Autism Spectrum Disorder (ASD)

Researchers are evaluating an early behavioral intervention program for toddlers aged 16 to 48 months who are waiting to receive a formal autism diagnosis. The study aims to address delays in autism diagnosis and intervention by offering caregivers access to a self-directed online training resource during the waitlist period. This approach seeks to empower parents to support their children's development early, potentially reducing the harms associated with waiting for diagnosis and intervention services. Participants will be randomly assigned to either receive access to the "Online Parent Training in Early Behavioral Intervention" (OPT-In-Early) program or be placed on a waitlist without intervention for six months. The OPT-In-Early program includes 14 modules (6 mandatory and 8 optional) with text and video materials teaching caregivers strategies to improve language, social, and adaptive skills and reduce disruptive behaviors. Parents can also schedule brief support calls with a clinician for guidance during the intervention period. After six months, waitlist participants will gain access to the program, but outcomes will not be measured for them. Throughout the study, caregivers complete assessments including individualized goal setting with video recordings to capture their child's current skills and progress. Standardized measures of adaptive behavior, parental stress, and autism-related challenges are collected at baseline and after six months. Researchers will monitor program engagement using website usage data and support call frequency. The primary outcome is change in goal attainment as measured by Goal Attainment Scaling, with additional measures assessing adaptive functioning and parental well-being. The total participation time is six months, during which families receive ongoing support and data collection.

Preterm birth, defined as birth before 37 weeks of gestation, occurs in about 8 percent of pregnancies in Canada and is linked to many health challenges, especially when it happens before 29 weeks. At this early stage, infants often face breathing difficulties and may require resuscitation. This trial compares resuscitation using either low (30%) or high (60%) oxygen levels to determine which approach results in better survival and neurodevelopmental outcomes at around 24 months of age. The study uses a cluster randomized crossover design where hospitals alternate between starting resuscitation with 30% or 60% oxygen for groups of 30 infants. Resuscitation includes standard care steps like lung expansion and ventilation support as needed. Oxygen is initially given at the assigned concentration for the first 5 minutes, then adjusted based on the infant's oxygen saturation levels and heart rate over the next 5 minutes to maintain target saturation ranges. This approach aims to balance risks of too much or too little oxygen. Participants are infants born between 23 and 28 weeks gestation who receive full resuscitation at participating centers. During the study, infants have oxygen saturation monitored continuously, and adjustments to oxygen concentration are made carefully. Researchers will evaluate survival and major neurodevelopmental outcomes at 24 months corrected age, along with several safety and health measures during the neonatal intensive care stay. The trial is expected to provide important evidence to guide oxygen use during resuscitation of extremely preterm infants.

Researchers are evaluating a 12-week early intervention program designed to address social communication difficulties in young children with developmental disorders. The program targets children diagnosed with conditions such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability. The goal is to assess how well this program supports social skills in preschool-aged children. The intervention involves 12 hours per week of intensive treatment delivered either in a center-based preschool setting or at home. Over the 12-week period, children receive structured support tailored to their social communication needs. This program is being studied as a behavioral approach to improve developmental outcomes. Participants will be assessed before and after the 12-week program using parent-rated questionnaires that measure social responsiveness, repetitive behaviors, social dimensions, adaptive behavior, sensory profiles, and self-efficacy. These evaluations help researchers monitor changes in social communication and related behaviors. The total participation duration in the study is 12 weeks, with assessments at the start and end of the program.

Researchers are evaluating a Chatbot-based program designed to promote well-being in caregivers of children with Autism Spectrum Disorder (ASD). ASD involves challenges in social communication, cognitive development, behavior patterns, and sensory processing. Caring for children with ASD can be stressful and impact parents' mental health, which in turn affects the success of early interventions for their children. This study aims to improve caregivers' well-being, reduce stress and depressive symptoms, and enhance quality of life through this innovative digital approach. The study involves a randomized controlled trial where 130 caregivers of children aged 6 to 11 years with ASD will be assigned to either the Chatbot intervention group or a control group receiving one-page information about ASD. The Chatbot uses conversational AI with modules focusing on positive psychology exercises, useful information on healthcare and community resources, and peer networks for sharing experiences. The intervention is designed to be accessible, personalized, and available at any time to support caregivers. Participants will be assessed at baseline, 3 months, and 6 months for well-being, depressive symptoms, quality of life, parenting stress, and the feasibility of using the Chatbot. Caregivers will communicate with the Chatbot as part of the intervention, while control participants receive only informational material. The study will monitor outcomes over the six-month period to evaluate the program's impact on mental health and caregiving experiences.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are investigating the effects of the PAX Good Behavior Game (GBG) in Swedish primary schools to address growing concerns of mental health issues among children and stress-related symptoms in teachers. This cluster-randomized controlled trial involves 28 schools and about 84 teachers, aiming to improve student well-being and reduce teacher stress. The study compares PAX GBG to active control interventions that also provide teacher training but with different content. The trial includes extensive measurements over two years, including self-assessments, classroom observations, sound level monitoring, sick leave data, and qualitative interviews. Teachers randomized to the PAX GBG group receive a two-day training on ten specific tools designed to promote prosocial and focused behaviors in classrooms, including a team-based game rewarding good behavior. Control schools choose between two alternatives: 'Count On Me!', a math fluency application for pupils, or a Collegial Learning Community intervention focused on professional development for teachers. Both groups receive similar amounts of training and supervision, including multiple sessions during the school year. The interventions are integrated into regular classroom activities starting in grade 1 through grade 3. Participants include approximately 2200 pupils and their teachers, with data collected through various methods such as questionnaires, standardized tests, observer ratings, and registry data. Measurements occur at multiple time points over two years, focusing on pupil well-being, teacher stress, classroom behavior, noise levels, and implementation fidelity. The study also evaluates cost-effectiveness by comparing health outcomes and related expenses. Safety and adverse events are monitored through teacher reports and interviews, ensuring comprehensive assessment of the interventions' impact.

