Clinical Research Directory

Impact of a Medical-Financial Partnership Intervention on Parent Mental Health, Perinatal Outcomes, and Child Developmental Risk

Poverty and financial stress are key social drivers of health and root causes of worse health beginning in pregnancy, continuing into childhood, and extending over the life course, but clinical tools to address the health impacts of poverty and financial stress are needed. This trial is of a multi-site medical-financial partnership intervention to examine its effect on parent, perinatal, and child outcomes, as well as health care utilization, and family financial and social risk. This pragmatic randomized clinical effectiveness trial will examine the impact of a clinic-based medical-financial partnership intervention beginning either 1) in the newborn period (Intervention Arm 1) or 2) during prenatal care (Intervention Arm 2) versus controls on parent, child, and family/household outcomes.

Embracing Morning BReakfast and Activity for Classroom Engagement

This experiment will test the effects of healthy breakfast and morning exercise on children's focus and classroom behavior. Food and exercise each influence child focus, but little is known about their effects on classroom behavior and less about their combined effects. For one week (Monday-Friday), 10 children will be randomly assigned to receive healthy breakfast and morning exercise, 10 assigned to only healthy breakfast, 10 to only exercise, and 10 to neither. After exercise and breakfast, study staff will assess how focused children are during class-time, ask them to complete puzzle-like tasks, and wear a helmet that measures brain blood flow

The Influence of Maternal Age, Employment Status, and Parenthood Status on Children's Cognitive Development

Research and theory tend to agree when suggesting that certain activities done by mothers have both immediate and delayed consequences for children's mental development in the first years of life. The everyday interaction between an infant and a caregiver can be broken down into many categories. There are data linking both of these types of interaction to the mental development of children. The study will focus on the extent to which maternal characteristics (age, employment status, parenthood status, and birth order of the child) influence the relation between maternal social and didactic caregiving and the social and mental development of children. Mother-infant interaction will be observed when the infants are 5 months old. When the children are 20 months old, measures of toddler function (e.g., ability to play and language development) and maternal behavior (e.g., encouragement of attention to the environment and I.Q.) will be obtained. When the children are 48 months old, researchers will measure preschooler psychosocial functioning (e.g., I.Q., cognitive and social competencies) and maternal behavior (e.g., "scaffolding"). Understanding the relation between children's experiences as infants, toddlers, and preschoolers and their eventual intellectual and social functioning is an essential part of normal developmental research.\<TAB\>

LOVING (Learning About Our Behavior is Valuable for Increasing Nurturing Relationships and Healthy Growth) RCT

The LOVING study is a randomized controlled trial designed to determine whether adaptations to an internationally recognized parenting program that enhances sensitive caregiving likewise improves sensitive caregiving in Singapore and, in turn, downstream child outcomes in emotional, behavioral, and cognitive development during the early childhood years. Research shows that sensitive caregiving is linked to secure relationships, decreased child mental health problems, better executive functioning, and potentially healthier body mass indices. The Video Feedback to Improve Positive Parenting and Sensitive Discipline (VIPP-SD) program is an internationally recognized home-based intervention designed to enhance sensitive caregiving. However, evidence demonstrating its efficacy in Asia remains extremely limited. Moreover, most previous evaluations have focused primarily on parenting or child mental health outcomes, with newer work only beginning to focus upon additional child outcomes. In this study, families with young children from median-income and below households living in Singapore will be randomly assigned to one of three groups. Some families will participate in a locally adapted version of the home-based VIPP-SD program that includes additional health-related scenarios (VIPP-SD-SingH). Other families will be assigned to CARE-SD, which was developed within the context of proof-of-concept research. CARE-SD is a standardized, digitally delivered parenting program using vicarious pre-rendered video examples and comments derived from the VIPP-SD program and does not include personalized feedback during home visits. Furthermore, CARE-SD includes health related scenarios and language and settings familiar to families living in Singapore. A third group will receive developmental information about children's learning and development (i.e., NeuroEducation Active Control). The programs are brief and are designed to be practical and accessible for families. Families participating in the study will take part in research visits that include questionnaires, observations of parent-child interaction, and activities designed to assess children's development. Laboratory visits will take place at IHDP (a collaborating institution) research facilities. Information collected in the study will help researchers better understand how parenting support programs influence children's emotional well-being, behavior, learning, and physical health. The results of this research may help inform the development of effective programs to support families and promote healthy child development.

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.

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 Monitoring of Children Born in Haute Vienne From Uterine Life to Adulthood

The purpose of this survey is to collect data from intrauterine life until the age of 18 of children born in Haute Vienne. The interest to realize such survey is to find correlations and interactions that may exist between the events that occurred during intrauterine life and those that will occur after the birth of the child. The investigators will examine every aspect of these children's lives from the perspectives of health, social sciences and environmental health These are medical events (occurrence of disease, medication), but also socio-cultural for this child (living environment, exposure to possible contaminants, events in family history). This cohort aims to include 3000 children a year (whose parents consented to their inclusion), all born at Haute-Vienne.

