Clinical Research Directory

Development, Sensory Profile, and Sleep Quality in Preschool Children Across Different Caregiving Models

This observational study aims to examine developmental status, sensory processing, and sleep quality in preschool children aged 3 to 6 years across different caregiving models. Children raised primarily by first-degree relatives, second-degree relatives, caregivers, or in daycare settings will be compared. Data will be collected using the Denver II Developmental Screening Test, the Dunn Sensory Profile, and the Tayside Children's Sleep Questionnaire. The study will also evaluate the relationships among developmental status, sensory processing, and sleep quality, and explore whether caregiving model is associated with differences in these outcomes.

Enhancing Preschool Children's Attention and Behaviour: Parent-Focused Program

This study aims to evaluate the feasibility and efficacy of the Building Regulation in Dual Generations (BRIDGE) program for caregivers with significant mental health concerns and preschool and young children (3-7 years old) with elevated attention and/or behavior problems. The BRIDGE program focuses on supporting parental psychological distress and improving young children's self-regulation (SR), thereby reducing their attention and behavior problems. The long-term goal of this work is to improve family well-being and social-emotional development for young children by implementing an accessible and scalable dual-regulation program. The investigators will achieve this through the following key objectives: 1. Assess the feasibility and accessibility of BRIDGE for preschool and young children (3-7 years old) with significant attention and behavior programs through questionnaires asking about attendance, satisfaction, and unmet needs. 2. Examine the efficacy of BRIDGE compared to control group at improving maternal mental health and child attention and behavioral difficulties in young children (primary outcomes). The investigators will also examine parenting stress (secondary outcome). 3. Identify predictors of academic readiness skills in preschool and young children. The investigators hypothesize that an increase in parental and child emotion-regulation skills and reduced attention, as well as behavioral problems, will lead to increased pre-academic skills in children.

JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China

The growing recognition of maternal health's impact on offspring necessitates large-scale prospective cohort studies spanning the maternal-child life cycle. This study establishes a family-centered birth cohort of 100,000 Chinese participants, tracking from preconception through offspring adolescence to investigate early-life health trajectories and intergenerational transmission of diseases, health status, and psychological-behavioral patterns. Data collection includes biospecimens (placenta, cord blood, breast milk, blood, urine, feces) and multi-omics analysis (genomic, proteomic, metabolomic, microbiomic), alongside clinical information from preconception, pregnancy, birth through childhood (0-14 years). The cohort covers 24 stratified sites across China, incorporating real-time environmental monitoring (air pollution, meteorological data) and sociogeographic factors. Targeting reproductive-age couples (18-45 years) and their offspring, the study addresses multigenerational health linkages, urban-rural disparities, and regional diversity from 2025 to 2039. By integrating genetic, environmental and lifestyle data, this research will identify critical intervention windows and mechanisms for chronic disease transmission across generations, supporting China's "Healthy China" initiative and developing targeted strategies for population health and aging.

A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development

The aim of this study is to conduct a hybrid effectiveness/implementation assessment of the International Guide for Monitoring Child Development (GMCD) in two LMIC settings, India and Guatemala, within established rural CHW programs. The primary objectives are (a) to evaluate the real-world effectiveness of the GMCD; (b) to use an implementation science framework to understand barriers and facilitators to effective population coverage, provider implementation, and maintenance; (c) to conduct an economic evaluation of the GMCD.

Improving Cognition and Gestational Duration With Targeted Nutrition

The goal of this clinical trial is to test (1) a novel maternal ready-to-use supplementary food and (2) a novel cognitive behavioral therapy intervention in undernourished Sierra Leonean women. The main questions it aims to answer are: * Will the addition of omega-3 long-chain polyunsaturated fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), as well as choline, to a maternal ready-to-use supplementary food (M-RUSF+) prolong gestation when compared with a similar supplementary food except that it lacks DHA, EPA, and choline (M-RUSF)? * Will M-RUSF+ improve infant cognitive development at 9 months of age when compared with M-RUSF? * Will the novel CBT program improve ante- and post-partum depression?

