300,000+ clinical trials. Find the right one.

62 active trials for Child Development

WASH Benefits Bangladesh

Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.

Start: May 2012

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.

Start: January 2016

CLC Parent-Child Emotional Preparation Program

The purpose of this study is to investigate the feasibility of the Nurture Science Program's (NSP) Drop-In group via telemedicine as standard care at Children's Learning Centers (CLC) to prepare preschoolers emotionally for the preschool experience utilizing the Welch Emotional Connection Screen (WECS) Relational Health Toolkit. The behavioral, neurobiological, and clinical insights gained from this project may lead to better treatment of emotional, behavioral and developmental disorders.

Start: April 2021

Factors Affecting Newborn Body Composition and Later Health in Helsinki Birth Cohort 2018-2022

In Helsinki Birth Cohort 2018-2022 a large, longitudinal and well-phenotyped birth cohort of infants and their parents will be established. Mothers, fathers/spouses and their children in Helsinki and Uusimaa Hospital District are recruited in the study and newborn composition of the children born in Helsinki Women's Hospital will be measured. Data on maternal and paternal diet quality, physical activity and depression during and after pregnancy will be collected and data from the hospital and national registers will be collected. Health of offspring and parents will be followed during their later life.

Start: December 2018

WASH Benefits Child Development Follow up

The purpose of this study is to determine if the effects of individual and combined water, sanitation, hygiene, and nutrition interventions in early childhood on child development and maternal mental health persist into middle childhood. This study is a follow-up assessment of the children and mothers enrolled in the WASH-Benefits Bangladesh study.

Start: September 2019

Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.

Start: January 2021

Building Regulations in Dual Generations at KIDTHINK

Neurodevelopmental disorders (NDDs) such as attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), and intellectual disability (ID) are the most frequently diagnosed disability in children, accounting for 7% to 14% of children in developed countries. Developmental concerns emerge early, providing an opportunity to support families years before a diagnosis may occur. Emerging concerns are often predictive of problems with self-regulation, risky behaviours (e.g., substance abuse and over-eating), academic achievement, social functioning, parent-child relationship, and lower overall quality of life. Overall family wellbeing is also commonly affected given the increased challenges faced by parents and caregivers, including socioeconomic disadvantage. Parents facing hurdles to positive parenting, such as poor psychological wellbeing, may struggle further with parenting capacity in the context of the increased parenting demands of caring for a child with specific needs. The objective of this study is to create a novel adaptation of an existing program that is targeted at improving the mental wellness and parenting practices of caregivers (mothers, fathers, guardians) with elevated symptoms of depression who have 3 to 8-year-old children with emerging behavioural, emotional, or developmental concerns. It is hypothesized that taking a dual-generation intervention approach to addressing self-regulatory mechanisms underlying psychopathology at the level of the caregiver, child, and dyad (i.e. parenting interactions) will improve both caregiver capacities and child outcomes. Further, it is hypothesized that this novel adaptation of the program will be tailored to meet the identified needs of this demographic and that the program will show improvement in psychosocial, emotional, and parenting function compared to a services as usual control group. Our current study will be conducted remotely due to the COVID-19 pandemic to adhere to public health guidelines to reduce in-person contact and physical distance. The ultimate goal of this project is to improve parent wellbeing and promote supportive parenting practices that allow children with early developmental needs to reach their full potential.

Start: April 2021

Neurodevelopmental Outcomes in ZIKV-Exposed Children

In this study the investigators will follow the neurodevelopmental outcome of children with in utero ZIKV exposure who do not have microcephaly or severe abnormalities consistent with Congenital Zika Syndrome. The ZIKV-exposed children will be compared to non-ZIKV exposed controls. Children will be assessed at age 3 and 4 years using standardized neurodevelopmental assessments. Children will also have neurodevelopmental assessment at age 5 and 7 years along with a brain MRI at age 7 years.

Start: November 2020

Prenatal Depression Prevention Effects on Parenting and Young Child Self-Regulation and Functioning

Poor parenting practices and compromised child self-regulation when a child is 2 ½ - 4 ½ years old are foundational in promoting their later healthy development and adaptive functioning. This project will test whether targeting depressive symptoms with a prenatal preventive intervention prevents disruptions in well-regulated parenting and child self-regulation known to affect families with depressed mothers. This project may have great benefit to society, as preventive interventions delivered prenatally have the potential to influence long-term trajectories of parenting practices and child development which, in turn, can chart a course for future child health and well-being.

