[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-problem\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-problem":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100628470","talk-parenting-education-program-ii-100628470",false,"NCT07462052","Talk Parenting Education Program II","Utilizing Smart Speaker Technology to Deliver Parenting Education Support to Parents of Young Children","TP2","Inclusion Criteria:\n\n* Referred by a participating agency\n* Child 3-5 years old who lives with the parent at least half time\n* The primary parent in the home (typically the mother but not always)\n* Speaks English\n* Has access to a computer, tablet, or mobile phone at home\n* Access to high-speed internet at home is desired but not required.\n\nThe project will cover internet costs for a small number of participants if needed. The participating agencies all serve families who are low-income and\u002For experiencing economic hardship, stressful family relationships, children's behavior problems, or household instability; thus referred families will be experiencing one or more of these risk factors for an at-risk family environment.\n\nExclusion Criteria:\n\n* Families of target-age children with a developmental disability severe enough that the child cannot speak or follow simple directions will be excluded\n* Families of target-age children whose needs are beyond the scope of Talk Parenting will be excluded",true,"ALL","3 Years","90 Years",{"count":22,"type":23},184,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this clinical trial is to learn whether Talk Parenting, a voice-based program delivered through an Amazon Echo Dot (Alexa), can help parents and caregivers of children ages 3-5 years improve challenging bedtime and morning routines. The main questions it aims to answer are:\n\nDoes using Talk Parenting improve families' bedtime and morning experiences and children's sleep\u002Fwake habits?\n\nDoes using Talk Parenting improve parents' routine-related parenting practices and confidence, strengthen the parent-child relationship, and reduce children's behavior problems and parents' stress?\n\nResearchers will compare families who receive Talk Parenting right away to families who wait 6 weeks to receive the program (a waitlist control group receiving usual services during the wait).\n\nParticipants will:\n\nComplete online questionnaires at the start of the study and again about 6 weeks later (and a follow-up questionnaire later in the study).\n\nReceive a pre-configured Amazon Echo Dot (to keep) and instructions to use Talk Parenting routines at home, including a bedtime routine, a brief calming routine, and a morning routine (enabled after the first 2 weeks).",[29,30,31,32,33,34,35],"Parenting Practices","Self Efficacy","Stress","Child Behavior","Emotional Adjustment","Sleep Problem","Parent-Child Relations",[37,38,39,40],"Feasibility","Satisfaction","Usability","Efficacy","NOT_YET_RECRUITING","2026-03-06",{"date":44,"type":45},"2026-03-10","ACTUAL",{"date":47,"type":23},"2026-07-01",{"date":49,"type":23},"2028-04-01",{"name":51,"class":52},"Oregon Research Behavioral Intervention Strategies, Inc.","INDUSTRY",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":17,"sex":18,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":24,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":5},"100546572","napbiome-targeting-gut-microbiota-and-sleep-rhythm-to-improve-developmental-and-behavioral-outcomes-in-early-childhood-100546572","NCT06396689","NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood","NapBiome","Inclusion Criteria:\n\nPreterm-arm:\n\n* neonates born between a gestational age of 34 0\u002F7 to 36 6\u002F7 weeks\n* partially breast-fed at the time of inclusion\n\nTerm-arm\n\n* neonates born at a gestational age of ≥ 37 0\u002F7 weeks Infants need to be\n* partially breast-fed at the time of inclusion\n\nExclusion Criteria:\n\nInfants who\n\n* receive probiotics outside the trial design\n* have a birth weight \\\u003C 1500 g\n* were prenatally drug-exposed (cannabis, cocaine, heroin, opiates, and alcohol)\n* have suspected or confirmed immunodeficiency\n* have an underlying disease (excluding transient conditions such as alimentation problems, hyperbilirubinemia, hypoglycaemia, anemia, respiratory distress syndrome or apnea-bradycardia syndrome), congenital malformations, central nervous system disease or injury or congenital infections","0 Days","7 Days",{"count":64,"type":23},380,[26],"The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important milestones in establishing sleep rhythm and neurodevelopment. Growing evidence suggests that the gut microbiome influences sleep, cognition, and early neurodevelopment. For term and preterm-born infants, difficulties in sleep regulation can have major consequences on infants' health, attachment between infants and their caregivers, and can even lead to life-threatening consequences such as shaken-baby syndrome. Preterm born infants are at even higher risk for sleep and neurodevelopmental problems. Although neonatal care has improved over recent decades, preterm birth rates continue to rise and lead to a wide range of neurodevelopmental disabilities that are unaddressed with current therapies. Given the importance of sleep and the gut microbiome for brain maturation, neurodevelopment, and behavior, identifying effective interventions within the gut-brain axis at the beginning of life is likely to have long-term implications for health and development of at-risk infants.\n\nThe aims of this project are to I) demonstrate the association between the gut microbiome, sleep patterns and health outcomes in children up to two years of age; and II) to leverage gut microbiome-brain-sleep interactions to develop new intervention strategies for at-risk infants. The investigators hypothesize that the establishment of a healthy gut microbiome during early life is crucial for both short- and long-term child health outcomes, as dysbiosis can harm sleep regulation, brain maturation, and neurobehavioral development. The investigators predict that the administration of synbiotics improves microbiota establishment, sleep rhythm, and neurodevelopmental outcomes.\n\nThis project integrates a randomized controlled trial (RCT), ex vivo, and in silico experiments with I) key technology platforms for computational modeling to capture the ontogenic norms of gut microbiota; II) neuronal and actimetry-based quantification of multidimensional aspects of infant sleep; III) breath metabolomics (exhalomics) of host and microbiome metabolism; and IV) high-throughput ex vivo models for investigating host-microbiome interactions. Outcomes include I) an understanding of age-normative microbiome composition, its variation (circadian, inter-individual), and the factors that influence the microbiome's plasticity throughout infancy; II) actionable knowledge of microbial species and metabolism that can be targeted to modify sleep regulation and improve neurodevelopmental outcomes, especially in at-risk infants (e.g., preterm-born); III) microbial and metabolic biomarkers with diagnostic potential for later regulatory and behavioral problems; and IV) an open-source analytical \"toolbox\" for microbial multi-omics that can be immediately applied in other areas of microbiome-host research. To achieve these goals, our strategy combines multiple disciplines focusing on factors that exert the greatest influence on health during infancy: the gut microbiome, sleep regulation, and neurodevelopment.\n\nThe impact of this project is substantial and globally relevant, as it advances possible treatment options for supporting neurodevelopmental health in preterm- and term-born infants, explores novel translational approaches for addressing regulatory difficulties, and provides key information for tailored prophylactic synbiotics and possible development of \"post-biotics\". Further, the study supports the investigation of biomarkers for neurodevelopment and advances early prevention of developmental and mental illnesses.",[34,68],"Neurobehavioral Manifestations",[70,71,72,73,74,75,76,77,78,79],"microbiome","infant","gut","metagenomics","development","metabolics","pre-term","probiotics","synbiotics","brain-gut","2025-02-17",{"date":82,"type":45},"2025-02-20",{"date":84,"type":23},"2025-03-01",{"date":86,"type":23},"2029-02-28",{"name":88,"class":89},"Petra Zimmermann","OTHER"]