Understanding Early Development of Infants and Toddlers

The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive functioning during the first years of life. The study will include infants and young children from 16 days of age up to 42 months of age, assessed during a single diagnostic session conducted by qualified specialists. The developmental assessment will include standardized diagnostic tasks and direct observation of behavior in the form of play and natural interaction, carried out in the presence of a parent or legal guardian. In addition, information regarding the child's everyday functioning will be collected from parents or caregivers using standardized questionnaires, including data on social-emotional competencies, communication, and adaptive skills. The main research questions addressed by this study are: What is the developmental profile of infants and young children in the first years of life? What relationships exist between different domains of early development within a biopsychosocial model of child functioning? Can specific developmental patterns be identified that indicate an increased risk of developmental difficulties in early childhood? How does age differentiate the structure and variability of developmental functioning across assessed domains? The study is non-invasive and observational in nature. Data will be analyzed exclusively in aggregated form and will contribute to a better understanding of early child development as well as to the development of norms and tools supporting early diagnosis and developmental intervention.

Psychological Correlates of Developmental Delays in Preschool Children

The goal of this observational study is to investigate perinatal, cognitive, linguistic and social-emotional correlates of developmental delays of preschool children. The study group consist of minimal 500 children between 3 and 6 years of age who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: cognitive functioning, linguistic skills and social-emotional functioning. Furthermore informations regarding social-emotional functioning of children, will be collected from parents. The main questions it aims to answer are: 1. Is there a relationship between perinatal factors and risk of occurrence of developmental delay disorder? 2. Is there a specific pattern of cognitive functioning in preschool children with indicated developmental delay disorder? 3. Is there a specific pattern of social-emotional functioning in preschool children with indicated developmental delay disorder? 4. Do gender and age moderates specific patterns of cognitive and socialemotional functioning in the studied groups? Researchers will compare the following groups of children between 3 and 6 years old: 1. With perinatal risks factors 2. With developmental delay disorder: 1. children with early intervention 2. children with delayed speech development 3. Control group

In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics

This study examines how maternal stress during pregnancy affects infant brain and behavioral development, focusing on whether these effects are due to the prenatal environment or shared genes. By comparing IVF pregnancies using donor eggs/embryos (no shared genetics) with non-donor IVF pregnancies, the investigators aim to understand how stress influences the baby's development independent of genetic factors. Participants will complete questionnaires, provide blood samples, and take part in placenta and cord blood collection, fetal monitoring, and newborn brain activity assessments. Aim 1: The influence of maternal distress on perinatal neurobehavioral development. Hypotheses: Independent of IVF group status, higher maternal AL will be associated with higher 3rd trimester FHR reactivity, lower FHR variability, AND lower FHR-movement coupling Aim 2: Maternal distress affecting placenta gene methylation. Hypotheses: Independent of IVF group status, maternal AL will be associated with placenta differential DNA methylation in glucocorticoid-regulating genes (FKBP5 and HSD11B2), Aim 3: Maternal experiences associated with unique placenta transcriptomic profiles. Hypotheses: Independent of IVF group status, maternal AL and well-being each will be associated with unique placenta gene expression in pro-inflammatory genes

Prospective Cohort Study of Protected Children

A significant number of children are abused or neglected every year. This exposure is associated with short- and long-term consequences for their mental and somatic health. In France, 308,000 minors are benefiting from at least one child protective service or measure. There are few data on the health status of this population, and how it is evolving. Against this backdrop, interventions are needed to address the many needs of these children early and comprehensively, both in the short and long term. The PEGASE program, funded by the French government under Article 51, aims to ensure adequate medical follow-up - both somatic and psychiatric - for children taken into care by child protective services (CPS). An evaluation of the program's effectiveness and efficiency is needed to inform public decision-making on the appropriateness of extending it to all children under CPS's care. This requires the creation of a control cohort of children followed by CPS but not benefiting from the PEGASE program, the ESPER cohort (Prospective cohort study of protected children), which will enable us to carry out a comparative evaluation of the PEGASE program, as well as to provide information on the health of children followed by the CPS at the time of their placement and its evolution over time, data which are rare in France. The main objective is to evaluate the effectiveness of the PEGASE program on the evolution of the mental health of children followed by the CPS after 2 years of follow-up.