Start: November 2019

Early Childhood Outside (ECO) - Randomized Controlled Trial Study

Outdoor play is important for children as it can promote healthy social and physical development, emotional well-being, self-confidence, risk management and overall physical activity. Yet, opportunities for outdoor play have been decreasing across generations due to perceptions that it is dangerous and unnecessary. Early childhood educators (ECEs) and administrators are struggling to provide children with high quality and stimulating outdoor play time. To help ECEs and administrators, the investigators have developed a Risk Reframing (RR) digital tool, https://outsideplay.ca, which is underpinned by social cognitive theory (SCT) and health behaviour change techniques. The aim of the current study is to test the efficacy of the RR digital tool in: 1) increasing ECEs/administrators' tolerance of risk in play; and, 2) attaining their behavior change goal in promoting children's outdoor play at their early childcare center. The investigators will conduct a single-blind (researchers and outcome assessors) randomized controlled trial and will obtain complete data on at least 206 early childhood educators and administrators currently working in Canada. The RR digital tool is designed for a one-time visit and includes three chapters of self-reflection and experiential learning tasks. The control condition consists of reading the Position Statement on Active Outdoor Play, a 2-page information sheet on children's active outdoor play. Primary outcome is increased tolerance of risk in play, as measured by the Tolerance of Risk in Play Scale - teacher version. Secondary outcome is self-reported attainment of a behaviour change goal that participants set for themselves. The investigators will test the hypothesis that there will be differences between the intervention and control conditions with respect to tolerance of risk in play and goal attainment.

Start: December 2020

Bandebereho 6 Year Follow up RCT in Rwanda

This study seeks to conduct a six-year follow-up of the Bandebereho randomized control trial (RCT) to assess the longer-term impact of the gender-transformative Bandebereho couples intervention on participating men, women, and their children. The Bandebereho program was implemented by the Rwanda Men's Resource Centre (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local authorities between 2013 and 2015. A two-arm RCT collected three rounds of data from 1,199 couples (575 treatment; 624 control) starting in 2015-16: baseline (pre-intervention), 9 month follow-up, and 21-month follow-up. The findings at 21-months demonstrated significant impacts of the intervention on multiple gender and health-related outcomes. This study will conduct surveys with men enrolled in the RCT and their female partners 6 years after the intervention, to assess its long-term impact on reproductive and maternal health, gender attitudes and household dynamics, intimate partner violence, mental health and wellbeing, parenting, and child development. In addition, child assessments will be conducted with a sub-sample of 800 children aged 4 to 7 years to directly assess early childhood development outcomes.

Start: April 2021

Strengthening Bangladeshi Babies Brains (SBBB)

This study aims to establish a sustainable programme whereby early childhood development activities are integrated into the routine activities of community clinics in rural Bangladesh for undernourished children by developing a cascade of training at national, district, Upazila (sub-district), and union level to train clinic staff.

Start: July 2021

Comparing Rater Reliability of Familiar Practitioners to Blinded Coders

The purpose of this study is to determine how coders who have seen multiple time points of the same dyad, and are therefore familiar with the case, rate emotional connection using the WECS compared to coders who are blinded to the case's previous time points. The investigator hypothesizes that the WECS will show external validity: that all coders will have high reliability on their WECS scores, despite exposure to the dyads' past videos by the clinical coders.

Start: September 2018

Students Education Training in Emotional Connection

The purpose of this study is to assess the effectiveness of different educational modules in training graduate students from Columbia University Irving Medical Center campus and from the Columbia School of Social Work to assess the emotional connection of mother/child dyads with accuracy. The investigators hypothesize that after completing the educational module involving recorded dyad interactions, subjects will achieve coding reliability with the PI.

