[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"developmental-delay\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:developmental-delay":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,53,84,121,151,201,235,266,298,330],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100625608","phase-2-xylitol-and-the-prevention-of-periodontal-disease-and-preterm-birth-trial-100625608",false,"NCT07424846","Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial","Xylitol and the Prevention of Periodontal Disease and Preterm Birth (XaPPP) Trial","XaPPP","Inclusion Criteria:\n\n* Able to provide informed consent. For those under 18 years of age, an approval will additionally be sought from the parent or guardian\n* Less than 20 weeks' gestation (by best obstetric estimate)\n* At least 20 natural teeth\n* Planning to deliver at one of the health facilities within the XaPPP trial\n* Receiving antenatal obstetric care at one of the 8 health districts\n* Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy\n* Willing to attend all study visits\n* Willing to provide biospecimens (oral, vaginal, placental, breast milk)\n* Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \\\u003C20 weeks of pregnancy, 28-30 weeks of pregnancy, and 6-8 weeks after giving birth\n* Willing to have their child undergo follow up through at least 12 months after birth including neurodevelopmental examination(s)\n* Speaks Chichewa or English\n\nAll patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.\n\nExclusion Criteria:\n\n* Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy\n* Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others)\n* Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy\n* Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta)\n* Known allergy to xylitol","FEMALE",{"count":19,"type":20},6000,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact of xylitol-containing chewing gum compared to no chewing gum on reducing the occurrence of maternal periodontal disease, preterm birth, and low birthweight offspring. The premise of this study centers upon the numerous publications supporting a strong association between maternal periodontal disease and preterm birth. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum.\n\nWhile PPaX demonstrated the efficacy of xylitol to reduce preterm birth (PTB), the study had important limitations: (a) PPaX was an unblinded cluster-randomized study with only 8 clusters, 4 with xylitol-containing chewing gum and 4 without any gum (not placebo-controlled); (b) PPaX used a suboptimal dose of 2 grams of xylitol daily which may have reduced the effectiveness of the intervention given that recent literature suggests 5-10 grams\u002Fday more effectively improve oral health; and (c) PPaX did not evaluate infant mortality nor early neurodevelopmental outcomes. Notably, reducing fetal exposure to periodontal disease (PD) as well as PTB may improve neurodevelopmental outcomes for offspring as both prematurity and fetal exposure to inflammation are well-documented risk factors for neurodevelopmental delay (NDD) and infant mortality.\n\nThe investigators will conduct a double-blind, placebo-controlled, individually randomized clinical trial with 3 arms among Malawian pregnant individuals (n=6000) at \\\u003C20 weeks of pregnancy with the co-primary outcomes being the incidence of PTB and low birthweight offspring. The 3 study arms (n=2000 each) will be (a) an optimized dose of xylitol-containing chewing gum (6.4 grams\u002Fday), (b) the PPaX trial xylitol dose (2.1 grams\u002Fday), or (c) flavored sorbitol gum base (placebo control). This trial overcomes the PPaX trial's limitations and will definitively answer whether xylitol prevents PTB in Malawi. The investigators will additionally collect biospecimens from a random sampling of the participants for biobanking for later analysis of inflammatory and microbiome alterations that may occur with xylitol exposure compared with placebo. The investigators hypothesize that pregnant individuals who chew xylitol-containing chewing gum will have a significant reduction in periodontal disease metrics at 28-30 weeks' gestation (e.g. bleeding on probing) as well as offspring with improved neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development 4th edition and reduced risk of adverse pregnancy outcomes including preterm birth.",[27,28,29,30,31],"Preterm Birth","Low Birthweight Neonate","Periodontitis","Gingivitis","Developmental Delay",[33,34,35,36,37,38,39],"xylitol","preterm birth","prematurity","pregnancy","periodontitis","periodontal disease","chewing gum","RECRUITING","2026-06-05",{"date":43,"type":44},"2026-06-09","ACTUAL",{"date":46,"type":44},"2026-03-26",{"date":48,"type":20},"2030-09-30",{"name":50,"class":51},"University of Washington","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":52},"100309359","mirror-neuron-network-dysfunction-as-an-early-biomarker-of-neurodevelopmental-disorder-100309359","NCT03307317","Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder","* INCLUSION