[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552710":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":68,"studyPopulation":58,"armGroups":69,"interventions":80,"overallOfficials":85,"centralContacts":89,"locations":95,"responsibleParty":116,"collaborators":58,"id":119,"slug":58,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":58,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":126,"minAge":127,"maxAge":58,"enrollmentInfo":128,"targetDuration":58,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":146,"whyStopped":58,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"University of Haifa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":58},[9,13],{"measure":10,"description":11,"timeFrame":12},"Maternal Reflective Functioning questionnaires","Will be measured using Parental Reflective Function questionnaires for pregnancy P-PRFQ (Pajulo et al., 2015) and after birth (Parental Reflective Functioning Questionnaire PRFQ, Luyten et al., 2017). Likert Scale from 1 (Greatly disagree) to 7 (Greatly agree).","Twice in third trimester of pregnancy (Before and after intervention), 1 and 3 months after birth.",{"measure":14,"description":15,"timeFrame":16},"Maternal Reflective Functioning interviews","Will be measured using Pregnancy Interview (PI, Slade et al., 1987; Slade, 2003) before labor, and Parental Developmental Interview (PDI-R2 short form, Slade et al., 2003) after labor. Reflective Function Coding Scale- from -1 (No Reflective Function) to 9 (Very high Reflective Function)","Once in third trimester of pregnancy ,1 months after birth.",[18,22,25,29,32,35,38,42,45,48,52,55],{"measure":19,"description":20,"timeFrame":21},"Depression.","depression level before, during and after pregnancy and birth, using Edinburgh Postnatal Depression Scale (EPDS, Cox, Holden, \\& Sagovsky, 1987). Likert Scale from 1 (Most of the time) to 4 (Almost never).","Third trimester of pregnancy, 1 and 3 months after birth.",{"measure":23,"description":24,"timeFrame":21},"Anxiety","Anxiety level before, during and after pregnancy and birth using Depression Anxiety Stress Scale (DASS-21 short form, Lovibond \\& Lovibond, 1995 ). Likert Scale from 0- Does not describe my situation at all, to 3- Describes my situation very much.",{"measure":26,"description":27,"timeFrame":28},"Exposure to traumatic life events","exposure to ongoing war and political violence in the region using Political Life Events (PLE; Based on Slone et al., 1997, elaborated and adjusted by Yael Meir \\& Yael Enav, 2024, not published). Yes\u002FNo question and if Yes answered- Likert Scale from 1- Not at all to 5- Very much.","At enrollment.",{"measure":30,"description":31,"timeFrame":21},"Social Support","Social support before and during pregnancy using Multidimensional Scale of Perceived Social Support (MSPSS, Zimet et al., 1988). Likert Scale from 1- Very agree, to 7- Very disagree.",{"measure":33,"description":34,"timeFrame":21},"Relationship satisfaction","Relationship satisfaction before and during pregnancy using Couple satisfaction index (CSI-16, Funk \\& Rogge, 2007). Likert Scale from 0- Not true at all, to 5- Very true.",{"measure":36,"description":37,"timeFrame":28},"High risk pregnancy","Medical high risk during pregnancy using a single question in initial demographic and personal details questionnaire.",{"measure":39,"description":40,"timeFrame":41},"Cognitive bias","Cognitive bias before, during and after pregnancy and birth using an go-no-go, infants expression interpretation, and focus of attention assignments.","Third trimester of pregnancy, 3 months after birth.",{"measure":43,"description":44,"timeFrame":21},"Mother-infant bonding","Mother-infant bonding before birth using Prenatal Attachment Inventory (PAI: Muller \\& Mercer, 1993) after birth using Postpartum Bonding Questionnaire (PBQ, Brockington et al, 2006 ). PAI Likert Scale from 1- Almost never, to 4- Almost always.",{"measure":46,"description":47,"timeFrame":21},"Mother Emotional Regulation","Measured using Emotional Regulation Questionnaire (ERQ, Gross \\& John, 2003). Likert Scale from 1- Strongly disagree to 7- Strongly agree. PBQ Likert Scale from 1- Never to 6- Always",{"measure":49,"description":50,"timeFrame":51},"Infant weight","Gain of weight using a single question regarding infant's weight.","1 and 3 months after birth.",{"measure":53,"description":54,"timeFrame":51},"Maternal