Start: September 2018

LEAPS-NCHD Program Evaluation

An estimated 88 million children drop out of primary school each year worldwide, and the highest number of dropouts are in the first and second grade. A proven strategy to reduce dropout from primary school is participation in early childhood care and education (ECCE) services that bolster young children's health, development and readiness for school. Access to quality ECCE services remains highly limited in Pakistan: less than 50% of four-year-olds are estimated to attend ECCE services, and skilled ECCE workers remain scarce. To address these challenges, LEAPS (Youth Leaders for Early Childhood Assuring Children are Prepared for School) was developed as a cross-generational strategy to support the learning and development of young children (3.5- to 5.5-year-olds) and female youth (18- to 24-year-olds). The program provides vocational training to female youth, referred to as Community Youth Leaders (CYLs), to deliver a community-based preschool program in rural Sindh, Pakistan. The LEAPS program was previously developed in partnership with Pakistan's National Commission for Human Development (NCHD), a government entity charged with supporting community health, education, and vocational training programs. Efficacy and feasibility of the LEAPS strategy were demonstrated through a prior pilot evaluated in a cluster-randomized controlled trial in 2015 (NCT02645162). The NCHD is now seeking to integrate the LEAPS program within their full suite of services and to scale the program across 99 villages in rural Sindh under the technical guidance and support of a local implementation support team led by the Aga Khan University. This intervention utilizes two strategies: i) the first is the implementation of the LEAPS program, led by NCHD; and ii) the second is the technical support of the NCHD, to ensure the system is able to support program expansion and sustainability. This study uses a cluster-randomized stepped-wedge design with three steps to assess program impact on school readiness and child and youth development outcomes across the 99 villages ("clusters"). All clusters will begin in the control state (i.e. access to standard community services). Prior to the start of the trial, clusters will be randomized to 'cross-over' to the intervention state (i.e. introduction of the LEAPS-NCHD program) during one of three sequential steps. Each step will be approximately 9-11 months. By the end of the trial, all clusters will have been exposed to the intervention. Measurement is assessed across all clusters at each step. The total duration of the trial will be 31 months. A process evaluation will also be conducted to examine the large-scale implementation of the LEAPS-NCHD Program.

Start: January 2019

The Influence of Interactive Media on Child Development in Children

Introduction: In the last decade the prevalence of the use of interactive media (smartphone, tablet) by children has grown worldwide. However, it is not yet known what its effects are on the development of children in early childhood and whether the form of use (passive or active) influences this practice. In view of this, the present study aims to assess, through a randomized clinical trial (RCT), whether the form of use of mobile interactive media interferes with the Methods: The investigators propose an RCT with 64 children aged 24 to 36 months and their parents. Initially, identification, information about the child and history of media use will be carried out through the Questionnaire on the Use of Interactive Media, economic classification (Brazil Economic Classification Criterion). Then, the quality of the school environment (Infant / Toddler Environment Rating Scale) will be observed and, finally, measures of cognitive, motor and language development through the Bayley III Scale and Auditory Vocabulary Test. For follow-up purposes, parents will be asked to complete the Daily Record Board. Children will be randomly randomized into two groups: Active Interactive Media Group: children will use the media actively (games) and Passive Interactive Media Group: children will use the media passively (content viewing). Both groups will participate in the intervention for 30 minutes, three times a week, for 16 weeks. After this period, children will be reassessed for cognitive, language and fine motor development, receptive vocabulary and analysis of the Daily Record Board. Discussion: The results can provide (1) information on which form of use has the most benefits for children (2) guide parents, educators and health professionals on how to offer interactive media. Trial registration: This clinical trial was submitted to and approved by the Research Ethics Committee of Universidade Federal dos Vales do Jequitinhonha e Mucuri (CAAE 29490420.9.0000.5108). The complete protocol was registered in the Clinical Trials REBEC ( https://ensaiosclinicos.gov.br) under number RBR-8j3tzw Keywords: Child Development, Tablet, Interactive Tutorial, Clinical Trial.

Start: August 2021

Baby's First Years

Recent advances in developmental neuroscience suggest that experiences early in life 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. Our team of neuroscientists, economists and developmental psychologists proposes to fill important gaps in scientific knowledge about the role of economic resources in early development by evaluating the first 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 will receive monthly cash gift payments by debit card for the first 40 months of the child's life. Parents in the experimental group will receive $333 per month ($4,000 per year), whereas parents in the active comparator group will receive 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 will assess experimental/active comparator group differences at age 3 (and, for a subset of measures, age 2) on measures of cognitive, language, memory, self-regulation and socio-emotional development. 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 3, the investigators will assess, during a lab visit, experimental/active comparator group differences in measures of brain activity (electroencephalogram [EEG]). 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 arrangements at child age 2 and, for a subset of these measures, child age 1. 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.

Start: May 2018

Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P Study)

Shanghai is one of pilot areas for the early education of 3-6 years old infants in China. Shanghai Municipal Education Commission has been actively exploring more effective early education guidance methods. This survey, in the form of online questionnaire and site test, aims to dynamically evaluate the changes in the early development level of children in Shanghai and provide scientific basis for providing better early education services in the future.

Start: September 2016

A Study to Compare the Long-term Outcomes After Two Different Anaesthetics

There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.

Start: August 2017

School-Based Mental Health Effectiveness Study

This study involves efforts to advance the science of prevention in early childhood mental health in low-resource communities. Investigators will assess the effectiveness, practical implementation strategies, and underlying mechanisms of the evidence-based intervention, ParentCorps-Professional Development, in urban and rural Uganda. Two implementation approaches, with and without the teacher stress management package, T-Wellness, will be compared for efficacy.

Start: June 2021