CRITIERIA:\n\nHealthy adults\n\n* Age of 18-65 at study entry\n* Healthy and good condition as determined by medical history and physical examination\n\nHealthy Infants\n\n* 9 months +\u002F- 2 weeks of age at time of consent\n* Healthy and good condition as determined by medical history and physical examination\n* Age appropriate development as determined by parent report and exam\n* Full term at birth\n* Normal weight for gestational age\n\nAt Risk Infants\n\n* 12 months +\u002F- 2 weeks at the time of consent\n* Must have at least one of the following: observed developmental delay; sibling of a child with autism; premature birth; small for gestational age\n\nEXCLUSION CRITERIA:\n\nHealthy Adults\n\n* Uncorrected auditory impairment\n* Uncorrected visual impairment\n* Head injury with loss of consciousness\n* Inability to provide consent\n* Subject has a condition, that in the opinion of the investigator, creates an unacceptable risk for participation\n\nHealthy and At-Risk Infants\n\n* A language other than English as the primary language spoken at home\n* Having a medical impairment that interferes with study participation such as having a g-tube, shunt or seizure disorder and inability to hold one s head upright\n* Having a known visual impairment\n* Having a known auditory impairment",true,"ALL","9 Months","65 Years",{"count":64,"type":20},200,"OBSERVATIONAL","Background:\n\nPeople show changes in brain activity when they watch other people do actions. This may be part of early social and communication skills. Researchers want to understand the stages of normal development of motor observation and imitation in people and how it relates to social development in infants and toddlers.\n\nObjective:\n\nTo study the nature of brain activity that underlies typical brain functioning in infants, toddlers, and adults.\n\nEligibility:\n\nInfants ages 8 12 months\n\nHealthy adults ages 18 65\n\nDesign:\n\nAdult participants will have one visit. They will:\n\nAnswer questions about their family, like its size and ethnicity.\n\nAnswer questions about their own behavior and do a simple motor task.\n\nHave EEG\u002FfNIRS. A damp elastic cap with small sensors will be placed on the head. Participants will observe stimuli, either on a video screen or of a live person. The sensors will be connected to a computer. That will record the participant s brain activity while watching pictures on a screen.\n\nInfant participants will have 2 visits.\n\nTheir parents will answer questions about their family.\n\nThe parents will fill out forms about their child s development. These will be mailed to them before each visit.\n\nParents will stay with their infant while study staff does an assessment of the child s communication, motor, and thinking skills.\n\nInfants will have EEG\u002FfNIRS.\n\nInfants who are at risk for developmental delays will come back for another visit when they are about 2 years old. This will repeat the infant visits but it will not include EEG\u002FfNIRS.\n\nSome questionnaires and assessments will be videotaped.",[31],[69,70,71,72,73],"Near Infrared Spectroscopy","EEG","Functional Brain Activity","Neurodevelopment","Natural History","2026-05-28",{"date":76,"type":44},"2026-05-29",{"date":78,"type":44},"2018-08-30",{"date":80,"type":20},"2031-02-01",{"name":82,"class":83},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":59,"sex":60,"minAge":4,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":52},"100633246","a-self-instructional-online-program-for-early-childhood-and-elementary-teachers-supporting-autistic-children-and-children-with-developmental-delays-100633246","NCT07524192","A Self-Instructional Online Program for Early Childhood and Elementary Teachers Supporting Autistic Children and Children With Developmental Delays","Development and Preliminary Evaluation of a Self-Instructional Online Program for Early Childhood and Elementary Teachers Supporting Autistic Children and Children With Developmental Delays","SEED","Inclusion Criteria:\n\n* Public school teachers currently employed in kindergarten or elementary schools who hold at least a Level 2 teaching certificate (or higher).\n* Teachers who understand the purpose of the study and provide informed consent to participate.\n\nExclusion Criteria:\n\n* Teachers who have majored in special education at the undergraduate or graduate level.",{"count":93,"type":20},70,[95],"NA","The goal of this clinical trial is to evaluate the preliminary effectiveness and acceptability of a self-instructional, web-based teacher training program designed to support the development of autistic children and children with developmental delays.\n\nThis study aims to examine whether participation in the program can improve teachers' knowledge, attitudes, and teaching self-efficacy related to inclusive education and support for autistic children and children with developmental delays.