[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634594":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":52,"collaborators":55,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":18,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":18,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Universiteit Antwerpen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","EXPERIMENTAL","Participants assigned to this condition will receive the six-week intervention program. They complete questionnaires during the 12-month study period.",[13],"Behavioral: Structured early parenting support program, called \"Eat, sleep, cry - repeat\"",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","NO_INTERVENTION","Participants assigned to this arm complete the same questionnaires during the 12-month study period but do not receive the intervention.\n\nParticipants assigned to this arm complete the same questionnaires during the 12-month study period but do not receive the structured parenting intervention. Participants receive care as usual, consisting of standard preventive child health care provided by routine services (e.g., monitoring of growth, development, and vaccinations). Additional support may be provided if concerns arise, but no structured intervention targeting regulatory problems is systematically offered.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Structured early parenting support program, called \"Eat, sleep, cry - repeat\"","The program includes one individual session with a trained psycho-educator, five group sessions (two in person, three online), and access to a digital support tool via a mobile application. Sessions provide psycho-education, discussion, reflection, and peer support. The modules in the app address early regulatory difficulties such as excessive crying, feeding, or sleep problems, as well as other themes such as social support and the partner relationship. In the group sessions, the psycho-educators will refer to and expand on the app materials, allowing for deeper discussion and personalization of the content in line with the needs and questions of participating families.",[9],[26],{"name":27,"affiliation":5,"role":28},"Edwin Wouters, Prof. Dr.","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Fien Plochaet","CONTACT","+3232652016","fien.plochaet@uantwerpen.be",{"name":36,"role":32,"phone":18,"phoneExt":18,"email":37},"Sara De Bruyn","sara.debruyn@uantwerpen.be",[39],{"facility":40,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":18},"University of Antwerp","RECRUITING","Antwerp","2000","Belgium","BE",{"type":47,"coordinates":48},"Point",[49,50],4.40026,51.22047,{"lat":50,"lon":49},{"type":28,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Edwin Wouters","Prof. Dr. Edwin Wouters",[56,58],{"name":57,"class":6},"KU Leuven",{"name":59,"class":60},"Opgroeien","UNKNOWN","100634594","developing-and-testing-a-preventive-primary-care-parenting-intervention-to-strengthen-parent-infant-co-regulation-in-families-experiencing-early-regulatory-difficulties-100634594",false,"NCT07541716","Developing and Testing a Preventive Primary Care Parenting Intervention to Strengthen Parent-Infant Co-Regulation in Families Experiencing Early Regulatory Difficulties","Inclusion Criteria:\n\n* Parent (or primary caregiver) of an infant aged approximately 3 months at enrollment.\n* Aged 18 years or older.\n* One parent has completed the brief screening questionnaire and scored above a predefined cutoff indicating elevated levels of infant regulatory problems and eligibility for the intervention.\n\nExclusion Criteria:\n\n* Insufficient proficiency in Dutch to understand study materials or participate in intervention sessions\n* No access to the internet or a compatible device required to use the mobile application","ALL","18 Years",{"count":70,"type":71},200,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this randomized controlled trial is to evaluate the effectiveness of a structured parenting support program for families with young infants experiencing early regulatory difficulties. Participants are families with infants approximately 3 months of age who score above a predefined threshold on a screening questionnaire assessing early regulatory problems.\n\nThe main questions this study aims to answer are:\n\n* Does participation in the parenting support program reduce parental stress and improve parental self-efficacy from baseline to post-intervention?\n* Does the intervention reduce infant regulatory problems (e.g., excessive crying, feeding difficulties, and sleep problems) at 6-month follow-up (i.e., when the child is approximately 12 months old)?\n\nResearchers will compare families receiving the structured parenting support program to families receiving usual care to evaluate the effects of the intervention.\n\nParticipants will complete questionnaires when the infant is approximately 3-4 months old (baseline), around 6 months of age (post-intervention), and follow-up assessments will be conducted when the child is approximately 9 and 12 months old.\n\nIf assigned to the intervention group, participants will attend one individual session and five group sessions led by trained psycho-educators and receive access to psycho-educational content through a mobile application.",[77,78,79,80],"Infant Regulatory Problems","Regulatory Problems in Infancy","Parental Stress","Parental Self-efficacy",[82,83,84,85,86,87,88,89,90,91,92,93,94,95],"Early infancy","Infant regulatory problems","Parental well-being","Parenting support","Behavioral intervention","Family intervention","Parent-infant relationship","Randomized controlled trial","Psychoeducation","Regulatory problems in infancy","Infant mental health","Parent-infant mental health","Parental stress","Parental self-efficacy","2026-06-05",{"date":98,"type":99},"2026-06-09","ACTUAL",{"date":101,"type":99},"2026-05-06",{"date":103,"type":71},"2027-07",{"name":5,"class":6},1]