[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Homerton University Hospital NHS Foundation Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100517857","fathers-and-partners-in-family-integrated-care-study-100517857",false,"NCT06022991","Fathers and Partners in Family Integrated Care Study","TARGET Study: faThers And paRtners in Family inteGrated carE sTudy- A Prospective Multicentre Multiphase Study Investigating Father\u002FPartner Involvement in Family Integrated Care in Neonatal Units","TARGET","Parents of preterm infants will be recruited to the study.\n\nInclusion criteria:\n\n1. Parents of 22+0 to 32+6 weeks preterm infants.\n2. Infant from day one to 7 days of age.\n3. Infant should have two primary caregivers. Father's\u002FPartner's participation in the study is a must and participation from both parents is ideal.\n4. The parents should have conversational English.\n\nExclusion criteria:\n\n1. Infant with life-limiting condition or no realistic chance of survival.\n2. Infant is likely to be transferred to non-participating centre within 4 weeks of age.\n3. Parents under the age of 16 years.","ALL",{"count":19,"type":20},40,"ESTIMATED","OBSERVATIONAL","AIMS: The primary aim is to investigate the impact of enhancing father\u002Fpartner engagement in FICare of preterm infants on their mental health (MH) up to 6 weeks post discharge. Secondary aims are to investigate the impact on maternal MH.\n\nMETHOD and ANALYSIS: This is a two-phase study: Phase-1 to gather baseline information and Phase-2 to assess the impact of improved father\u002Fpartner engagement in FICare involving two NUs (a tertiary and level 2). 20 families of infants born at \\\u003C33 weeks will be studied in each phase (40 fathers, 40 mothers, 40 babies).\n\nFather\u002Fpartner MH will be assessed using validated questionnaires: Generalised Anxiety Disorder Assessment (GAD-7), Patient Health Questionnaire (PHQ-9), Parental Stressor Scale: NICU (PSS:NICU), and by semi-structured qualitative interviews. Similarly, mothers will be assessed by the same questionnaires and focus groups.\n\nThe Neonatal DadPad materials will be updated using information from phase 1 study, systematic review of Fathers experiences of FICare and advice from parent advisory group. Father's engagement in FICare will be enhanced using Neonatal DadPad information booklet and app, father-specific peer support and bitesize teaching on caring for NU babies (Phase 2).\n\nThematic analysis of the qualitative data will be performed. Phase 1 and Phase 2 study findings will be compared by performing appropriate statistical analysis.",[24,25],"Mental Health Wellness 1","Premature Birth",[27,28,29,30,31],"Father\u002Fpartner wellbeing","Maternal wellbeing","Paternal infant engagement","NICU","Family integrated care (FICare)","RECRUITING","2023-09-01",{"date":35,"type":36},"2023-09-05","ACTUAL",{"date":38,"type":36},"2022-11-01",{"date":40,"type":20},"2026-10-30",{"name":42,"class":43},"Homerton University Hospital NHS Foundation Trust","OTHER",2,""]