\n\nThe main questions it aims to answer are:\n\n1. Does participation in the self-instructional program improve teachers' knowledge about autism and developmental delays?\n2. Does the program improve teachers' attitudes toward inclusive education and their teaching self-efficacy? Researchers will compare teachers who participate in the self-instructional online intervention program (SEED program) with teachers who receive comparison educational materials (Kit for Kids from Organization for Autism Research) to determine whether the intervention leads to greater improvements in knowledge, attitudes, and teaching self-efficacy.\n\nParticipants will:\n\n1. Complete an online pre-intervention survey assessing background information, knowledge, attitudes toward inclusion and neurodiversity, and teaching self-efficacy.\n2. Participate in a two-week self-instructional online program or receive comparison materials, depending on group assignment\n3. Complete an online post-intervention survey evaluating the same outcomes, as well as program satisfaction and acceptability.",[98,99,31,100,101],"Autism Spectrum Disorder","Developmental Disabilities","Teacher Training","Inclusive Education",[98,103,104,100,105,106,107,108,109,110,111],"Developmental delay","Developmental disabilities","Inclusive education","Kindergarten Teachers","Elemantary School Teachers","General Education Teachers","Special Education Support","Web-Based Intervention","Self-Instructional Learning","2026-04-06",{"date":114,"type":44},"2026-04-13",{"date":116,"type":44},"2026-02-05",{"date":118,"type":20},"2026-12-31",{"name":120,"class":51},"Boin Choi",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":59,"sex":60,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":52},"100575361","problem-behavior-assessment-and-intervention-in-idea-part-c-services-100575361","NCT06771284","Problem Behavior Assessment and Intervention in IDEA Part C Services","Problem Behavior Assessment and Intervention in IDEA Part C Services: A Single-Case Study","Child Inclusion Criteria:\n\n* age birth to 5 years old\n* has a developmental disability or delay based on caregiver report and\u002For receiving early intervention services\n* has problem behavior, as reported by the caregiver and\u002For early intervention professional\n\nCaregivers (e.g., parent, grandparent) of eligible child participants will participate with their child as the implementer of all procedures.\n\nAn early intervention professional will participate with each caregiver-child dyad to coach the caregiver, in addition to the researcher.","0 Months","5 Years",{"count":131,"type":20},9,[95],"The purpose of this study is to evaluate the effect of function-based assessment and intervention to reduce problem behavior in children with developmental disability or delay in the context of IDEA Part C services. The investigators will conduct a single-case study to evaluate the efficacy of the intervention.",[135,31,136],"Problem Behavior","Developmental Disability",[138,139,140,141],"Early childhood","Problem behavior","Home-based services","IDEA Part C services","2026-01-20",{"date":144,"type":44},"2026-01-22",{"date":146,"type":44},"2025-09-30",{"date":148,"type":20},"2027-05",{"name":150,"class":51},"University of Nevada, Las Vegas",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":60,"minAge":4,"maxAge":4,"enrollmentInfo":158,"targetDuration":129,"studyType":65,"phases":4,"briefSummary":160,"conditions":161,"keywords":167,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":52},"100323523","longitudinal-study-of-neurogenetic-disorders-100323523","NCT03492060","Longitudinal Study of Neurogenetic Disorders","Neurogenetic Disorders: A Longitudinal Study on Natural History and Intervention Strategies","Inclusion Criteria:\n\n* Individuals must have had whole genome\u002Fexome sequencing and have a confirmed variant in any gene.\n\nExclusion Criteria:\n\n* Subjects who cannot provide genetic confirmation of a predicted deleterious variant in any gene.",{"count":159,"type":20},1000,"The purpose of this study is to analyze patterns in individuals with hnRNP (and other) genetic variants, including their neurological comorbidities, other medical problems and any treatment. The investigators will maintain an ongoing database of medical data that is otherwise being collected for routine medical care. The investigators will also collect data prospectively in the form of questionnaires, neuropsychological assessments, motor assessments, and electroencephalography to examine the landscape of deleterious variants in these genes.",[162,163,31,98,164,165,166],"Neurodevelopmental Disorders","Intellectual Disability","Seizures","Hypertonia, Muscle","Hypotonia",[168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191],"Gene