[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100375228":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":43,"locations":48,"responsibleParty":68,"collaborators":71,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":24,"maxAge":97,"enrollmentInfo":98,"targetDuration":24,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":111,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced Institutional Care","EXPERIMENTAL","Caregivers at institutions will participate in a caregiving training, called Attachment VideoFeedback Intervention (AVI). During AVI a trained interventionist meets with a caregiver and child in the home environment.\n\nThe AVI Interventionist will meet with caregivers and children for 8, 1.5-hours sessions over 8-9 weeks to discuss recordings of children and their caregivers. As described above, the sessions will focus on creating a positive atmosphere by reinforcing positive interactions.",[13],"Behavioral: Caregiving Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Enhanced Foster Care","Foster parents will be recruited, consented to background checks, and trained in Portuguese. Hired foster parents will supported and monitored by project social workers and psychologists from local Foster Care programs. Foster parents will received frequent visits from the social workers, with visits occurring weekly for several months after placement of the child, then biweekly and later monthly. Project social workers will consult weekly with US staff experienced in dealing with young children in foster care.\n\nAdditionally, foster parents will participate in the VIPP caregiving training, in the same format as that described in the Enhanced Institutional Care Arm: the VIPP Interventionist will meet with caregivers and children for 5, 2-hours sessions over 6-8 weeks to discuss recordings of children and their caregivers. As described above, the sessions will focus on creating a positive atmosphere by reinforcing positive interactions.",[18,13],"Other: Foster Care",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Foster Care","Upon entry into the Child Protection System, if the child is assigned to one of the districts participating in the RCT, the court will notify the study team. Children that have been randomly assigned to Foster Care will be placed in a foster home within 48 hours of referral to the Family Court\u002FChild Protection System.\n\nChildren and Foster Parents will receive biweekly visits from Social Workers. Children and Foster parents will also participate in the caregiving intervention described below. Children will remain in the placement until such time as the social workers, psychologists and Family Court Judge determine that one of the following outcomes is appropriate: reunification with biological family or adoption.",[15],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Caregiving Intervention","During AVI an intervenor meets with a caregiver (foster parent or caregiver at the institution) and child in the home environment. During each session, the intervenor videotapes the caregiver and child doing play-based activities. During that meeting, the intervenor reviews the videos with the caregiver and provides positive, constructive feedback to the caregiver. AVI is aimed at increasing sensitivity in parents\u002Fcaregivers in order to encourage positive interactions. The guiding principles are to create a positive environment and to convey that the caregiver is the expert on their own child. The AVI methodology was selected to be used as a method of caregiving intervention with the study participants due to its demonstrated results in its use with children in contexts of social vulnerability, as well as families included in the child protection system. This will be the first time that AVI is being used in foster and institutional care in Brazil.",[15,9],[31],"Attachment Video Feedback intervention",[33,37,40],{"name":34,"affiliation":35,"role":36},"Nathan A Fox, PhD","University of Maryland","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":36},"Charles A Nelson, PhD","BOSTON CHILDRENS HOSPITAL\u002F Harvard University",{"name":41,"affiliation":42,"role":36},"Charles H Zeanah, PhD","Tulane University School of Medicine",[44],{"name":38,"role":45,"phone":46,"phoneExt":24,"email":47},"CONTACT","617-355-0401","charles.nelson@childrens.harvard.edu",[49],{"facility":50,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Instituto PENSI","RECRUITING","São Paulo","01228-200","Brazil","BR",{"type":57,"coordinates":58},"Point",[59,60],-46.63611,-23.5475,{"lat":60,"lon":59},[63,67],{"name":64,"role":45,"phone":65,"phoneExt":24,"email":66},"Edson Amaro, MD, PhD","+55 11 2155-9358","edson.amaro@gmail.com",{"name":64,"role":36,"phone":24,"phoneExt":24,"email":24},{"type":36,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Charles Alexander Nelson III","Richard David Scott Chair in Pediatric Developmental Medicine Research, Professor of Pediatrics and Neuroscience",[72,74,76,78,80,82,84,86],{"name":73,"class":6},"University of Maryland, College Park",{"name":75,"class":6},"Tulane University",{"name":50,"class":77},"UNKNOWN",{"name":79,"class":6},"Harvard University",{"name":81,"class":6},"Inter-American Development Bank",{"name":83,"class":77},"Lumos Foundation",{"name":85,"class":77},"Two Lilies Fund",{"name":87,"class":6},"Fundação Maria Cecilia Souto Vidigal","100375228","early-institutionalization-intervention-impact-project-100375228",false,"NCT04165746","Early Institutionalization Intervention Impact Project","EI-3","Inclusion Criteria:\n\n* newly entering the institution system in and near São Paulo, Brazil, and the institution director or foster parent is the guardian at the time of baseline,\n* at the time of baseline assessment the child is less than 24 months old,\n* the child's birth weight must be at or above 2500 grams; none should be small or large for dates.\n\nExclusion Criteria:\n\n* the child does not have a neurological or other genetic condition that severely impairs typical development (e.g. Cerebral Palsy, Fetal Alcohol Syndrome, Down Syndrome)\n* the child is below 2500 grams.",true,"ALL","24 Months",{"count":99,"type":100},220,"ESTIMATED","INTERVENTIONAL",[103],"NA","The purpose of this study is to determine the effects of early intervention (placement into foster care, and a caregiving training) on physical, cognitive, social and brain development and psychiatric symptomatology in children place in out-of-home care.",[106,107,108,109,110],"Socioemotional Development","Cognitive Ability","Behavioral and Neural Patterns of Attention","Brain Function","Psychopathology",[54,112,113,114,115,116,117,118,119,120],"children","foster care","institutionalization","attachment","brain function","language","growth","Intelligence Quotient (IQ)","early intervention","2026-03-16",{"date":123,"type":124},"2026-03-18","ACTUAL",{"date":126,"type":124},"2023-03-16",{"date":128,"type":100},"2029-03-31",{"name":5,"class":6},1]