[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457173":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":70,"collaborators":72,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":18,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":18,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":18,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PriCARE\u002FCARIÑO plus Usual Care","EXPERIMENTAL","Caregiver-child dyads assigned to the PriCARE\u002FCARIÑO plus usual care group will receive the PriCARE\u002FCARIÑO intervention within 4 months of randomization plus usual care. The intervention will last 6 weeks. Each group, administered by 1-2 trained mental health professionals, will have approximately 4-10 caregiver participants and will meet weekly for 6 weeks. Each of the 6 sessions is approximately 80 minutes. Caregivers are expected to practice the skills they learn with their children between sessions.",[13],"Behavioral: PriCARE\u002FCARIÑO",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","Caregiver-child dyads assigned to the usual care group will receive usual care and will not be aware of being in a group of about 8-10 recently-enrolled subjects.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","PriCARE\u002FCARIÑO","PriCARE\u002FCARIÑO is a group caregiver training program designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. Sessions occur in the primary care clinic or virtually. PriCARE\u002FCARIÑO uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches skills for giving effective commands in order to set age-appropriate limits and increase compliance. PriCARE\u002FCARIÑO includes a stress education section that contextualizes the use of these skills with the types of behaviors and problems exhibited by many children living with psychosocial adversity and familial stress. Caregivers are encouraged to practice the skills with their child in between sessions. CARIÑO is the culturally adapted version of PriCARE for Spanish speaking participants.",[9],[26,27],"Child Adult Relationship Enhancement in Primary Care","Criando Niños con CARIÑO",[29],{"name":30,"affiliation":5,"role":31},"Samantha Schilling, MD, MSHP","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":18,"email":36},"CONTACT","919-966-2504","samantha_schilling@med.unc.edu",[38,54],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of North Carolina Chapel Hill","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-79.05584,35.9132,{"lat":50,"lon":49},[53],{"name":30,"role":34,"phone":35,"phoneExt":18,"email":36},{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":44,"countryCode":45,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Children's Hospital of Philadelphia","NOT_YET_RECRUITING","Philadelphia","Pennsylvania","19146",{"type":47,"coordinates":61},[62,63],-75.16362,39.95238,{"lat":63,"lon":62},[66],{"name":67,"role":34,"phone":68,"phoneExt":18,"email":69},"Joanne Wood, MD, MSHP","267-426-3107","woodjo@chop.edu",{"type":71,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[73,76],{"name":74,"class":75},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":55,"class":6},"100457173","child-adult-relationship-enhancement-in-primary-care-pricare--criando-nios-con-cario-cario-100457173",false,"NCT05233150","Child-Adult Relationship Enhancement in Primary Care (PriCARE) \u002F Criando Niños Con CARIÑO (CARIÑO)","Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children","Inclusion Criteria:\n\n* Caregiver is age 18 years or older\n* Caregiver is English or Spanish Speaking\n* Caregiver is legal guardian of child subject\n* Caregiver provides informed consent\n* Caregiver is available to attend scheduled times of PriCARE\u002FCARIÑO groups\n* Caregiver has cellular phone with text messaging capacity\n* Caregiver has appropriate technological tools and access to participate in virtual intervention\n* Child is between 18 months and 6 years old\n* Child receives care at participating primary care center\n* Child has Medicaid\u002FChildren's Health Insurance Program (CHIP)\u002Fno insurance\n* Child lives in North Carolina or Philadelphia\n\nExclusion Criteria:\n\n* Caregiver or another caregiver in the household has previously participated in PriCARE\u002FCARIÑO\n* Child has a cognitive functioning below 2-year-old level, as determined by the screening questions and\u002For the referring clinician\n* Child has a diagnosis of autism\n* Child is receiving individual behavioral health treatment or medication for a behavioral health problem",true,"ALL","18 Months","99 Years",{"count":89,"type":90},1932,"ESTIMATED","INTERVENTIONAL",[93],"NA","The purpose of this study is evaluate the effectiveness of PriCARE\u002FCARIÑO to reduce child maltreatment, improve parent-child interactions, and reduce harsh\u002Fneglectful parenting, parent stress, and child behaviors.",[96,97],"Parent-Child Relations","Child Maltreatment","2026-04-29",{"date":100,"type":101},"2026-05-01","ACTUAL",{"date":103,"type":101},"2022-05-18",{"date":105,"type":90},"2027-07-01",{"name":5,"class":6},2]