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Child Development clinical trials

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NCT ID: NCT05755178 Enrolling by invitation - Child Development Clinical Trials

Musical Group Intervention for Children in Shelters

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The aim of the study is to augment knowledge on interventions for children who live, or have lived, in shelters after exposure to domestic violence. Research questions concern the feasibility of a music group intervention for children. The experiences of children, caregivers, and professionals will be investigated. Additionally, outcomes concerning emotional reactivity, capacity for emotional regulation, quality of life, and psychological health will be evaluated.

NCT ID: NCT05551650 Enrolling by invitation - Child Development Clinical Trials

El Sendero: Pathways to Health Study

Start date: September 1, 2021
Phase:
Study type: Observational

This project will continue to follow two birth cohorts of mother-infant Latino dyads through a series of new assessments at age 6y, with an emphasis on examining the the role early nutritional exposures, exposures to environmental toxins, and social determinants of health have on adiposity, eating behaviors, brain structure and function, cognitive outcomes, and chronic disease risk.

NCT ID: NCT05191823 Enrolling by invitation - Preterm Birth Clinical Trials

Omega Tots Long Term Follow-up

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.

NCT ID: NCT05178290 Enrolling by invitation - Exercise Clinical Trials

Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers

BESAGE
Start date: November 22, 2021
Phase: N/A
Study type: Interventional

This study aims to get children safely back to school by (1) Child and Family Testing, (2) ECE Personnel Testing, and (3) Outdoor Learning via Garden Education.

NCT ID: NCT05119959 Enrolling by invitation - Child Development Clinical Trials

Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving

ZICS-BOOST
Start date: April 14, 2022
Phase: N/A
Study type: Interventional

Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. In Zambia, there are existing effective early childhood developmental (ECD) interventions that target other vulnerable populations, but never trialed specifically for CHEUs. Scaling up ECD is now a priority of Zambia's national strategy, but CHEUs are not currently targeted. There is a need to better understand the scope and mechanism of CHEU-related neurodevelopmental differences and what interventions are most effective. This randomized clinical trial (RCT) is a true effectiveness trial as the intervention will deploy a home-based adaptation of the same curriculum that is currently used elsewhere in the country, named Scaling Up Early Childhood Development In Zambia (SUPERCDZ). The effectiveness of a scalable early childhood development (ECD) intervention for CHEUs will be evaluated using normalized Z-scores of neurodevelopmental testing at age 24 months. In this RCT the investigators will test the following hypotheses: Hypothesis 1: An ECD intervention delivered by community health workers via bi-weekly home visits will improve neurodevelopmental outcomes in CHEUs. Hypothesis 2: CHEUs have significantly worse neurodevelopmental outcomes than unexposed peers at 24 months, mediated by preterm birth, disease stage or antiretroviral (ARV) exposure. This RCT will build on an existent, actively recruiting cohort of 1500 pregnant women-infant dyads in a peri-urban hospital in Zambia, the Zambian Infant Cohort Study (ZICS), by extending the follow-up of a subsample of infants from 6 months to 2 years amongst the last 525 children enrolled (ZICS-BOOST- Brains Optimized to Survive and Thrive). The study will have three arms: Arm 1) CHEU + ECD intervention (n=175); Arm 2) CHEU without ECD intervention (n=175); Arm 3) HUU without intervention (n=175).

NCT ID: NCT04639557 Enrolling by invitation - Child Development Clinical Trials

Building Regulation in Dual Generations - Telehealth Model

BRIDGE
Start date: September 1, 2020
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. A feasibility study has been conducted in-person (NCT04347707). Results from this trial showed positive effects on child and mother well-being as well as parenting skills. 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 objectives for this study are two-fold: 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) evaluate a novel dual-generation intervention for mothers with mental illness using a virtual format and their 3- to 5-year-old children based on existing gold-standard evidence-based approaches.

NCT ID: NCT04398901 Enrolling by invitation - Child Development Clinical Trials

Neurodevelopmental Outcomes in ZIKV-Exposed Children

Start date: November 23, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT03281980 Enrolling by invitation - Child Development Clinical Trials

Effects of Psychosocial Stimulation and Cash on Children's Development and Behaviour

Start date: August 20, 2017
Phase: N/A
Study type: Interventional

Burden: In developing countries, an estimated 219 million children do not reach their maximum potentiality because of poverty and associated risk factors. More than half of the Bangladeshi children <5 years are at risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic expenditure on health care and fall into the vicious cycle of poverty Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor people' health and nutritional status, little is known about the effect of unconditional cash transfer and health education (HE) programmes along with psychosocial stimulation on children' cognition and behaviour. Relevance: The study will bring an opportunity to evaluate the effect of transferring unconditional cash and health education programme along with psychosocial stimulation to poor families under safetynet programme of Bangladesh Govt. in rural areas. The study will also document direct and indirect cost to measure cost effectiveness that will help in decision making to implement the project if it shows benefits to children's development. Primary Hypothesis (if any): - Unconditional cash transfer (UCT) and health education (HE) programme will improve child's cognitive, motor and language development and behaviour compared to no intervention group. - Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health education (HE) programme will will have an additive effect on Childs's cognitive, motor and language development and behaviour compared to the control groups Secondary Hypothesis: Additionally the intervention will - be cost effective, - reduce mothers' depressive symptoms and improve their self esteem - improve children's growth and household food security status - reduce domestic violence - Health seeking behaviour and health care expenditure Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early child development activities for the whole country. Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial stimulation (ii) UCT+HE and iii) Comparison group.

NCT ID: NCT02718287 Enrolling by invitation - Child Development Clinical Trials

Evaluation of the Home Visiting Pilot Program on Early Childhood Outcomes in Fortaleza Brazil

Start date: March 2016
Phase: N/A
Study type: Interventional

This is a cluster-randomized study of a home visiting program targeting mothers of children 0 to 2.5 years of age with the objective of improving global child development. The program, Programa Cresça com Seu Filho (PCCSF), will be randomized across 220 microareas in the poorest Region (V) of the state of Fortaleza, Brazil.