learning competency training, gamification principles and faith-centered values to strengthen social, behavioral and emotional resilience and competencies of those at risk for behavioral and emotional disorders, via a child-as co-researcher approach.

The study aims to implement and evaluate an RCT of behavioural sleep interventions for children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to address the following questions: To what extent can a behavioural intervention improve sleep difficulties and increase sleep duration in children with ADHD? To what extent do intervention-induced changes in sleep for children or primary caregivers (women) account for any changes in ADHD symptoms?

This trial will pilot test intervention strategies to increase utilization of HIV testing and gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV sexual transmission in the general population in Russia. The study will assess whether external (cost, convenience) or internal factors (low perception of own risk, reluctance to identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested and if peer support impacts their decision. A randomized experimental manipulation, comparing opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed by a second-chance testing offer will be used to inform these questions. The answers will enable the international research team to engineer and then test an HIV testing promotion strategy in Russia. The project will collect preliminary data for a larger study to develop an evidence-based program to reduce the HIV transmission in this high risk population.

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.

Mental health consequences of the COVID-19 pandemic may be vast and may potentially overwhelm the mental health system in a long-lasting manner. Evaluating the effects of the COVID-19 pandemic on mental health in vulnerable groups such as children and adolescents has become an immediate priority. The aim of this study is to evaluate the impact of COVID-19 pandemic on use of mental health resources namely 1) prescriptions of psychotropic medications and 2) mental health-related outpatient visits, hospitalizations and emergency department visits in children and adolescents in France. Secondary aim is to evaluate the impact of the pandemic on episodes of fatal and non-fatal self-harm episodes in the same population. This will be a population-based cohort study using data from healthcare claims, administrative medical and outpatient drug dispensation databases in France between January 1, 2016 and June 1, 2021. Findings will inform on the risk of upcoming outbreaks of mental disorders that can result in significant morbidity and mortality and guide timely targeted actions to improve mental health outcomes and wellbeing in the youngest.

This study is about early intervention for preschool children with emotional and stress related disorders. To develop a set of program that could be used in district hospitals for early intervention of preschool children with emotional and stress related disorder or problems.