Variant","HNRNPA1","HNRNPA2","HNRNPB1","HNRNPC1","HNRNPC2","HNRNPD","HNRNPE1","HNRNPE2","HNRNPE3","HNRNPE4","HNRNPG","HNRNPH1","HNRNPH2","HNRNPI","HNRNPK","HNRNPL","HNRNPM","HNRNPP","HNRNPQ1","HNRNPQ2","HNRNPQ3","HNRNPR","HNRNPU","2025-10-24",{"date":194,"type":44},"2025-10-27",{"date":196,"type":44},"2018-06-13",{"date":198,"type":20},"2030-12",{"name":200,"class":51},"Columbia University",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":60,"minAge":208,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":219,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100475177","pact-programme-for-parents-of-children-with-shcn-100475177","NCT05467527","PACT Programme for Parents of Children With SHCN","Effectiveness of Prosocial-orientated Acceptance and Commitment Training (PACT) Programme for Parents of Children With Special Health Care Needs in Response to Outbreaks of Novel Infectious Disease: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Cantonese-speaking Hong Kong residents\n* Living together with the child who is at preschool\u002Fschool-age (3-8 years old)\n* Caregivers who adopted the responsibility of taking care of the child,\n* has daily access to their iPhone and Android smartphones.\n\nIn addition, potential eligible parents who respond \"yes\" to any of the five validated screening questions in the Children with Special Health Care Needs (SHCN) Screener (see https:\u002F\u002Fwww.childhealthdata.org\u002Fdocs\u002Fcshcn\u002Ftechnical-summary-of-cshcn-screener.pdf) will then be asked the associated follow-up questions to determine whether the child possesses physical, neurodevelopmental\u002Femotional problem(s) that has lasted for at least 12 months. Only children with a positive response(s) to ≥ 1 item in each of the associated follow-up questions will be classified as children with SHCN.\n\nExclusion Criteria:\n\n* Parents who have diagnoses of severe mental illness or developmental disabilities, such as intellectual disabilities","21 Years",{"count":210,"type":20},196,[95],"This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.",[214,215,216,217,162,218,98,31],"Urologic Diseases","Gastrointestinal Diseases","Vascular Diseases","Cleft Lip and Palate","Attention Deficit Hyperactivity Disorder",[220,221,222,223,224],"Acceptance and Commitment Therapy","Randomised Controlled Trial","Special health care needs","novel infectious disease","prosociality","2025-08-08",{"date":227,"type":44},"2025-08-13",{"date":229,"type":44},"2022-06-27",{"date":231,"type":20},"2025-12-31",{"name":233,"class":51},"Chinese University of Hong Kong",2,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":59,"sex":60,"minAge":242,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":52},"100597169","investigation-of-the-effects-of-basic-body-awareness-training-on-motor-skills-n-children-at-risk-of-developmental-delay-100597169","NCT07054996","Investigation of the Effects of Basic Body Awareness Training on Motor Skills İn Children at Risk of Developmental Delay","Investigation of the Effects of Basic Body Awareness Training on Motor Skills, Play Skills, and Social Participation in Children at Risk of Developmental Delay","Inclusion Criteria:\n\n* Children aged 4 to 6 years attending preschool\n* Those who voluntarily agreed to participate in the study\n\nExclusion Criteria:\n\n* Children with neurological problems\n* Children who are uncooperative\n* Children receiving speech and language therapy","4 Years","6 Years",{"count":245,"type":20},72,[95],"The aim of this study is to investigate the effects of basic body awareness training on preschool children with developmental delays.",[31,249],"Body Perception",[251,252,253,254,255],"basic body awareness therapy","Motor development","Body perception","Mental rotation","developmental delay","NOT_YET_RECRUITING","2025-07-03",{"date":259,"type":44},"2025-07-08",{"date":261,"type":20},"2025-07",{"date":263,"type":20},"2025-12",{"name":265,"class":51},"Harran University",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":59,"sex":60,"minAge":4,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":21,"phases":277,"briefSummary":278,"conditions":279,"keywords":280,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":297},"100548643","improving-neurodevelopmental-outcomes-after-prenatal-cannabinoid-in-utero-exposure-100548643","NCT06423664","Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure","Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)","INTACT","Inclusion Criteria:\n\nBirthing Parent\n\n* Age of majority, as defined by the state of residency\n* Cannabinoid use during pregnancy confirmed with self-report\n* Have the ability to speak, read, and understand English\n* Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records\n* Has parental custody of the infant\n* Singleton pregnancy with live birth\n* Has an electronic device capable of watching videos and able to stream\u002Fdownload videos for viewing and permitting video conferencing\n* Has study access to the internet\n\nInfant\n\n* Term