[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mentalization\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mentalization":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100612131","recognizing-childrens-needs-impact-on-early-childhood-regulatory-problems-100612131",false,"NCT07249593","Recognizing Children's Needs: Impact on Early Childhood Regulatory Problems","Parental Recognition of Child Needs and Its Impact on Early Childhood Regulatory Problems","Inclusion Criteria:\n\n* Participants aged 18 years and older with a infant aged 6 months (± 1 month)\n* Willingness to participate in the study and follow-up\n* Ability to speak, understand and communicate fluently in Turkish.\n\nExclusion Criteria:\n\n* Mothers of infants with serious chronic conditions requiring follow-up, diagnosed after birth, even if included in the study\n* Individuals who completed the questionnaire but did not meet the questionnaire reliability criteria\n* Parents of babies with a history of preterm birth (gestational age under 37 weeks)\n* Parents of babies with a history of low birth weight (\\\u003C2500g)",true,"FEMALE","18 Years",{"count":20,"type":21},249,"ESTIMATED","30 Months","OBSERVATIONAL","Brief Summary:\n\nThis study aims to quantitatively examine the relationship between regulatory problems (sleep, feeding, and crying) in infants aged 6-36 months and levels of parental sensitivity and reflective functioning. The primary objective is to determine how parents' ability to perceive and interpret their child's cues affects these regulatory difficulties; the secondary objective is to explore how emotional responses to crying and other parent-child interaction factors mediate that relationship. In a cohort of approximately 249 infant-parent dyads, the Revised-Brief Infant Sleep Questionnaire (BISQ-R), feeding and crying assessment forms, the Parental Reflective Functioning Questionnaire, the My Emotions Questionnaire, and the Parental Stress Scale will be administered. Data will be analyzed via descriptive statistics, correlation analyses, and multiple regression models. As the first large-scale quantitative study in Turkey to investigate this area, it will yield unique data to guide parenting programs and early-intervention policies.",[26,27,28,29,30,31,32],"Regulation, Self","Reflective Functioning","Mentalization","Child Sleep","Parent-Child Relation","Crying","Feeding Problems",[34,35,36,37,38,39,28,40],"regulatory problems","maternal sensitivity","sleep","feeding","crying","Parental reflective functioning","Insightfulness","RECRUITING","2025-12-12",{"date":44,"type":45},"2025-12-15","ACTUAL",{"date":47,"type":45},"2025-12-11",{"date":49,"type":21},"2029-03-01",{"name":51,"class":52},"Marmara University","OTHER",2,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":76,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":5},"100605436","attach-in-denmark-a-feasibility-randomized-controlled-trial-100605436","NCT07162493","ATTACH in Denmark: A Feasibility Randomized Controlled Trial","Attachment and Child Health (ATTACH) Added to Treatment As Usual Versus Treatment As Usual Alone for Parents With Psychosocial Problems: A Feasibility Randomized Controlled Trial","AiD","Inclusion criteria\n\n* Child aged 0 - 5.7 years at enrollment.\n* Speaks Danish or English sufficiently to take part in assessments and intervention without an interpreter.\n* Both parents provide consent in case of shared child custody. Parents experience psycho-social problems that have resulted in referral to the family treatment center on the basis of legislation from the Danish Child Act (\"Barnets Lov\"), under the following Sections defining support needs: Section 29: Family counselling: Includes open access to family counselling as an early preventive effort. In this context, the counselling may involve referring the family to other departments within the municipality or to other relevant authorities that can provide the appropriate guidance and support. Section 30: Early preventive intervention: Includes a variety of approaches, such as consultancy services and participation in network or discussion groups to address and prevent challenges faced by the family at an early stage. Section 32: Supportive interventions: May be initiated on the basis of a preliminary assessment or a child welfare investigation pursuant to Sections 19 and 20 of the Child Act, or concurrently with the completion of such an assessment or investigation. Support may include practical, pedagogical, or other types of support in the home; appointment of a permanent contact person for the entire family; family therapy or individual treatment for the child or young person; family placement involving residential care in a foster family, an approved child and youth residential facility, or a housing facility; supportive placement in a foster family or in an approved child and youth residential facility; other forms of assistance aimed at providing counseling, treatment, and practical and pedagogical support.\n* Parents who have their child in out-of-home placement \u002Ffoster care (with or without consent).\n* Parental psychosocial problems such as (but are not limited to) mental health problems, cognitive difficulties, substance abuse, poverty, social isolation, adverse childhood experiences, functional or somatic disorders, criminal involvement, domestic violence, having a child with emotional regulation difficulties, having a child with developmental problems, having a child with functional or somatic problems, having a child with internalizing or externalizing problems.\n\nExclusion Criteria:\n\n* Child is older than 5.7 years at enrollment.\n* Parent does not speak Danish or English sufficiently to take part in assessments and intervention without an interpreter.