Integrating Systems and Basic Income: Improving Outcomes for Families of Young Children

Early childhood is a critical period, laying the foundation for future growth and deveopment. This foundational period has an outsized effect, impacting health, well-being and achievement across one's lifespan. The U.S. lacks a cohesive early childhood system to support families with young children ages 0-5. The goal of this randomized controlled trial(RCT) is to test if community-based support via community health workers(CHWs) improves social and health services utilization, and child development. Furthermore, the trial will examine if income support enhances the impact of a CHW integrated system. Participants are English and Spanish speaking families with healthy newborns. This RCT was designed based on family priorities, community capacity and needs in a collective impact model. This trial is anchored at a university based children's hospital and involves many partners: families, county health, county leadership, a leading early childhood non-profit organization, the county's Medicaid managed care organization.

Catholic Health Initiatives (CHI) St. Joseph's Children Home Visiting Longitudinal Study

This study involves a long-term outcome study of the Catholic Health Initiative St. Joseph's Children (CHI SJC) program using a randomized control study. The purpose of this study is to determine the short-term and long-term impact and effectiveness of the CHI SJC program. The CHI SJC program has not been studied to determine program effectiveness. The investigators intend to follow families and their children until the children in the study graduate from high-school or turn 19 years of age. The study, as a template, uses the eight outcome domains listed and described in the Home Visiting Evidence of Effectiveness website (http://homvee.acf.hhs.gov/outcomes.aspx). These eight domains are: * Child development and school readiness * Family economic self-sufficiency * Maternal health * Reductions in child maltreatment * Child health * Linkages and referrals * Positive parenting practices * Reductions in juvenile delinquency, family violence, and crime The investigators expect to observe significant differences among the two groups with respect to the primary outcome domains listed. The investigators expect study group members randomized to the CHI SJC program will perform better on the eight outcome domains. Other hypotheses include: Other Hypotheses: Hypothesis 1. Randomization to CHI SJC will be associated with higher quality functioning and better child health and well-being. Hypothesis 2. Randomization to CHI SJC will result in more connections to community resources. Hypothesis 3. Randomization to CHI SJC will result in improved indications of maternal health and positive parenting practices. Hypothesis 4. Randomization to CHI SJC will be associated with higher measures of family economic self-sufficiency. Hypothesis 5. Randomization to CHI SJC will be associated with increased school readiness and school progress and attainment. Hypothesis 6. Randomization to CHI SJC will be associated with reductions in juvenile delinquency, family violence, and crime. The study will collect outcome data in the same way and, at the same time, from treatment and control group members. Data collection will primarily be comprised of a set of self-report questionnaires and a review of administrative records that target the outcome domains described earlier. Study group members will be assessed at baseline, 6 months, 12 months, 18 months, 24 months, 3 years, 5 years, 8 years, 12 years, 15 years, and at high-school graduation or 19 years of age.

Impact of Diet and Nutrition on Growth and Development in Young Children

The association between nutrition in early life and its long-term health consequences has long been known. However, there is a scarcity of scientific evidence on how nutritional status affects child growth and development in remote, rural agro-pastoral communities with distinct dietary intake habits, geographical location, socio-economic status, and cultures.

Motor-Focused Exercise and Brain Development in Preschool Children

This study will test whether a structured motor-focused exercise program can improve both brain function and gross motor skills in preschool children. About 110 children aged 4 to 6 years will be recruited from kindergartens in Changsha, China. Classes will be randomly assigned to receive either (1) motor-focused physical education three times per week for 16 weeks, or (2) ordinary physical education of the same frequency and duration. The motor-focused program includes playful, game-based activities designed to strengthen locomotor skills (such as running and hopping) and object-control skills (such as throwing and catching). The main outcome will be changes in children's gross motor skills, measured with a standardized motor test (TGMD-3). Brain activity will also be assessed using portable electroencephalography (EEG) during rest and simple tasks related to attention and memory. Parents and teachers will complete short questionnaires about children's behavior and executive function. The results of this study may provide new insights into how physical education influences both movement skills and brain development in early childhood.

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.

China Axial Length Study

The primary objective of this multi-center, observational study is to establish the reference ranges of axial length in Chinese children and adolescents. 30,000 children aged 3-18 years were examined with cycloplegia to collect their ocular parameters and were all followed up for three years with annual visits.

Study Protocol: Cognitive, Emotional and Social Stimulation Programme for Low-SES Children.

