Child Development Clinical Trials

The goal of this clinical trial is to test the Nurse Family Partnership (NFP) in mothers with previous live births (multiparous or multip individuals). The main aims are: Specific Aim 1-Determine the effectiveness of NFP among multiparous women for reducing maternal morbidity and improving pregnancy outcomes. Specific Aim 2-Determine the effectiveness of NFP among index children (child from pregnancy when mother was enrolled) of multiparous women for improving child outcomes. Specific Aim 3 (Exploratory)-In preparation for a future study of the effects of preventive home-visiting programs on mother-index child-sibling triads, describe siblings (characteristics, role, influence) in the context of nurse home-visiting and evaluate the effectiveness of NFP on outcomes for prior-born siblings younger than 6 years old living in the home, including cognitive development, socioemotional development, and identification and referral to needed services. Read Less

The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD). Read Less

The goal of this observational study is to build psychometric evidence for the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) provider questionnaire. The main objectives of the study are to: 1) assess the reliability of the HBCC-NSAC Toolkit provider questionnaire, 2) assess the evidence for its validity compared to other existing measures of HBCC quality, and 3) examine invariance across subgroups (that is, look for the absence of any differential item functioning [DIF]). HBCC provider participants will complete a questionnaire in the HBCC-NSAC Toolkit. A subset of providers will also participate in an observation of their child care setting. Parents or guardians of children receiving care from HBCC providers will complete a survey. Read Less

The goal of this clinical trial is to examine the impact of an educational intervention on infant motor skill development. The main question it aims to answer is: Question 1) Does exposure to an educational intervention on infant development positively impact infant motor skill development? Researchers will compare the intervention group to the treatment as usual group see if there are differences in infant motor skill development. The purpose of the proposed study is to determine if tummy time, play positions, screen time, and use of baby gear impacts early motor skill development in children. This is a Pilot study. A Pilot study is a small study that is carried out to collect information that will help in the planning of a larger study with the same topic. Read Less

Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development. There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes). Read Less

Sleep disturbances are pervasive and impairing among children who spend time in foster care but not a single prevention or intervention program for this fragile group targets sleep health. Poor sleep undermines effective self-regulation and stable biological rhythms, amplifying the negative impacts of early adversity/trauma on immediate and long-term functioning. Consistent with evidence that optimizing sleep is critical for trauma recovery, the investigators will adapt cognitive-behavioral treatment for pediatric insomnia for children placed in or adopted from foster care to evaluate child outcomes and target mechanism engagement and explore implementation barriers and supports. Read Less

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. Read Less

During the Coronavirus (COVID-19) pandemic many families are using video chat (e.g., Zoom) to maintain relationships with distant relatives, including grandparents. While 67% of all grandparents reported liking the idea of video chatting with their grandchildren, only 28% did so regularly. Increasing this percentage could significantly improve grandparent-grandchild relationships because the Preliminary Study 1 showed that video chat frequency is a strong predictor of grandparent's ratings of closeness to their grandchild, even after controlling for the geographic distance between them. The overall goal of the past, ongoing, and future research is to understand the cognitive and social developmental challenges of video chat in order to support its use with children. As the next step towards this goal, the investigators propose to directly compare two approaches to instructing grandparents on how to improve video chats between grandparents and young grandchildren (18-72 months of age). Families will use video chat without the involvement of researchers during each video chat. Parent-child- grandparent triads (n=180; the largest multi-session observational study of young children and video chat to date) will record 10 video chats under one of three randomly-assigned conditions: structured play, structured reading, or when given no instructions (control). The overall hypothesis is that structured video chat will increase children's engagement and joint attention (primary outcome measures), as well as grandparents' enjoyment of video chat and closeness with their grandchild (secondary outcome measures). The investigators will use detailed behavioral coding of the video recordings of these chats to objectively assess many of the outcome measures. The Preliminary Study 2 showed that structured video chat facilitates more positive social interactions. The proposed work extends the preliminary work because it translates laboratory methods to a complementary ecologically-valid approach in families' naturalistic environments. In Aim 1, the investigators will determine whether and for whom structured video chat improves child engagement and increases child-initiated screen- based joint attention during video chats between grandparents and grandchildren. In Aim 2, the investigators will determine whether structured video chat increases grandparents' enjoyment of the video chats and leads to greater feelings of closeness to their grandchild. Both principal investigators, who are at R15-eligible institutions, are well-qualified to complete the proposed work. Since 2017, they have published 9 papers on video chat, 12 papers on reading, and collaboratively completed 3 preliminary studies and 2 papers. They have mentored 77 undergraduate students, many of whom were co-authors on conference posters or presentations (37 students in total; 22 as a presenter) or journal articles. Importantly, 17 students came from underrepresented groups (BIPOC, first- generation in college, LGBT). A total of 47 are pursuing or have completed graduate work in health-related sciences, including 15 for doctoral degrees. The proposed work addresses a National Institute for Child Health & Development, Child Development and Behavior Branch's (CDBB) priority of advancing understanding of "Effects of Technology and Digital Media Use on Child and Adolescent Development." Read Less

The objective of this research is to evaluate a multi-module "color brave" app-based intervention for parents of children in K-2nd grade, that guides them in how to initiate and proactively engage their children in productive, critical discussions around race/racism and anti-racism. This study will recruit a national sample of parents and their K-2nd grade children. The impact of the intervention will be tested using a rigorous randomized wait-list controlled trial design. The design of the intervention is based on research indicating that among children, positive intergroup contact with outgroup members, including vicarious engagement, can prevent or reduce anti-outgroup bias, in particular, when contact is based on common goals, cooperation rather than competition, and supported by external authorities. To evaluate the effectiveness of the program, a mixed-methods design will be utilized involving collection of a broad range of outcome measures through online questionnaire surveys, one-on-one interviews with parents and children, and parent-child dyadic interviews. Read Less

The long-term goal is to develop effective parenting strategies to facilitate optimal child development for mothers suffering with PPD symptoms. The overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone. Findings from this application can be used to inform a future study to test the effectiveness and implementation of this social media-based parenting program. Read Less

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. Read Less

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). Read Less