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Child Development clinical trials

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NCT ID: NCT04347707 Terminated - Depression Clinical Trials

Building Regulation in Dual Generations

BRIDGE
Start date: September 15, 2019
Phase: N/A
Study type: Interventional

Families who experience maternal mental illness and a variety of chronic stressors are currently underserved by the parenting programs. The investigators propose that impairments in maternal self-regulation, which result in unsupportive parenting, directly impact children's own self-regulation and neurobiology, leading to risk for intergenerational transmission of mental illness. The objective of this study is to develop and evaluate a program that is targeted at improving underlying self-regulatory mechanisms in both mothers with depression and their 3 to 5-year-old children. It is hypothesized that children exposed to maternal mental illness will have greater self-regulatory deficits across emotional and behavioural domains, compared to children not exposed to mental illness. The effects of maternal mental illness are expected to be compounded for children of mothers reporting a higher degree of chronic stressors, including poverty, housing instability, violence, and low social support. Further, it is hypothesized that taking a dual-generation intervention approach to addressing self-regulatory mechanisms underlying psychopathology at the level of the mother, child, and dyad (i.e. parenting interactions) will improve both maternal capacities and child outcomes. The objectives for this study are to 1) establish a better understanding of the self-regulatory processes that are altered in preschool-aged children exposed to maternal mental illness, and determine the mediating role of parenting behaviours, as well as the moderating impact of chronic stress exposure; and 2) develop and evaluate a novel dual-generation intervention for mothers with mental illness and their 3 to 5-year-old children based on existing gold-standard evidence-based approaches.

NCT ID: NCT04233489 Terminated - Child Development Clinical Trials

Clinical Interventions to Mitigate Neurodevelopmental Risk

Start date: January 3, 2020
Phase: N/A
Study type: Interventional

Family Nurture Intervention (FNI) has been shown to facilitate emotional connection and long-term child developmental progress in the NICU population. It has been theorized that FNI also promotes autonomic co-regulation and physiological synchrony between the mother-child dyad. The goal of the pilot study is to assess how a short one-time FNI session between at-risk mother and child dyads in the Well Baby Nursery (WBN) influences physiological synchrony, emotional connection, and developmental changes both short and long-term.

NCT ID: NCT04210362 Terminated - Child Development Clinical Trials

External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican NGO Un Kilo de Ayuda

NPECDP-UKA
Start date: July 15, 2019
Phase: N/A
Study type: Interventional

Investing in early childhood development is one of the best cost-effective investments a country can make to boost long term economic growth, promote peaceful and sustainable societies, contribute to tackle poverty traps and eradicate inequality. It is also necessary to uphold the right of every child to survive and thrive. The single most powerful context for nurturing care is the immediate home, often mainly provided by mothers. Although the Mexican government has implemented social programs in the past, some with nutrition and child development components, poor and isolated communities have not benefited as others easier to reach. This is particularly true for the State of Oaxaca given its orography, where higher levels of malnutrition and a higher risk of suboptimal neurodevelopment are present. Since 1989, Un Kilo de Ayuda A.C. (UKA), a nongovernmental organization, has been involved in preventing child undernutrition in contexts of high poverty. Currently, UKA has 9 Early Childhood Development Centers distributed in 5 States of Mexico, including Oaxaca. UKA has developed the Neurological and Psycho-affective Early Childhood Development Program (NPECDP-UKA) that seeks to contribute to timely stimulation in children under 5 years of age and promote perceptual parenting practices. As part of the NPECDP-UKA, UKA redesigned their interventions to promote healthy nurturing care practices and responsive caregiving through workshops provided to caregivers and pregnant women, and with reinforcement through home visits. It is in the interest of this study to evaluate the NPECDP-UKA through a variation of a stepped wedge cluster randomized trial. The study sample consists of participants from 80 municipalities of Oaxaca (~50% with high or very high margination status), 20 municipalities were randomly assigned to each arm. Study arms differ by design on the time of exposure to the program (0,18,24 and 30 months at the final measurement). Subjects from all study groups share the characteristic to be enrolled in the NPECDP-UKA, the group with 0 months of exposure will serve as a comparison group. This distinctive characteristic of the study requires a progressive incorporation of study groups to be able to compare development measurements between study groups at the same ages and among subjects all enrolled in the program to avoid self-selection bias. The main study hypothesis states that children exposed to the Program will have better neurodevelopment outcomes than those not exposed. This study will provide evidence of the effect of an educational intervention for caregivers on the neurodevelopment of children under 5 years of age. Currently evidence of such interventions is very limited, especially for interventions performed by a nongovernmental organization. This is the first evaluation of this kind in Mexico.