\n* Consent cannot be obtained from both parents in case of shared child custody.\n* The parent is known to move to a different municipality within 5 months from randomization.","ALL",{"count":64,"type":21},52,"INTERVENTIONAL",[67],"NA","The goal of this feasibility randomized controlled pilot trial is to learn whether the trial can be done as planned, and to investigate if the 10-session parenting program \"ATTACH(TM) increases mentalizing skills (the ability to reflect on thoughts and feelings) in parents of children between 0-5 years of age, who are receiving support for psychosocial problems in their municipal family treatment center.\n\nThe main questions the trial aims to answer are:\n\n* How many eligible parents agree to participate in the random allocation to treatment?\n* How many parents allocated to receive \"ATTACH(TM) will have completed the program 5 months after allocation (at least 7 out of 10 sessions)?\n* How many parents complete the data collection 5 months after allocation on the primary exploratory clinical outcome, i.e., parental mentalizing skills?\n* Do parents who received the ATTACH(TM) program show more increase in their mentalizing skills, compared to parents, who did not receive treatment with ATTACH(TM)?\n\nResearchers will compare ATTACH, added to Treatment as Usual, with Treatment as Usual without ATTACH in three municipal family treatment centers located in the Capital Region of Denmark.\n\nParticipants will:\n\n1. Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills.\n2. Be randomly allocated to receive treatment in their local family center with or without ATTACH.\n3. Take part in data collection 5 months after being allocated to either group, as well as participate in an interview about their experiences with the treatment they received.\n4. After one year, the research group will follow up on the current treatment\u002Fsupport needs of the families, who were allocated to either group.",[28,70,71,72,73,74,75],"Recruitment of Participants","Adherence, Treatment","Drop Out","Parenting Intervention","Vulnerable Families","Feasibility Studies",[77,78,79,80],"parenting","mentalizing","intervention","feasibility","2025-09-17",{"date":83,"type":45},"2025-09-23",{"date":85,"type":45},"2025-09-01",{"date":87,"type":21},"2027-12-31",{"name":89,"class":52},"Johanne Smith-Nielsen",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":62,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":65,"phases":101,"briefSummary":102,"conditions":103,"keywords":113,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":136},"100591636","bridging-affect-consciousness-mentalization-and-trauma--exploring-an-integrative-treatment-approach-for-personality-disorder-pd-100591636","NCT06983002","Bridging Affect Consciousness, Mentalization and Trauma- Exploring an Integrative Treatment Approach for Personality Disorder (PD).","Affect Consciousness (AC) as an Integrated add-on Component in Mentalization-based Group Treatment for Patients With Personality Disorder (PD)- a Mixed Method Explorative Study.","Inclusion Criteria: Participation in a MBT programme for severe AvPD and\u002For BPD 2025-2035. Half the participants join an AC group as add on to standard MBT based on randomisation on a cluster level, 25 % of the rest of the 50% representing the control group patientsample join an Body Awareness Group as add on to proper MBT and the last 25%, representering the control group participates in an Art psychotherapy group as add on to MBT, Norwegian language proficiency, age 20- 40 years.\n\nExclusion Criteria: Diagnosed with schizotypal or antisocial PD, psychotic- or bipolar I disorder, pervasive developmental disorder, ongoing drug\u002F alcohol dependence, organically contingent symptoms and\u002For attention deficit hyperactivity disorder if not effectively treated with medication.","20 Years","40 Years",{"count":100,"type":21},300,[67],"Study background: Specialized Group Outpatient Clinic within specialist mental health services, tailoring two year group treatment programmes for severe Avoidant PD (AvPD) and Borderline PD (BPD) with Affect Consciousness (AC) targeting specific areas of emotional dysfunction. Aims: Our main hypothesis, adding AC to Mentalization- based treatment (MBT) to expand the breadth and depth of therapeutically productive work on affect, will aim to examine health indicators, processes and mechanisms of change in depth. The study will extracts preliminary data after 5 years and 10 years to investigate clinical change, variation and outcome during MBT for PD employing AC as add on to MBT. The study has a randomized controlled trail design, with MBT with or without AC as add-on. The RCT is grounded on original literature on Affect Theory, as a framework for understanding patient functioning, and MBT, framing the therapy.Implications: AC methodology as add on can lead to more tailored treatment programmes, service planning, allocation of resources, guidelines, ACI certification and method development for PDs.",[104,105,106,107,108,109,28,27,110,111,112],"Personality Disorder, Borderline","Personality Trait","Personality Disorder","Personality Type","Personality Disorder, Avoidant","Affect Consciousness","PTSD","PTSD - Post Traumatic Stress Disorder","PTSD and Trauma-related Symptoms",[114,115,109,116,117,118,119,120,121,122,123,124],"Affect Integration","RCT","MBT","AvPD","BPD","Trauma","Personality Disorder (PD)","Personality functioning","Emotional dysfunction","Bodily Awareness","Art Therapy","NOT_YET_RECRUITING","2025-05-13",{"date":128,"type":45},"2025-05-21",{"date":130,"type":21},"2025-05-19",{"date":132,"type":21},"2035-04-19",{"name":134,"class":135},"Helse Stavanger HF","OTHER_GOV",1]