Active clinical trials for "Neurodevelopmental Disorders"

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.

This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.

The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of our implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention, and active coaching for up to 12 sessions as dictated by the intervention procedures. The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self- advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities). For Remaking Recess, school personnel will be working with children with ASD using the Remaking Recess Intervention (play-based intervention done during recess). School personnel will be trained to implement the intervention. The total time commitment for the school personnel is about 30 hours. The total time commitment for the parents with ASD who will sign consents and fill out a demographic survey is about 15 minutes. The total time commitment for children with ASD or other neurodevelopmental disorders (NDD) is about 5 hours during their regularly scheduled recess period throughout the school year.

Children with special education needs (SEN) (e.g., autism, attention-deficit/hyperactivity disorder, dyslexia) who are studying in the mainstream primary schools are commonly found to have difficulties in learning school materials, and controlling their emotion and behaviors in class. Such schooling problems are likely related to their deficient attention, self-control ability and language abilities. As a result, they will easily be stressful, losing confidence, or even be the target of bullying or discrimination. This project aims to evaluate a neuroscience based after-school training program, namely EC Brain Program, to improve academic performance, cognition (attention, self-control and language ability), behaviors and psychological health of primary school students with SEN. The EC Brain Program is composed of computerized training programs that were developed to enhance abilities of attention, self-control and temporal processing (i.e., a fundamental cognitive ability in mastering reading and language skills), and education on basic neuroscience knowledge and ways to enhance brain functions and psychological wellness, e.g., relaxation, stress management and balanced healthy diet. A total of 100 - 250 students with SEN from 10 ordinary primary schools will be recruited in 3-year period. They will be randomly assigned into two groups. Both groups will undergo pre- and post-assessments evaluating their academic performance, cognitive functions, saccadic eye movements, physical and mental health conditions before and after the training. Students in the group A will have to participate in the EC Brain after-school program, whereas students in the group B will join conventional intervention. It is an eight-month weekly program, 90 minutes per session. It is hypothesized that students who have joined the EC Brain Program will show greater extent of improvement in academic performance, behavioral problems, cognitive functions (e.g., attention, learning, self-control, language), saccadic eye movements and psychological wellness than those in the other group. The findings of present study will shed some light on the effectiveness and applicability of the EC Brain Program as a potential after-school neuropsychological intervention for students with SEN.

Double blind, placebo-controlled, randomised trial, multicentre in France with open-label tolerability phase. The double-blind placebo-controlled study duration will be scheduled for 3 months with the final visit of the double-blind period at D84. After the D84 assessment, patients will be invited to continue into a 6-month openlabel study extension (OLSE) with ex-Sialanar® patients continuing the treatment and ex-placebo patients starting Sialanar®

Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design. Pregnant women will be approached during one of their fetal cardiology clinic visits.

This randomized control trial aims to investigate whether a novel intervention, the "Building Regulation in Dual Generations (BRIDGE)" program, improves mental wellness and parenting practices among mothers of 3 to 5-year-old children who have elevated symptoms of depression. The main two questions this study aims to answer are: Does participation in the BRIDGE program reduce maternal depression symptoms? Does participation in the BRIDGE program improve children's mental health? Researchers will compare the BRIDGE intervention to an established mental health intervention (i.e., Dialectical Behaviour Therapy skills group) and to a services-as-usual control group to see if participation in BRIDGE leads to greater improvements than either the general mental health treatment or community services as usual. Participants will: Complete a set of questionnaires pre- and post-intervention, and at 6-month follow-up. Complete a virtual assessment with their child at pre- and post-intervention. Be randomized to BRIDGE, Dialectical Behavioural Therapy(DBT) skills group, or a services-as-usual control group. Participate in the 16-week BRIDGE or DBT Skills only group, if randomized to either of these groups. If they are randomized to services-as-usual they will receive a list of community resources they can access. Complete weekly symptom monitoring via questionnaires, if randomized to BRIDGE or DBT Skills Wear a Fitbit device during pre- and post-intervention, as well as throughout the 16-week intervention period.

The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of an implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention, and active coaching for up to 12 sessions as dictated by the intervention procedures during a time span of 6 months. The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self-advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities). For MTG, peer navigators (staff working in an organization that already works with parents) and parents (with children with ASD) will meet via phone or video conference for up to 12 sessions within a 6 month span (an hour each time). They will go over sessions that were created by the research group that help parents understand the system of acquiring services. The total time commitment for peer navigators is about 18 hours and for parents with children with ASD is about 8.5 hours. Identified families connected to the community organization will be matched with one peer navigator who will then guide and support the caregiver through completion of the MTG modules with active coaching of the family. Family needs and preferences will guide topic selection. Active coaching will occur via zoom, or over the phone, based on family preference and some recorded sessions will be shared with the research group for analyses. Mind the Gap will be available in English, Spanish, and Korean.

This project aims to: explore the effectiveness of Neurofeedback therapy for children diagnosed with Autism Spectrum Disorder (ASD) assess if cognitive functions are affected before and after Neurofeedback Intervention

Feasibility RCT to ask: Can the investigators coproduce, with parent collaborators, a new service, Infant Parent Support (IPS), to improve the mental health of children with a social worker? Can the investigators test the feasibility of an RCT of IPS compared with services as usual?