Interventions in Mathematics and Cognitive Skills

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

Sharing Tales That Teach: Shared Picturebook Reading for Early Childhood Emotional and Cognitive Development

Sharing Tales That Teach is a randomised study of a shared picturebook reading programme for 4- to 5-year-old children and their primary caregivers. The study will test whether a caregiver-delivered, emotion-focused shared reading programme leads to greater improvements in children's emotion regulation than a standard dialogic shared reading programme. Emotion regulation refers to children's developing ability to understand, express and manage emotions in ways that support learning, relationships and wellbeing. These skills are closely linked with executive function, including children's ability to remember instructions, control impulses and shift flexibly between activities. Shared picturebook reading may provide a natural, low-cost way for caregivers to support these skills through everyday interaction. Families in the randomised part of the study will be allocated to one of two 8-week shared reading programmes. In the emotion-focused group, caregivers will receive training in strategies such as naming emotions, discussing why characters feel as they do, talking about consequences of emotions and modelling ways to manage feelings. In the comparison group, caregivers will receive training in standard dialogic picturebook reading strategies, such as naming, describing, sequencing and asking open questions, without an explicit focus on emotions or emotion regulation. Both groups will use the same picturebooks and will be asked to complete three shared reading sessions per week at home. The main hypothesis is that children in the emotion-focused shared reading group will show greater improvement in emotion regulation from baseline to 12-month follow-up than children in the standard dialogic shared reading group. The study will also examine whether the programme affects children's executive function, caregiver wellbeing and caregiver emotion regulation. Additional exploratory analyses will examine caregiver-child interaction processes and whether caregiver or child characteristics are associated with different intervention effects. The study will recruit caregiver-child dyads through state primary schools in Greater London. Children will complete age-appropriate tasks and caregivers will complete questionnaires at baseline and follow-up. A laboratory subsample may also complete additional behavioural, observational and neurophysiological assessments. The study is low risk, non-invasive and does not involve medical treatment.

Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya

An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are a) still too expensive to implement at scale in low-resource and rural settings, and b) their early impacts tend to fade over time in the absence of continued support. New ways to deliver effective ECD parenting interventions are sorely needed that are both low-cost to be potentially scalable, while also able to sustain impacts long-term. The rapid growth and low cost of mobile communications in LMIC settings presents a potentially promising solution to the competing problems of scalability and sustainability. Yet there is no rigorous research on mobile-health (mHealth) interventions for ECD outcomes in LMIC settings. Study investigators recently showed that an 8-month ECD parenting intervention featuring fortnightly group meetings delivered by Community Health Workers (CHWs) from Kenya's rural health care system significantly improved child cognitive, language, and socioemotional development as well as parenting practices, and a group-based delivery model was more cost-effective than previous ECD interventions. Yet it is still too expensive for scaling in a rural LMIC setting such as rural Kenya, particularly if interventions are needed that can be extended for longer periods of time to increase their ability to sustain impacts. This study will experimentally test a traditional in-person group-based delivery model for an ECD parenting intervention against an mHealth-based delivery model that partially substitutes remote delivery for in-person group meetings. The relative effectiveness and costs of this hybrid-delivery model will be assessed against a purely in-person group model, and the interventions will extend over two years to increase their ability to sustain changes in child outcomes longer-term. The evaluation design is a clustered Randomized Control Trial across 90 CHWs and their associated villages and 1200 households. The central hypothesis is that a hybrid ECD intervention will be lower cost, but remote delivery may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program.

Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months.

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.

Mother-infant Bonding During COVID-19

This study will assess whether the promotion of emotional exchange between mother and infant during the first four months of life improves primarily mother-child early relational health (ERH) and secondarily child neurodevelopmental and maternal mental health outcomes. In prior research on preterm infants, a similar intervention demonstrated increased quality of maternal caregiving behaviors and significant improvements in premature infants' neurodevelopment across multiple domains, including social-relatedness and attention problems. The goal of the emotional exchange intervention is to help mothers provide appropriate stimulation crucial for social, emotional, and neurobehavioral development, by helping the mother and child become attuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternal sensitivity, and mother-child emotional connection will be compared between two groups: one receiving newborn parenting education and the other undergoing facilitated emotional exchange. Assessments will involve videos of mother-infant interactions during each intervention session and follow-up surveys conducted as part of a linked Institutional Review Board-approved study. Data collected in this study will contribute to understanding the underlying mechanisms of mother-infant interactions and their role in shaping optimal neurodevelopmental trajectories for infants and maternal mental health.

