Active clinical trials for "Neurodevelopmental Disorders"

The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.

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.

This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the PICU of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016. A link to a questionnaire including the Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment as well as question on current impairments and health, will be sent to parents. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided.

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.

The overall RISE project aims to adapt, optimise and test a low-cost parenting programme for families in three southeastern European countries (North Macedonia, Republic of Moldova, Romania). Therefore, the investigators apply the Multiphase Optimization Strategy (MOST) and conduct the study over 3 phases: during the first Phase (Preparation) the feasibility of the intervention and the assessment and implementation procedures were tested in a small pilot study. In the second Phase (Optimization), 8 different programme combinations were tested in order to identify the most effective and cost-effective combination in the three countries. Now, in the third Phase (Evaluation), the optimised intervention identified in Phase 2 will be tested in a randomised controlled trial. The investigators also apply dimensions of the RE-AIM framework to maximise the reach, effectiveness, adoption, implementation within the existing service infrastructure and maintained use of the new intervention. For the current Phase 3, the investigators aim to recruit a total of 864 parents (n = 288 per country) of children with elevated child behaviour problems aged 2 to 9 years. After pre-assessment the families will be randomly assigned to the intervention group or the control group. Parents in the intervention group will receive a parenting programme (5 sessions, Parenting for Lifelong Health for Young Children, PLH-YC) and the parents in the control condition will receive one lecture on parenting (Raising Healthy Children). Parents will be asked to complete assessments after intervention completion (post-assessment) and 12 months after pre-assessment (follow-up assessment) in order to detect immediate and more longterm effects.

Six-years following participation in the Family Bereavement Program (FBP) participants in the program as compared to a self-study control group will have lower levels of mental health problems, lower one-year prevalence of mental disorder that meets diagnostic criteria, lower use of substances, higher levels of competence at achieving developmentally appropriate tasks in academic achievement and social competence, and better self-esteem. The effects of the FBP will be moderated by baseline levels of mental health problems and gender. Bereaved caregivers who participated in the program will also show lower levels of mental health problems as compared with controls. Program effects will be mediated by theoretical mediators targeted by the program.

The study aims to evaluate the effectiveness of the transdiagnostic program Super Skills for Life (SSL). This protocol targets children aged 8 to 12 with emotional problems (anxiety, depression, low self-esteem, and lack of social skills). SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits, and coping strategies. The present research focuses on assessing the effectiveness of SSL applied online (through a virtual platform).

This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome in Russian children through development of printed FAS education materials targeting women of childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. The rates of FAS and Alcohol Related Neurodevelopmental Disorders (ARND) in Russia are not precisely known. At this time, there are no programs to prevent FAS in Russia. The results of our previous study, focus groups with health professionals, pregnant women and their partners, non-pregnant women, and women with alcohol dependency, indicated limited knowledge about FAS, misconceptions about alcohol use during pregnancy, and a lack of materials and print resources related to this topic. Based on the initial findings, this proposal aims to develop and evaluate in a clinical trial informational brochures for women to increase knowledge and reduce drinking during pregnancy in Russia. The main hypotheses to be tested are: 1. Compared to the control group (CG) of women who receive a standard locally available flyer with health recommendations, women in the experimental groups who are exposed to printed information on FAS will show significantly more knowledge about FAS, significantly less acceptance of any alcohol use during pregnancy, and reduced drinking at one month follow-up assessment. 2. The group exposed to a brochure with negative images (IGN - Intervention group with a "negative brochure") regarding drinking during pregnancy will show significantly greater change in the predicted directions compared to the group exposed to positive images (IGP - Intervention group with a "positive" brochure) at the one month follow-up assessment.

Objective: To evaluate the effect of Iron supplement with two different amounts (one in the higher limit and another in the lower limit of the suggested amount) according to the presence of mutations in the HFE gene in the physical, immune and neurobehavioral development in the 6 to 12 moth toddlers. Methodology: Subjects: 340 toddlers coming from Paediatric Serves of Sant Joan Hospital. Methods: At 6 and 12 months it done clinical history, food registry, biochemist determinations: haemoglobin, iron, transferrin, ferritin, reactive C protein and immune response (IL4, IL10, IL6 IFN, IgA, IgM, IgG, IgE). Mutations in the HFE gene: C282Y, H63D, S65D and hepcidin gene. Mental, psychomotor and behavioual development (Bayley Scales of Infant Development 2on Edition: 1993). We evaluate the level of language and communication (MacArthur), regulation and sensory process (Infant Toddler Symptom Checklist), familiar and environment surroundings (Scale Health General Parental Stress Index).

The aim of this study is to develop an adapted version of a low-cost parenting program (Parenting for Lifelong Health for Young Children, PLH) to the specific needs of families in three low- and middle income countries (LMICs) in southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova). The investigators want systematically evaluate key barriers and facilitators at the local, national and international levels that impact prevention of child behavioral disorders. The investigators will prepare training materials adapted to Romanian, Moldovian, Albanian, Macedonian, and Russian and train facilitators and mentor coaches in the delivery of the PLH program in each country. Also, a pre-post study will be conducted testing the feasibility of the program and the evaluation and implementation methods with 40 families at each country site. This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness on reducing child behavior problems and associated risk factors. This feasibility study is part of a larger implementation project. Developed on the MOST framework (the multiphase optimization strategy), this specific study will reflect the implementation of the first phase. There are two more phases to come: the Parenting for Lifelong Health for Young Children program will be optimized within the three countries by determining which components are most efficacious and cost-effective (phase 2). The optimized PLH programs will be tested in three RCTS in the countries (phase 3).