Latin America and the Caribbean exhibit high rates of poverty and social exclusion, where a significant portion of the population faces challenges in meeting basic needs. This socioeconomic vulnerability exacerbates environmental violence and its associated consequences. Recognizing that contexts of poverty and social exclusion can adversely impact children's cognitive and emotional development, this research protocol aims to address these challenges. It proposes a cognitive and emotional stimulation program, complemented by an intervention targeting teachers and caregivers, grounded in neuroeducational principles. The overarching goal is to enhance children's cognitive and academic performance, thereby improving their long-term quality of life. Methods: A randomised controlled trial will be conducted to evaluate the efficacy of the intervention in an experimental group compared to a control group. A sample of more than 500 children from primary schools in disadvantaged contexts in Colombia A digital stimulation programme, designed and supervised by neuropsychologists, will be implemented within the classrooms and will be complemented with educational sessions in neuroeducation for teachers and caregivers, with weekly activities for 3 months. Three evaluations will be carried out: 1) pre-intervention, 2) post-intervention and 3) follow-up. During follow-up, the control group will receive the stimulation programme. Conclusions: The researchers anticipate a positive impact on the cognitive, emotional and academic performance of these children, providing evidence and support for the long-term creation of a tested and validated cognitive and emotional stimulation programme that could be integrated into the academic curriculum of educational centres in disadvantaged contexts.

A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers

The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)? * Is the intervention feasible for parents to implement, as measured by a parent feedback survey? Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence. Parents and Participants: * Children will wear an accelerometer to track physical activity and sleep patterns. * Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children. * Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks. * Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.

The Pittsburgh Study Early Childhood

The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families.

CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development. There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes).

Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)

More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 142 school-aged children (6-12 years) who have a BMI above average, defined as age- and sex-specific BMI Z-score above zero using WHO reference standards, and habitually sleep for ≤ 9 h/night. Data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). The collection of data is mainly related to the main study. However, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-I (metabolic mechanisms, n=60) and substudy-II (learning mechanisms, n=142). The primary objective is to assess the effects of sleep extension by \~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who have a BMI for age and sex above average, and sleep less than recommended for their age.

Embodied Writing Versus Conventional Writing Practice for Handwriting

This randomized clinical trial will involve 148 preschooler children of age group 3 to 6 years old with handwriting difficulties from Cambridge Foundation School FSD and Behan Je Memorial school FSD, Pakistan. The participants will be divided into two groups: Group A will follow conventional writing practices with parental ergonomics guidance, while Group B will engage in embodied writing practices combined with ergonomic education for parents. Over 8 weeks, handwriting legibility, speed, and motor coordination will be assessed pre- and post-intervention using the Handwriting Proficiency Screening Questionnaire and the Minnesota Handwriting Assessment Scale. The study aims to evaluate each approach's effectiveness in addressing handwriting challenges, providing insights into embodied learning's potential impact on early childhood education. Data analysis will be conducted using SPSS version 23.

Effects of Animal Fun Program in Children With DCD.

This randomized clinical trial investigates the effects of animal fun program on motor skills in children with developmental coordination disorder. The study involves 40 children from normal school age group 6 to 12 year old, who will be randomly assigned to one of the two groups for a six-week intervention period. Key performance outcomes -body management truck control, locomotion, balance ,object control,body sequencing social and emotional control will be assessed both before and after the intervention.This study aims to address this gap by evaluating the effects of the Animal Fun Program on both fine and gross motor activity levels in children diagnosed with DCD. By examining objective motor outcomes and child engagement, the study seeks to determine whether this novel, enjoyable intervention can enhance traditional therapy methods, leading to improved motor development and overall quality of life for children with DCD. Data will be analyzed through SPSS version 27.00.

Peking University Birth Cohort in Weifang (PKUBC-WF)

The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.

Testing of Online Version of QAPS

Early evaluation of prewriting skills is important, as prewriting skills set the stage for later learning of the fine motor and visual motor skills needed for writing. Evaluation of prewriting skills allows for the identification of those children who struggle with these tasks so that early intervention might address these foundational skills before academic demands become more challenging. However, current prewriting skill assessments are limited to pencil-and-paper assessments that require an evaluator to score the drawn shapes. Manual scoring is time consuming, can be subjective, and limit the ability to capture subtle changes in performance. We have developed an assessment on a tablet to assess prewriting skills in children. The preliminary testing of the assessment is published in a paper (https://pubmed.ncbi.nlm.nih.gov/35417278/). We are now working on developing an online version of the assessment that will allow offsite data collection and will automate the analysis on the website so that the results can be automatically generated for the clinician or educator who wants to use this with the children they work with.