Responsible Engaged and Loving (REAL) Fathers Intervention Evaluation

The goal of this stepped-wedge cluster randomized control trial is to assess whether a Ugandan community-based intervention for young fathers (ages 18-25 years) of children ages 0-3 years impacts fathers' knowledge, attitudes, and behaviors surrounding positive parenting practices, father-child interaction, harsh physical punishment of children, and intimate partner violence.

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.

Baby's First Years

Recent advances in developmental neuroscience suggest that experiences early in life can have profound and enduring influences on the developing brain. Family economic resources shape the nature of many of these experiences, yet the extent to which they affect children's development is unknown. The project's team of neuroscientists, economists and developmental psychologists is seeking to fill important gaps in scientific knowledge about the role of economic resources in early development by evaluating the first U.S. randomized controlled trial to determine whether unconditional cash gift payments have a causal effect on the cognitive, socio-emotional and brain development of infants and toddlers in low-income U.S. families. Specifically, 1,000 mothers of infants with incomes below the federal poverty line from four diverse U.S. communities were recruited from post-partum wards and are receiving monthly cash gift payments by debit card for the first 76 months of the child's life. Parents in the experimental group and receiving $333 per month ($3,996 per year), whereas parents in the active comparator group are receiving a nominal monthly payment of $20. In order to understand the impacts of the added income on children's cognitive and behavioral development, the investigators are assessing treatment group differences at ages 4 (this lab assessment was postponed from age 3 to age 4 due to Covid-19), 6, and 8 in lab-administered measures of cognitive, language, and self-regulation development and maternal reports of socio-emotional development. A number of other maternal-reported child outcome measures were gathered at ages 1, 2 and 3. Brain circuitry may be sensitive to the effects of early experience even before early behavioral differences can be detected. In order to understand the impacts of added income on children's brain functioning at age 4, 6, and 8, the investigators will assess, during a lab visit, experimental/active comparator group differences in measures of brain activity (electroencephalography \[EEG\]). The targeted age for each data collection wave is around the child's birthday, i.e. at 12 months, 24 months, 36 months, 48 months, 72 months, and 96 months. To understand how family economic behavior, parenting, and parent stress and well-being change in response to income enhancement, the investigators will assess experimental/active comparator differences in family expenditures, food insecurity, housing and neighborhood quality, family routines and time use, parent stress, mental health and cognition, parenting practices, and child care and preschool arrangements. School readiness and outcomes are being assessed at ages 6 and 8. This study will thus provide the first definitive understanding of the extent to which income plays a causal role in determining early child cognitive, socio-emotional and brain development among low-income families.

Promoting ColorBRAVE Conversations in Families

The objective of this research is to evaluate a mobile app-based intervention for parents of children in K-2nd grade designed that guides them in how to have productive conversations about race with their children. This study will recruit a national sample of parents and their K-2nd grade children. The impact of the intervention is tested using a wait-list controlled trial design. Outcomes include prosocial behaviors and indicators of emotional well-being.

Parenting in the Preschool System in Malaysia

This study aims to evaluate the effectiveness of a hybrid human-digital playful parenting programme, "Naungan Kasih-Hybrid (NK-Hybrid)", in Malaysia. The programme is facilitated by teachers from Malaysian preschools for low-income families, consisting of a) one in-person session to introduce caregivers to the programme, b) teacher-facilitated WhatsApp support groups, and c) an interactive chatbot-led parenting programme featured on WhatsApp, called "Naungan Kasih-Text (NKText)". It tests the effectiveness of this package in a cluster-randomised trial, with 50 preschools as clusters, randomly assigned to either the treatment group or a waitlist control group. Findings from this study will provide evidence for the effectiveness of a low-cost and scalable intervention integrating digital modalities with a "light-touch" in-person component to improve educational outcomes in children attending preschools for low-income families, and thereby address social inequalities in Malaysia. N = 50 Clusters, 772 Primary Caregivers, 304 Secondary Caregivers, and 754 Children. Enrolment reflects participating primary caregivers.

Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation

The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether the association between nutritional supplementation during pregnancy and infant outcomes is partially mediated by reductions in maternal perceived stress and stress reactivity during pregnancy.

