Intellectual Disability

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 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.

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 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.

Researchers are evaluating a new tablet game-based tool designed to assess neurodevelopment in young children aged 3 to 8 years. This study aims to determine if the game can accurately distinguish between typically developing children and those with neurodevelopmental disorders such as ADHD, Autism Spectrum Disorder, Specific Learning Disorder, or Communication Disorder. It also seeks to assess how valid and reliable the game-based assessment is for evaluating a child's neuropsychological functions. Participants will complete the tablet game-based assessment, which evaluates attention, memory, language, motor skills, executive functions, and social-emotional abilities. Parents or caregivers will fill out a demographic questionnaire and the Adaptive Behavior Assessment System, Third Edition (ABAS-3), to provide additional developmental information. Some children may be asked to repeat the game assessment about two weeks later to check the consistency and validity of the tool. Children's involvement includes playing the game-based assessment and having their caregivers complete questionnaires about their development and background. The study will measure diagnostic accuracy, validity, internal consistency, predictive validity, and safety of the assessment over a period of 16 months. Researchers will also collect preliminary normative data, evaluate the acceptability of the tool, and assess test-retest reliability to ensure the assessment's usefulness and safety throughout the study.

Researchers are studying adolescents and young adults with autism spectrum disorder (ASD), a condition marked by difficulties in communication, social skills, and repetitive behaviors. The study aims to understand how a brain stimulation technique called transcranial direct current stimulation (tDCS) might reduce symptoms like anxiety and impulsivity. The research also seeks to use brain activity data and clinical information to predict who will respond well to this treatment. Participants will receive active tDCS for 10 sessions over two weeks, one session per day on working days. During each 20-minute session, they will perform exercises designed to improve processing speed and executive function while receiving brain stimulation. After treatment, participants will be classified as responders or non-responders based on improvements in social responsiveness scores. Throughout the study, participants will undergo various assessments including behavioral scales, cognitive tests, and neurophysiological measurements at the start and after the treatment period. Researchers will track changes in social communication, repetitive behaviors, and brain function. This will help determine the effects of tDCS and identify characteristics that predict treatment response, with the total study duration extending up to the final follow-up in 2026.

This research aims to evaluate the feasibility of a parent-child yoga intervention designed to reduce attention deficits in children aged 4 to 6 years with congenital heart disease (CHD). Children with CHD often face neurodevelopmental challenges, including a higher risk of attention deficit hyperactivity disorder (ADHD). This study is a preliminary step before conducting a larger randomized controlled trial (RCT) to test the effectiveness of this intervention in improving attention and long-term academic and psychosocial outcomes for these children and their families. The study is a single-blind, two-center, two-arm randomized feasibility trial involving 24 parent-child pairs. Participants will be randomly assigned in a 2:1 ratio to either an 8-week parent-child yoga program plus standard clinical care or standard clinical care alone with a waitlist option for yoga after the study. The yoga sessions last 45 minutes each week and include active and calming parts embedded in stories suitable for the child's developmental level. Parents and children will also be encouraged to practice 5-minute at-home exercises three times a week throughout the 8-week period and continue up to a 6-month follow-up. Participants will undergo three neurodevelopmental assessments: before the intervention, immediately after, and six months later. The study will monitor recruitment, dropout, and adherence rates; acceptability of randomization; variation in yoga delivery; and data completeness. These measurements will help determine the feasibility of the procedures and inform the sample size for the future full-scale RCT. Overall participation spans about eight months including the intervention and follow-up periods.

Researchers are studying a birth cohort of infants to understand how allergies might be linked to neurodevelopmental disorders such as autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), and learning disabilities. The study aims to identify factors in early life that influence these neurodevelopmental outcomes using standard diagnostic criteria (DSM-5). This observational study is led by Qilu Hospital of Shandong University and focuses on children living in Jinan City and nearby areas in China. Infants in the study are divided into two groups based on allergy status: an allergic group and a control group without allergies. They will be followed for up to six years, with periodic collection of biological samples like blood, urine, and feces. Growth measurements such as height and weight, along with developmental assessments like the GESELL test, will be recorded during regular follow-ups. Participants will undergo evaluations to monitor for signs of ASD, ADHD, or learning disabilities over the study period. Researchers will gather data through questionnaires and clinical examinations at multiple time points from 2023 to 2029. This long-term follow-up helps assess how early-life allergies may affect neurodevelopment. The study provides ongoing monitoring but does not involve any treatment interventions.