NCT ID: NCT04075071 Terminated - Child Development Clinical Trials

A Pilot Study of Teacher-Child Interaction Training - Universal in Head Start

TCIT-U
Start date: September 12, 2019
Phase: N/A
Study type: Interventional

This pilot study aims to implement and evaluate Teacher-Child Interaction Training - Universal (TCIT-U), an empirically-supported classroom-based intervention aimed at improving child behavior and social-emotional skills through strengthening teacher-child relationships at a preschool that serves children from socially and economically disadvantaged backgrounds who are at risk for behavioral health difficulties. The main objectives are to (a) examine TCIT-U's effects on teacher behavior, teachers' sense of efficacy, and child behavior problems and social-emotional skills compared to usual care (UC) and (b) explore the feasibility and acceptability of implementing TCIT-U at a diverse urban preschool.

NCT ID: NCT04069000 Terminated - Child Development Clinical Trials

Mind Up (MindUP) Evaluation With Grade 3 Students

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Mind Up (MindUP) is a mindfulness-based social-emotional learning program for children that has shown promising evidence of effectiveness across several domains (including executive functioning and behavioral symptoms). MindUP has exploded in popularity in recent years, but much of the existing research is limited by sample size, lack of accounting for clustering, or has been conducted by the program developers. In this study we are evaluating MindUP with grade three students (~age 8) in three conditions; students who receive MindUP for the first time (n=~150 in 8-10 classrooms), students have been receiving MindUP since kindergarten (~150 in 8-10 classrooms), and students in comparison classrooms (i.e., no intervention; ~150 students in 8-10 classrooms). Regular classrooms teachers will receive training in trauma-informed approaches and the MindUP program prior to implementing. Students will be assessed in the fall and at the end of the school year using structured rating scales; they will also provide self-report data. In November 2020, students' grade 4 teachers will provide another set of ratings to be used as 6-month follow-up data. The primary outcome is social-emotional learning. Secondary outcomes include executive functioning, academic skills, classroom climate, and self-concept.

NCT ID: NCT03866616 Terminated - Child Development Clinical Trials

Evaluation Study of the Impact of the New Brain Builders Parenting Class

Start date: June 24, 2019
Phase: N/A
Study type: Interventional

The objective of this research is to evaluate the effectiveness of the parenting program on increasing positive parent-child interactions and increasing cognitive achievement in children. Overall, this project is intended to benefit women and children and supplement WIC services. The Brain Builders Parenting Class Evaluation Study Research Questions include the following: 1. Does the program impact child development outcomes such as kindergarten readiness? 2. Does the program increase parental knowledge about the importance of high-quality parent-child interaction for child development? 3. Does the program impact the quality and quantity of the parent-child interactions?

NCT ID: NCT03847675 Terminated - Child Development Clinical Trials

Reach Out and Read Arabic to Promote Arabic Literacy in Toddlers

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The goal of this study is to encourage parents to read Arabic books to their children from an early age and by extension children will be more likely to read Arabic books and ultimately improve their Arabic literacy. The investigators' hypothesis is that an adapted "Reach Out and Read" program will result in an increase in the proportion of parents reading Arabic books to their children after the intervention.

NCT ID: NCT02619006 Terminated - Child Development Clinical Trials

Infant Brain Study Follow-Up at 3 and 4 Years of Age

Start date: November 2015
Phase:
Study type: Observational

When immediate clamping of the umbilical cord (ICC) occurs at birth, 20 to 30% of the fetal-placental blood volume is left behind in the placenta. Preliminary results from our current study comparing effects of ICC versus placental transfusion from delayed cord clamping (DCC) show that infants who have DCC have higher ferritin levels at 4 months of age and more myelin in important regions of the brain. Our objective for this follow-up study is to see if the effects of placental transfusion persist to three and four years of age. The investigators plan to enroll only children who participated in the previous trial (Infant Brain Study/NCT01620008) at birth for assessments at three and four years of age. Assessments include MRIs and neurodevelopmental testing to examine cognitive, motor, visual, and behavioral outcomes. The proposed research addresses two central questions regarding the potential benefits of DCC on brain myelin development in children who were born healthy at term: 1. Does DCC result in increased brain myelin deposition at three and four years of age? and 2) Are DCC, iron stores, and brain myelin content in infancy associated with improved cognitive, motor, and socio-behavioral outcomes at three and four years of age?

NCT ID: NCT00862147 Terminated - Child Development Clinical Trials

Effectiveness Study of the International Child Development Program

Start date: January 2007
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the effect of the International Child Development Program (ICDP). Research questions to be answered: 1. Does the ICDP affect children's psychosocial functioning compared to treatment as usual? 2. Does the ICDP change parent-child interaction?