self-efficacy","Measured using Maternal self-efficacy Scale (Kestler-Peleg et al., 2015). Likert Scale from 1- Not at all, to 4- Very much.",{"measure":56,"description":57,"timeFrame":51},"Quality of sleep","Quality of sleep using Brief Infant Sleep Questionnaire (BISQ; Sade, 2004). Likert Scale from 1- Not at all to 4- Usually.",null,{"allocation":60,"interventionModel":61,"interventionModelDescription":58,"primaryPurpose":62,"observationalModel":58,"timePerspective":58,"maskingInfo":63},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":64,"maskingDescription":58,"whoMasked":65},"DOUBLE",[66,67],"PARTICIPANT","OUTCOMES_ASSESSOR","Using this trial, the investigators will be able to better understand rather MRF moderate the connection between risk factors to outcomes after birth related to both the mother and the infant. Using RCT design we will be able to understand mechanism of change.",[70,76],{"label":71,"type":72,"description":73,"interventionNames":74},"Maternal Reflective Functioning intervention group","EXPERIMENTAL","Will participate in a 4 session online psycho-educational workshop during pregnancy and after birth, focused on MRF.",[75],"Other: Maternal Reflective Function Workshop",{"label":77,"type":78,"description":79,"interventionNames":58},"Wiat-list control group","NO_INTERVENTION","group will undergo same measurements points with no intervention",[81],{"type":6,"name":82,"description":83,"armGroupLabels":84,"otherNames":58},"Maternal Reflective Function Workshop","4 session group online intervention focused on psycho-educational knowledge regarding emotional regulation and specifically MRF. group size- up to 15 participants. 2 sessions will be during pregnancy and 2 sessions will taken place 1 and 3 months after birth.",[71],[86],{"name":87,"affiliation":5,"role":88},"Yael Enav, Phd","PRINCIPAL_INVESTIGATOR",[90],{"name":91,"role":92,"phone":93,"phoneExt":58,"email":94},"Lee Barel Refaeli, PhD student","CONTACT","972-504084447","LEEBAREL@GMAIL.COM",[96],{"facility":5,"status":58,"city":97,"state":58,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Haifa","3103301","Israel","IL",{"type":102,"coordinates":103},"Point",[104,105],34.99928,32.81303,{"lat":105,"lon":104},[108,109,112,114],{"name":91,"role":92,"phone":93,"phoneExt":58,"email":94},{"name":110,"role":92,"phone":111,"phoneExt":58,"email":94},"Barel Refaeli","0504084447",{"name":91,"role":113,"phone":58,"phoneExt":58,"email":58},"SUB_INVESTIGATOR",{"name":115,"role":88,"phone":58,"phoneExt":58,"email":58},"Yael Enav, PhD",{"type":88,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"Yael Enav","Head of Emotional Regulation and Mentalization Lab","100552710",false,"NCT06476626","Maternal Reflective Functioning During the Transition to Motherhood","Maternal Reflective Functioning During the Transition to Motherhood as a Protective Factor in the Relationship Between Personal and Environmental Characteristics and the Mental Health of Both the Mother and the Infant","Inclusion Criteria:\n\n* pregnant women in 27-30 weeks pregnant in enrollment\n* speak read and understand Hebrew\n* Has a connection to internet and ZOOM platform.\n* Ready to participate in a group workshop\n\nExclusion Criteria:\n\n* Women who can\\'t participate in a online workshop due to physical or mental health difficulties.",true,"FEMALE","18 Years",{"count":129,"type":130},200,"ESTIMATED","INTERVENTIONAL",[133],"NA","The goal of this clinical trial is to learn about Maternal Reflective Function (MRF) during the transition to motherhood. The main questions it aims to answer are:\n\nDoes MRF mediates the connection between risk factors for mental health difficulties during first pregnancy and motherhood (the transition to motherhood) and outcomes related to the mother, the infant, and their relationship.\n\nParticipants will:\n\nAnswer questionnaires and clinical interviews during pregnancy and after birth of the first child (twice at third trimester, 1 and 3 months after birth).\n\nintervention group will participate in an online short intervention to enhance MRF.",[136,137],"Pregnancy","Primiparous Women",[139,140,141,142,143,144,145],"pregnancy","primiparous women","anxiety","depression","stress","mentalization","reflective function","NOT_YET_RECRUITING","2024-07-08",{"date":149,"type":150},"2024-07-09","ACTUAL",{"date":152,"type":130},"2024-07-15",{"date":154,"type":130},"2027-08-30",{"name":5,"class":6},1]