[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476960":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":55,"collaborators":58,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Minho","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate Intervention Group (IIG)","EXPERIMENTAL","Participants receive initially one session for psychological assessment. At the end of the session, the second session is scheduled for the following week, where feedback about the assessment will be provided. If in the second session participants agree to proceed with the psychological intervention, then the remaining 4-6 sessions of Skills4Parenting+ are conducted.",[13],"Behavioral: Skills4Parenting+",{"label":15,"type":6,"description":16,"interventionNames":17},"Delayed Intervention Group (DIG)","Waiting-list Comparator (nocebo): Participants initially receive one session for psychological assessment. At the end of the session, participants are informed that they will be contacted to schedule the second session, where feedback about the assessment will be provided. Participants are contacted during the same week, to schedule the second session 8 weeks after the first session. If in the second session participants agree to proceed with the psychological intervention, then the remaining 4-6 sessions of Skills4Parenting+ are conducted.",[18],"Other: Waiting-list (nocebo)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Skills4Parenting+","Skills4Parenting+ has 6-8 weekly individual online sessions (50 min) + 8-week follow-up. First, an assessment session of parents' positive parenting skills (PPS), based on mother\u002Ffather-child interaction observation. The following sessions aim to (1) promote parental reflective functioning, enhancing parents' understanding of the child´s problems, and (2) activate PPS to solve the child's problems. Written registers of problematic situations - in which the problems of the child occur, are analyzed (i.e., child's and parents' behaviors, thoughts, and feelings) (intersession activity) - are reflected upon, to understand and solve through PPS. PPS implementations are analyzed to understand the changes in the child and parent. Future situations and activation of appropriate PPS are anticipated, to solve potential upcoming problems of the child's, related to adversity. When the therapeutic goals have not been fully achieved, two additional sessions (total of 8 instead of 6), are added.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Waiting-list (nocebo)","Participants wait to receive the psychological intervention (Skills4Parenting+) for eight weeks, after the assessment session.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Bárbara Figueiredo","CONTACT","939993937","+351","bbfi@psi.uminho.pt",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Braga","Braga District","4710-057","Portugal","PT",{"type":46,"coordinates":47},"Point",[48,49],-8.42311,41.5514,{"lat":49,"lon":48},[52],{"name":5,"role":33,"phone":53,"phoneExt":35,"email":54},"253 601 100","gcii@reitoria.uminho.pt",{"type":56,"investigatorFullName":32,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Associate Professor with Aggregation",[59,61,64,66],{"name":60,"class":6},"Foundation for Science and Technology, Portugal",{"name":62,"class":63},"Psychology Research Center (CIPsi)","UNKNOWN",{"name":65,"class":63},"Psychology Association of the University of Minho (aPsi-UMinho)",{"name":67,"class":63},"ProChild CoLAB - The Collaborative Laboratory against child poverty and social exclusion","100476960","psychological-intervention-for-child-mental-health-based-on-parental-reflective-functioning-to-enhance-positive-parenting-100476960",false,"NCT05490745","Psychological Intervention for Child Mental Health Based on Parental Reflective Functioning to Enhance Positive Parenting","A Psychological Intervention for Children's Mental Health Problems or Disorders Based on Parental Reflective Functioning to Enhance Positive Parenting During Adverse Situations","SK4Parenting+","Inclusion Criteria:\n\n* Age between 3 and 6 years old, inclusive\n* Signaling in the screening (≥16 in the SDQ total scale)\n* CBCL (i.e., ≥60 on the Internalizing and\u002For Externalizing Scale) OR Parents report a high pandemic impact\n* Parental informed consent and commitment to the planned psychological intervention.\n* Parent is the child's legal guardian\n\nExclusion Criteria:\n\n* Already receiving psychological intervention\n* Presence of psychological problems not related to an adverse situation or not likely to be monitored within the scope of the proposed intervention (for example, autism spectrum or intellectual development disorders or, domestic violence, neglect or abuse prior to the adverse situation);\n* Do not speak or understand Portuguese","ALL","3 Years","6 Years",{"count":80,"type":81},60,"ESTIMATED","INTERVENTIONAL",[84],"NA","In this study we aim to verify the effectiveness of a psychological intervention for preschool children, 3 to 6 years of age, with psychological problems or disorders, arising from adversity, Skills4Parenting+.\n\nSkills4Parenting+, with 6 to 8 weekly sessions, aims to treat the child's psychological problems or disorders, based on parental reflective functioning, to activate and develop parents' positive parenting skills, in response to situations of adversity.\n\nTo assess the effectiveness, we plan to conduct an a simple two-arm RCT study, where children are randomly allocated to an immediate intervention group (IIG) or a delayed intervention group (DIG).\n\nThe IIG will be assessed at 3 time-points: Time 0 (pre-test: before the 1st session); Time 1 (post-test: after the last session) and Time 2 (follow-up: 8 weeks after the last session). The DIG will be assessed at 4 time-points: Time 0 (pre-test 1: before the 1st session); Time 0+ (pre-test 2: 8 weeks after the 1st session); Time 1 (post-test: after the last session) and Time 2 (follow up: 8 weeks after the last session). A time period of 8 weeks will be maintained between each time point.\n\nIn this study, we expect the (1) psychological intervention to significantly diminish the child's psychological problems or disorders (from pretest to posttest); (2) parental reflective functioning will mediate the effect of the psychological intervention on child's psychological problems or disorders; (3) the children from IIG will demonstrate a significant improvement in their mental health, in comparison to the children from the DIG; and (4) for the effects of the psychological intervention (i.e., improvement in the child's mental health) to be maintained in the medium-term (from posttest to follow-up).",[87,88],"Externalizing Problems","Internalizing Problems",[90,91,92,93,94,95,96],"Positive Parenting","Pre-school Children","Parents","Adversity","Psychological Problems","Parental Reflective Functioning","Psychological Disorders","2025-04-04",{"date":99,"type":100},"2025-04-08","ACTUAL",{"date":102,"type":100},"2021-02-04",{"date":104,"type":81},"2025-12-31",{"name":5,"class":6},1]