[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"child-of-impaired-parents\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:child-of-impaired-parents":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100577211","wellbeing-and-resilience-among-1-3-years-old-children-of-mothers-with-complex-mental-health-problems-a-pragmatic-clinical-trial-of-online-vipp-sd-vs-care-as-usual-100577211",false,"NCT06795347","Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial of Online VIPP-SD Vs. Care As Usual","Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial","WellCom","Inclusion Criteria:\n\n* child age 1 year, 0 months until 3 years, 0 months\n* living with their mother in the Region of Southern Denmark\n* mother has a mental disorder (Schizophrenia ICD-10: F20-29, Bipolar disorder ICD-10: F30-31, Moderate to severe depression ICD-10: F32-33 or Emotionally unstable personality disorder F60.3) verified in the Danish National Hospital Register-Psyk\u002Fthe Danish Psychiatric Central Research Register or by a clinician at the mental health services via the patient record\n* mother has had at least one in- or outpatient contact with mental health services within 12 months before birth of the child or during the child's lifetime verified in the Danish National Hospital Register or by a clinician at the mental health services via the patient record\n\nExclusion Criteria:\n\n* current in-patient status of the mother\n* current substance or alcohol abuse of the mother\n* mother has insufficient knowledge of Danish (interpreter required)\n* repeated intrauterine exposure to euphoriants or large amounts of alcohol (≥5 units per time or ≥7units per week) of the child\n* known syndrome or autism spectrum disorder of the child\n* mother or child has sensory impairment\n* sibling participating in study\n* family participating in another closely related research trial receiving an individualized video-feedback intervention\n* participating in active court proceedings","ALL","1 Year","3 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"NA","Children of parents with severe mental disorders have an increased risk of mental disorders themselves, with more than half of this population diagnosed with a mental health condition during their life time. Already during early childhood, the risk of a mental health diagnosis is elevated by a factor 2-5, compared to children of parents without severe mental disorders. This highlights the need for preventive interventions.\n\nMental health during early childhood is inextricably linked with early parent-child interaction. Sensitive parenting plays a crucial role in the socio-emotional development of the child, and severe parental mental disorders may affect the quality of parent-child interaction.\n\nTherefore, we will test the effect of an intervention promoting sensitive parenting on mental health outcomes of 1-3 years old children of parents with severe mental disorders. The intervention will be tested in a randomized clinical trial comparing the intervention \"Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline\" (VIPP-SD) delivered online to Care As Usual. Our hypothesis is, that children in the Intervention Group will display lower levels of behavioral problems and increased attachment security compared to children in the Care As Usual Group.\n\nThe study will be conducted in the department of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark. Participants are mothers with a diagnosis of schizophrenia, bipolar disorder, emotionally unstable personality disorder or moderate to severe depression living in the Region of Southern Denmark with their 1-3 years old child, and the father\u002Fcohabitating partner. Participants will be recruited via psychiatric outpatient clinics in the region or on the basis of information from health registers.\n\nThe primary outcome of the study is child behavioral problems. Secondary child outcomes are attachment security and mental health. Parental outcomes are parental stress and quality of life. Child cognition, parental psychiatric symptoms, childhood trauma, sensitivity, parental reflective functioning and service use data are also assessed in the study. Data are collected at baseline as well as 5 and 11 months after randomization. All participants will have the opportunity to receive feedback on their child's cognitive functioning and mental health status at baseline and at the end of the study.\n\nAfter baseline assessments, participants will be randomized to either intervention or the control group.\n\nThe intervention, VIPP-SD, is delivered online apart from the first session, which is conducted as a home visit. VIPP-SD is based on attachment and social learning theory. It is manualized and consists of 12 individual sessions alternating between video-recording of mother and child in pre-defined everyday situations and review\u002Fdiscussion of the video recordings with the mother\u002Fparents. Focus of the intervention is the childs signals and needs, and how to promote healthy socio-emotional development of the child. VIPP-SD will be carried out by health care professionals trained and certified in VIPP-SD.