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NCT07418528
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.
NCT04512352
The poverty rate among children under 18 years old in Hong Kong in 2015 was 18% after social welfare intervention. James Heckman, a Nobel Prize winner in Economics, advocates early childhood investment to enhance social mobility, given its lifelong impact of on child development. However, few randomized control trails have been used to examine the effectiveness of early childhood intervention in promoting social mobility through child development in Hong Kong. To fill these gaps, we propose an interdisciplinary intervention study involving academics from economics, sociology, social work, gerontology, education, and psychology to investigate methods to promote the social mobility of children living in poverty through early intervention. The overall objective is to enhance the developmental outcomes of children in poverty by utilizing parental resources within a family system, technological resources available in modern metropolis and the human resources enjoyed by the elderly in Hong Kong. The primary objective is to evaluate an internet- and family-based intervention to promote the development of children in poverty enrolled in the first year of Hong Kong's nurseries, who are mostly aged 24 months to three years. The examined outcomes will be the developmental well-being of participating children and parenting attitudes and behaviors, with the long-term goal of promoting their social mobility to break the cycle of poverty. In the long run, we aim to establish the proposed intervention in policy to promote the development of disadvantaged children. The secondary objective is to identify intergenerational volunteerism as a means for productive aging through a mentoring program using older adults as mentors to participating parents.
NCT04111016
The goal of this study is to assess the feasibility of implementing a group-based integrated early child development intervention through the government health system in one sub-district of Bangladesh, and to assess the resulting uptake of the intervention in the target population.
NCT04114305
With increased use of effective strategies to prevent HIV transmission from women to their infants, the number of HIV infected children has dramatically decreased. This has led to an increased number of children who have been exposed to HIV, but who are not themselves infected. There is concern that exposure to HIV can lead to poorer health outcomes, including less optimal neurodevelopment. Because of this possibility in a growing population of HIV-exposed, but uninfected (HEU) children, there is a need to identify interventions to optimize their growth and development. This study was undertaken to evaluate the impact of a two-generation intervention, jointly targeting child neurodevelopment and maternal psychosocial wellbeing, integrated into antenatal care/prevention of maternal to child transmission (ANC/PMTCT) clinics. The intervention was implemented by mothers2mothers (m2m), an organization based in South Africa with a long-standing program using peer mentors (Mentor Mothers) to support HIV-infected women and their families. The m2m ECD intervention provided by specially trained Mentor Mothers included home- and community based activities meant to assist mothers and other caregivers in building resilience and gaining skills to support their children's development. The primary intervention was an intensive program of home visits beginning during pregnancy and continuing until the child reached two years of age, with up to 46 home visits. At each visit, the ECD Mentor Mothers helped parents/caregivers to learn about ages and stages of growth (including pre-birth), and to facilitate responsive parenting and early learning opportunities for their children. Mentor Mothers also conducted parenting information play groups (PIPs) in each community for ECD clients and ECD information was integrated into the existing facility support groups provided at each health clinic. The intervention covered general areas of maternal and child health, nutrition, social services, support for primary caregivers and stimulation for early learning. Since the intervention was targeted at two generations, the primary aims were two-fold: to assess the impact on pediatric neurodevelopment and on maternal psychosocial function. Secondary aims included assessment of maternal and child retention in care, maternal HIV outcomes and child mortality, health, growth and nutrition. Children were enrolled into one of two study arms: 1) the intervention arm included children from clinics where the m2m ECD program was being implemented, and 2) the comparison arm included children from government clinics that offered standard of care services but no m2m or ECD program. Mothers were enrolled during antenatal care, in the third trimester of pregnancy. Children and their mothers were followed though 18 months of age and their evaluation included an assessment of development (Mullen Scale of Early Learning) at 9 and 18 months, as well as assessments of child growth, maternal psychosocial well-being, parenting practices and retention in care.
NCT03195036
There is substantial evidence that early childhood development (ECD) programming can improve child health and development outcomes. An important component of ECD programming is supporting positive parenting and early stimulation practices. While many parents could benefit from such programming, mothers that are HIV-infected may particularly benefit given the higher risks of poorer child development among HIV-exposed children. Catholic Relief Services (CRS) in Cameroon is implementing the Key Interventions to Develop Systems and Services (KIDSS) ECD program for HIV-exposed children. This impact evaluation will ascertain to what extent the KIDSS home-based component of the ECD model affects attainment of age-appropriate developmental milestones (measured by the Ages and Stages Questionnaire 3 (ASQ-3)) in HIV-exposed children in Cameroon. The study design is a cluster-randomized controlled trial with a cohort of 200 mother/child dyads across 10 study clinics. HIV+ mothers will be recruited during pregnancy and their children will be followed up until 18 months of age. The intervention group will receive regular home-based ECD services focused on positive parenting and early stimulation. The control group will not have any exposure to ECD services, though they may receive home-based services focused on HIV care and treatment, hygiene, and nutrition. Randomization occurs at the clinic (cluster) level.