Advancing Family Wellbeing Through a Massive Open Online Intervention: The LightBEAM Program

Early childhood is a critical period for developmental outcomes, and the parent-child relationship plays a vital role in shaping cognitive and social development. However, elevated parental distress (e.g., depression, anxiety, anger) can disrupt healthy relationships, increasing the risk of negative child outcomes such as difficult temperaments, altered cognitive development, and socio-emotional challenges. Despite the well-documented effects of untreated parental distress, Canadian families face significant barriers to accessing timely and effective mental health support. To address this gap, our team developed BEAM, an app-based program that provides parenting and mental health resources. BEAM includes expert-led videos, online forums, progress monitoring, and peer-coaching sessions. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. Building on BEAM's success, we have developed the LightBEAM program, which aims to expand these supports into a scalable, accessible, massive online open intervention (MOOI) to reach a larger number of families across Canada, particularly in underserved areas or those on waitlists for individualized services. LightBEAM has the potential to support parental mental health, fostering healthier child and family development while addressing barriers to traditional mental health care. This trial involves a pre-post randomized trial design with primary aims of (1) assessing feasibility and acceptability metrics of LightBEAM including recruitment/retention, sustainability, satisfaction, and unmet needs, (2) examining the efficacy of LightBEAM versus waitlist control at improving family and mental health outcomes, and (3) determine for whom LightBEAM is more or less effective at engaging with and addressing mental health needs. This trial will evaluate the feasibility and effectiveness of LightBEAM with a sample of up to 300 parent participants with a child aged 18-107 months. Co-parents of parent participants are permitted to participate in the study as well but are not included in this sample of 300 parent participants. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app. The LightBEAM program will consist of four different components; weekly parenting and mental health videos, weekly progress tracking, a group forum, and exercises designed to reinforce skills learned through the video content. Assessments of parent and child symptoms will occur at pre-test before LightBEAM begins (T1), immediately after the last week of the LightBEAM intervention (post-test, T2), and 6-month follow-up (T3). The LightBEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related metrics of child well-being. By adapting BEAM, an evidence-based parenting and mental health app, into LightBEAM, a large-scale online intervention, the present trial aims to provide accessible mental health support for Canadian families. LightBEAM could reach families in remote areas with limited services, offer interim support during waitlists, or function as a self-referral program.

The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism

The goal of this pilot RCT is to evaluate the feasibility and acceptability of the community-based sailing program and to assess the preliminary effects before the main RCT, given the literature on sailing for children with ASD has not yet been established. Does intervention improve the resilience of participants? Does intervention improve the quality of life, self-esteem, depressive symptoms, and social functioning outcomes of participants? Researchers will compare the effect of community-based sailing to the attention control group at baseline, following randomisation, and post-intervention Participants will: Participants in the intervention group will participate in a nurse-led community-based sailing programme over six days, with each day consisting of 4 sessions, each lasting an hour, for a total of 24 hours. Participants in the attention control group will engage in crafting activities with minimal difficulty, focusing on maintaining attention without any emotional or reflective discussions.

Empowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach

The purpose of this clinical trial is to learn about the effects of a nursing support program designed for families of children aged 1 to 3 years who have undergone heart surgery. This program aims to improve parents' caregiving skills and support the healthy growth of their children. The primary questions the study aims to answer are: Does the nursing program positively affect the physical growth of children, such as their height and weight? Does the program improve children's scores on general development tests (Denver II)? Do parents' attitudes toward child feeding and their confidence in parenting skills increase? Researchers will divide participants into two groups: Experimental Group: Families who participate in the nursing education program and receive an informative booklet. Control Group: Families who only receive an informative booklet and continue with routine hospital follow-ups. The researchers will compare these two groups to see if participating in the nursing program leads to better results for the children's development and the families' skills. Participants will be asked to: Attend 5 different education and counseling sessions, starting one week before surgery and continuing until the child reaches 1 year of follow-up. Meet with the researcher at specific intervals (at 1, 2, 3, 6, 9, and 12 months) for one year to monitor the child's development (height, weight, head circumference) and skills. Complete surveys regarding child feeding attitudes and parenting skills at the 6th and 12th month follow-ups.

Southampton Women's Survey

The Southampton Women's Survey was established to assess the influence of factors operating before conception and during pregnancy on the health and development of the offspring. 12,583 non-pregnant young women were recruited, and 3,158 were followed through pregnancy, with their offspring followed-up at 6 months and 1, 2, 3, 4, 6-7, 8-9 and 12-13 years. The 17-19 year follow-up has been piloted and is about to start.

Estimating Premorbid Intellectual Functioning in Children and Measuring Change in Cognitive Functioning as Children Develop

Diagnosing and documenting the presence of abnormal change in cognitive functions (such as reasoning abilities) in children over time is of upmost importance when it comes to evaluating the impact of neurological injury, disease, and interventions designed to help improve wellbeing. Unfortunately however, current methods for detecting cognitive impairment and monitoring for abnormal cognitive change in children over time are seriously flawed. By assessing typically developing children's cognitive functioning at two different time points, this study intends to generate new normative data that will significantly improve measurement accuracy when it comes to evaluating the impact of neurological injury and disease on a child's cognitive abilities.