\n\nParticipants who are randomized to the control condition, Care As Usual, will continue as they did before enrollment to the study. Care As Usual is defined as any kind of help and support related to the social-emotional development and mental wellbeing of the child in the municipality or mental health services.",[28,29,30],"Child Mental Health","Behavioral Symptoms","Child of Impaired Parents",[32,33,34,35,36,37,38],"Parental psychiatric disorder","Child mental disorders","Prevention","Socio-emotional development","Child behavioral problems","Child externalizing problems","Parental sensitivity","RECRUITING","2025-01-25",{"date":42,"type":43},"2025-01-28","ACTUAL",{"date":45,"type":22},"2025-02",{"date":47,"type":22},"2028-01-31",{"name":49,"class":50},"University of Southern Denmark","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":51},"100540097","the-via-family-20---a-family-based-intervention-for-families-with-parental-mental-illness-100540097","NCT06312410","The VIA Family 2.0 - a Family Based Intervention for Families with Parental Mental Illness","The VIA Family 2.0 Study: a Randomized Clinical Trial Evaluating Family-based Interventions for Children Born to Parents with Mental Disorders","Inclusion Criteria:\n\n* At least one of the parents must be living in Capital Region or in Region North, Denmark, and at least one biological child under age 18 must be living with one of the parents. Only biological children of the parent with at mental health problem can be included.\n* The parent with the mental health problems has at some point been diagnosed in the secondary sector and has within the last three years been treated in the primary sector (GP or private psychiatric clinic) or in the secondary sector (hospital psychiatry).\n* Patients with substance abuse can only be included if substance abuse is a secondary diagnosis to another mental illness disorder being treated within the secondary sector during the last three years.\n* All adult participants must give informed consent. Both parents will need to consent in case of shared custody, but do not have to participate if they are reluctant to do so.\n\nExclusion Criteria:\n\n* Not fulfilling inclusion criteria\n* Not giving informed consent\n* Living at Læsø or at Bornholm, Denmark\n* Children placed in care outside of the home fulltime in institution of professional family care (the family is not excluded if the children placed in part time in care outside home or fulltime family care within the family)\n* No risk factors found after baseline assessment (as described in the stepped care model) at baseline - these families can be re-referred if their situation changes.\n* Ongoing intensive family treatment in the municipality (for example staying at an institution for parental evaluation by the authorities)?","0 Years","17 Years",{"count":62,"type":22},1452,[25],"VIA Family 2.0 - a Family Based Intervention for families with parental mental illness\n\nBackground: Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders, somatic disorders, poorer cognitive functioning, social, emotional and behavioral problems and lower quality of life. Further these children are often overlooked by both society and mental health services, although they represent a potential for prevention and early intervention.\n\nA collaboration between researchers and clinicians from two regions, the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions. The research center is an umbrella for a series of research activities, all focusing on children and adolescents in families with parental mental illness.\n\nMethod: A large randomized, controlled trial (RCT) for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary, holistic team intervention (the VIA Family 2.0 team intervention) against treatment as usual (TAU). Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years. A total of 870 children or approx. 600 families will be included from two sites. Primary outcomes will be changes in child well being, parental stress, family functioning and quality of the home environment, .\n\nTime plan: The RCT will start including families from March 1st, 2024 to Dec 2025 (or later if needed). All families will be assessed at baseline and at end of treatment, i.e. after 24 months and after 36 months. Baseline data will inform the intervention team about each family's needs, problems, and motivation. TAU will be similar in the two regions, which means three family meetings and option for children to participate in peer groups.\n\nChallenges: final funding is being applied for. Recruitment of families can be challenging but we have decades of experience in conducting research in the field. Since both the target group, their potential problems and the intervention is complex, primary outcome is difficult to determine.",[66,67,68,30,69],"Child","Parents","Mental Disorder","Preventive Health Services",[71,72,73,74,75],"family based intervention","early intervention","familial high risk","COPMI - children of parents with mental illness","parental mental illness","2024-10-23",{"date":78,"type":43},"2024-10-26",{"date":80,"type":43},"2024-03-18",{"date":82,"type":22},"2028-12-31",{"name":84,"class":50},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital"]