Researchers are comparing two school-based programs, Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR), to see which is more effective at reducing anxiety and improving emotion regulation in autistic students aged 8 to 14 years. This study focuses on autistic youth who experience anxiety and aims to help schools better support their mental health, especially students from underserved communities. The trial will also assess how well each program is accepted by students, caregivers, and school providers. The study involves 200 autistic students with anxiety who will be randomly assigned to one of the two programs for 12 weeks. FYF-SB uses cognitive-behavioral therapy (CBT) strategies focused on anxiety reduction through psychoeducation and gradual exposure to fears. ZOR teaches students to recognize and manage emotions by categorizing feelings into four "zones" using color codes and providing strategies to regulate emotions. Trained school providers will deliver the programs to small groups of students in their schools. Participants will be evaluated before and after the intervention, with a follow-up six months later. Assessments include anxiety and emotion regulation measures completed by students, caregivers, teachers, and independent evaluators. The study will also track school attendance, disciplinary actions, academic participation, and satisfaction with the programs. Researchers will examine treatment effects and gather feedback through surveys and interviews to understand how feasible and acceptable each program is in school settings.

Adults with intellectual disabilities often face challenges in social situations due to difficulties in processing social information, especially in recognizing facial emotions. This research evaluates a cognitive remediation program called Re9habilitus, designed to improve attentional and visuospatial functions to reduce behavioral disorders in adults with intellectual disabilities who do not have autism spectrum disorder. The study aims to validate whether this program can help address specific cognitive and behavioral issues in daily life for this population. Participants are randomly assigned to either the Re9habilitus cognitive remediation program, which focuses on improving attention and spatial perception related to social behavior, or to a control group engaging in manual activities and computer-based research tasks. The study compares these two approaches to assess their effects on behavioral disorders and cognitive functions. During the study, participants are assessed on changes in hyperactivity and non-compliance behaviors using the Aberrant Behavior Checklist scale over six months. Researchers also measure improvements in facial emotion recognition and attentional functions at the start, end, and six months after the intervention. The total participation time and safety monitoring details are aligned with the evaluation periods, ensuring thorough follow-up to observe lasting effects.

Researchers are evaluating a self-directed, online parent-training program designed to help young children with autism spectrum disorder or social communication delays develop important skills during a critical period of brain development. This pilot randomized controlled trial will compare the effects of this digital intervention to treatment as usual, aiming to support families facing challenges like diagnosis delays, long waitlists, and limited access to services. The study also explores how willing parents are to engage with the program to improve their children's communication and daily living abilities. The study includes two groups: one will continue their usual care, and the other will use the OPT-In-Early program, which consists of 14 online modules featuring text, narration, and videos that teach parents naturalistic developmental behavioral intervention strategies. These strategies focus on increasing children's social engagement, communication, adaptive behaviors, and reducing challenging behaviors. Families in the usual care group will get access to the program after completing the study. Participants will be assessed at the start and after four months using measures such as the Motor Imitation Scale, Vineland Scales of Adaptive Behavior-3, and the MacArthur-Bates Communicative Development Inventories. Additional assessments include goal attainment, quizzes on the program content, and treatment evaluations. Parents must complete two study visits and have internet access to participate. The total study duration for each child and parent is four months, during which researchers will monitor progress and parent engagement.

Researchers are studying disability risk in older adults to identify key factors that lead to disability and to develop a precise, digital system for early warning and prevention. This study integrates multiple data sources, including health records and cognitive assessments, to build a risk stratification model and an intelligent early warning system. The goal is to create a collaborative hospital-community-household system that actively manages disability risk in diverse urban and rural settings. The study involves implementing a digital platform that provides comprehensive assessments, dynamic monitoring, and targeted interventions for disability risk in older adults. Participants are randomly assigned to either an experimental group receiving these digital interventions or a control group receiving routine community-based health management like health education, exercise guidance, and dietary counseling. Participants will be involved for at least six months, with assessments at the start, three months, and six months after intervention. These include physical performance tests, disability risk scoring, and monitoring of intervention adherence. The study measures outcomes such as physical function, incidence of disability, and compliance with interventions to evaluate the effectiveness of the digital system in managing disability risk.