[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-behavior\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-behavior":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100638128","fathers-involvement-in-infant-care-and-infants-development-100638128",false,"NCT07627126","Fathers' Involvement in Infant Care and Infants' Development","Fathers' Involvement in Infant Care and Infants' Sensory Processing","Inclusion Criteria:\n\n* Term infants (37-40 weeks),\n* Infants aged 4-6 months\n\nExclusion Criteria:\n\n* Preterm infants,\n* Infants with congenital infections or proven genetic changes,\n* Infants and mothers diagnosed with metabolic, neurological, and genetic diseases,\n* Children whose parents did not volunteer to study",true,"ALL","4 Months","6 Months",{"count":21,"type":22},75,"ESTIMATED","OBSERVATIONAL","In the early stages of life, newborns are dependent on caregivers to meet their basic needs for survival, feeding, and care. Generally, mothers assume primary responsibility for meeting their infants' basic needs and providing care, while fathers take on a supporting role. Both mothers and fathers actively contribute to the baby's healthy emotional development. This study, planned with fathers of 4-6 month old infants, addresses the lack of quantitative evidence regarding the relationship between fathers' involvement in infant care and infants' sensory processing.",[26,27],"Infant Behavior","Father - Child Relations",[29,30,31,32],"Infant","Sensory Processing","Father","Infant Care","RECRUITING","2026-05-30",{"date":36,"type":37},"2026-06-04","ACTUAL",{"date":34,"type":37},{"date":40,"type":22},"2027-03-15",{"name":42,"class":43},"Nigde Omer Halisdemir University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100552914","talk-with-me-baby-to-enhance-the-early-home-language-environment-100552914","NCT06479278","Talk With Me Baby to Enhance the Early Home Language Environment","Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment for Rural and Underserved Children","TWMB","Inclusion Criteria:\n\nFor this study, each child-caregiver dyad will consist of:\n\n1. A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and\n2. The child of the above caregiver for whom the WCC visits are conducted.\n\nA potential caregiver participant must meet all the following inclusion criteria to enroll in the study:\n\n1. Be the age of majority, or older, as defined by the state of residency.\n2. Able to complete study measures in English.\n3. Have the legal authority to consent to participate for themselves and to consent on behalf of their child.\n\nTo proceed to the follow-up portion of the study the caregiver (dyad) must have a LENA baseline assessment score that is ≤ 75th percentile compared to a child's age-referenced normative data.\n\nA potential child participant must meet all the following inclusion criteria to be enrolled in the study:\n\n1. Receive WCC at a participating clinic from a participating provider.\n2. Be zero to nine months (+ 0-30 days) old at enrollment.\n3. Was born at full term (\\> 37 weeks gestation).\n4. Was born in a singleton birth (i.e., was the only child delivered during the birth).","0 Months","9 Months",{"count":56,"type":22},66,"INTERVENTIONAL",[59],"NA","The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:\n\nWill the TWMB program increase the time a caregiver talks to their infant?\n\nParticipants will:\n\n1. Come to at least four well-child checkups\n2. Receive the TWMB program from the provider during the checkups\n3. Record their conversations with their infant before they receive the program and after they receive the program four times.",[62,63,64,26,65,66],"Language Development","Speech","Infant Development","Language, Child","Language","2025-08-27",{"date":69,"type":37},"2025-08-29",{"date":71,"type":37},"2025-02-03",{"date":73,"type":22},"2026-08-31",{"name":75,"class":76},"IDeA States Pediatric Clinical Trials Network","NETWORK",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":16,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":57,"phases":91,"briefSummary":92,"conditions":93,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":44},"100557963","improving-maternal-sleep-and-mental-health-100557963","NCT06544941","Improving Maternal Sleep and Mental Health","Improving Maternal Mental Health in Military-Affiliated Pregnant Women: Effectiveness of a Smart Bassinet","SHINE","Inclusion Criteria:\n\n* Pregnant women with a singleton gestation who have a military affiliation\n* Ages 18-45 years\n* Ability to communicate during the screening process\n* Access to a computer, smart phone or tablet with internet service\n* Willing to use bassinet they are randomized to\n* Willing to travel to a local Quest for blood draw\n\nExclusion Criteria:\n\n* Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section (SCID-I). Current active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence during the last 90 days. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded.\n* Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet.\n* Under the age of 18 years or \\> 45 years. The goal is to include women of childbearing age.\n* Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult.\n* Tobacco use (current). Smoking is associated with poor sleep and inflammation.\n* Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and\u002For obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment.\n* Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.","FEMALE","18 Years","45 Years",{"count":90,"type":22},342,[59],"The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent\u002Fmitigate postpartum mood disorders by augmenting maternal sleep and\u002For enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual\u002Ftraditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nAim 1: Determine the effect of the SB on infant sleep and maternal sleep. \\[primary hypothesis or outcome measure 2\\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU.\n\nMilitary-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.",[94,95,96,26,97,98,99],"Postpartum Depression","Postpartum Anxiety","Sleep Disturbance","Maternal Behavior","Inflammation","Military Family",[101,102,103,104,105,106],"sleep","postpartum","intervention","inflammation","depression","anxiety","2025-02-06",{"date":109,"type":37},"2025-02-10",{"date":111,"type":37},"2025-01-15",{"date":113,"type":22},"2028-06",{"name":115,"class":43},"University of Colorado, Colorado Springs"]