infants at birth (\\>37 weeks' gestation)\n* Biological child of the birthing parent\n\nExclusion Criteria:\n\nBirthing Parent\n\n* Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results\n* Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy\n* Prolonged hospitalization following delivery longer than 7 days\n\nInfant\n\n* Has major birth defect(s) including physical anomalies including limb malformations\u002Fabsence of limbs or chromosomal abnormalities\n* Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization\n* Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)","7 Days",{"count":276,"type":20},20,[95],"The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent\u002Finfant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation.",[31],[281,282,283,284,285,286],"Behavioral health intervention","Prenatal substance exposure","Neurodevelopmental outcomes","Pediatric intervention","Developmental disorders","Pediatric health","2025-06-23",{"date":289,"type":44},"2025-06-24",{"date":291,"type":44},"2025-02-06",{"date":293,"type":20},"2026-08-31",{"name":295,"class":296},"IDeA States Pediatric Clinical Trials Network","NETWORK",3,{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":60,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":21,"phases":310,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":52},"100425129","early-detection-and-intervention-in-developmental-delay--behavioral-problems-in-preschool-children---pluss-100425129","NCT04815889","Early Detection and Intervention in Developmental Delay \u002F Behavioral Problems in Preschool Children - PLUSS","The PLUSS Model: a Study Protocol for Evaluation of a Multi-professional and Intersectoral Working Model to Detect Neurodevelopmental Difficulties in Preschool Children as Well as to Provide Parental Support","PLUSS","Inclusion Criteria:\n\n* Development Delay\n* Interaction, contact difficulties\n* Language and communication difficulties\n* Difficulties in everyday function\n* Motor difficulties\n* Concentration \u002F hyperactive\n* Self-regulation\n* Acting \u002F boundaries\n* Anxiety\n* No claim to diagnosis\n\nExclusion Criteria:\n\n* Not only support in the parent role, without any of the problems above.","18 Months","72 Months",{"count":309,"type":20},600,[95],"The PLUSS (Mental health, learning, development, collaboration around preschool children) is a collaborative project involving guardians, Jönköping County´s health care, preschools and social services. The project studies the implementation of a \"One way in\"-model that provides coordinated services to screen, evaluate and treat toddlers with behavioral problems. The project also provides parental interventions and education for preschool teachers.\n\nThe study aims to investigate a) implementation of the PLUSS model, b) effectiveness of the model and the included parental training program on behavioral problem and their longitudinal development among preschool children, c) parental wellbeing and satisfaction. In the long term, the goal is to reduce mental health problems among children, adolescents and their families and to provide support for a functioning everyday life.",[31,313,314],"Behavioural Problem","Neurodevelopmental Delay",[316,31,317,318,319],"Behavioural problems","Intervention","Preschool children","Screening","2025-05-15",{"date":322,"type":44},"2025-05-21",{"date":324,"type":44},"2019-08-01",{"date":326,"type":20},"2027-12-31",{"name":328,"class":329},"Region Jönköping County","OTHER_GOV",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":59,"sex":60,"minAge":337,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":341,"conditions":342,"keywords":347,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":52},"100479753","development-of-motility-and-cognition-in-infants-100479753","NCT05527080","Development of Motility and Cognition in Infants","PILKE","Inclusion Criteria:\n\n* age at enrollment 5-8mos\n* typically developing\n\nExclusion Criteria:\n\n* all neurologically significant medical histories during pregnancy, at birth or postnatally\n* suspicion of developmental delay\n* suspicion or diagnosis of syndromes with neuromotor symptoms","5 Months","26 Months",{"count":340,"type":20},250,"PILKE study uses wearables for assessing motor development in infants in order to define functional growth trajectories in the normal infants and infants at risk of neurological compromise. In addition, PILKE studies correlation of early motor development to later neurocognitive development.",[162,31,343,344,345,346],"Development, Infant","Child Development","Cognitive Developmental Delay","Neurophysiologic Abnormality",[348,349,350,351,352],"wearable","medical wearable","human activity recognition","growth chart","neurodevelopment","2025-03-30",{"date":355,"type":44},"2025-04-03",{"date":357,"type":44},"2021-10-01",{"date":359,"type":20},"2027-12-30",{"name":361,"class":51},"Helsinki University Central Hospital"]