[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544039":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":47,"locations":55,"responsibleParty":76,"collaborators":78,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":36,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":36,"enrollmentInfo":95,"targetDuration":36,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":36,"overallStatus":57,"whyStopped":36,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Pacific University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Care as Usual","ACTIVE_COMPARATOR","Community Health Volunteers will continue their usual services with families. This is typically done on a monthly basis focused on physical health needs of the mother and\u002For child.",[13],"Other: Care as Usual by Community Health Volunteers",{"label":15,"type":16,"description":17,"interventionNames":18},"SafeCare Kenya In-Person","EXPERIMENTAL","Community Health Volunteers randomized to SafeCare Kenya will be trained to deliver this program either virtually or in-person. The Community Health Volunteer's families enrolled in the study will be randomized to receive the program either virtually or in-person. For in-person families, the Community Health Volunteer will deliver the session in the mother's home. The SafeCare Kenya curriculum will be the same in both the virtual and in-person.",[19],"Behavioral: SafeCare Kenya",{"label":21,"type":16,"description":22,"interventionNames":23},"SafeCare Kenya Virtual","Community Health Volunteers randomized to SafeCare Kenya will be trained to deliver this program either virtually or in-person. The Community Health Volunteer's families enrolled in the study will be randomized to receive the program either virtually or in-person. For in-person families, the Community Health Volunteer will deliver the session via a virtual platform (e.g., Zoom). The SafeCare Kenya curriculum will be the same in both the virtual and in-person.",[19],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","SafeCare Kenya","Adapted from SafeCare, this is a strengths-based program for parents with children ages 18 months through age 5, teaching parents skills and knowledge in three areas: 1) parent-child interactions, 2) child health, and 3) home safety.",[15,21],[31],"SafeCare",{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Care as Usual by Community Health Volunteers","Community Health Volunteers support families with children up to age 5 around the physical health needs of family members, including delivering key health messages (e.g., importance of immunizations); treating minor injuries and illnesses; identifying\u002Ftreating\u002Freferring common childhood illnesses (e.g., diarrhea, malaria); conducting home visits to evaluate the home environment and discuss improvements; and encouraging care at home and appropriate health seeking behaviors. These support services are not highly structured but rather tailored to the needs of each family.",[9],null,[38,41,44],{"name":39,"affiliation":5,"role":40},"Jenelle R. Shanley, PhD","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":40},"David Ndetei, MD","Africa Institute of Mental and Brain Health",{"name":45,"affiliation":46,"role":40},"Lisa P. Armistead, PhD","Georgia State University",[48,52],{"name":39,"role":49,"phone":50,"phoneExt":36,"email":51},"CONTACT","503-352-6438","jshanley@pacificu.edu",{"name":45,"role":49,"phone":53,"phoneExt":36,"email":54},"404-413-2091","lparmistead@gsu.edu",[56],{"facility":43,"status":57,"city":58,"state":36,"zip":36,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Nairobi","Kenya","KE",{"type":62,"coordinates":63},"Point",[64,65],36.81667,-1.28333,{"lat":65,"lon":64},[68,72,75],{"name":69,"role":49,"phone":70,"phoneExt":36,"email":71},"Victoria Mutiso, PhD","(254) 202 651 360","vmutiso@amhf.or.ke",{"name":73,"role":49,"phone":70,"phoneExt":36,"email":74},"Christine Musyimi, PhD","christine.musyimi@amhf.or.ke",{"name":42,"role":40,"phone":36,"phoneExt":36,"email":36},{"type":77,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[79,82,83],{"name":80,"class":81},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":46,"class":6},{"name":43,"class":84},"UNKNOWN","100544039","building-community-health-volunteers-capacity-to-support-parents-with-young-children-with-safecare-kenya-100544039",false,"NCT06363695","Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya","Implementing the Adapted Parenting Program, SafeCare Kenya, to Reduce Noncommunicable Disease Burden: Building Community Health Volunteers' Capacity to Support Parents With Young Children","Parents Inclusion Criteria:\n\n* being the female primary caregiver\n* at least 18 years old of age\n* at least one child between 18 months and age 5\n* reside in Kibera\n* have ability to participate virtually (i.e., owns a smart phone) in English or Swahili.\n\nParent Exclusion Criteria:\n\n* younger than 18 years old\n* unable to participate in English or Swahili\n* does not own smart phone to participate in virtual sessions.\n\nCHV Inclusion Criteria:\n\n* 18 years or older\n* able to participate in English or Swahili\n* has ability to participate virtually (i.e., owns a smart phone)\n* female community health volunteer who is affiliated with one of the project's agencies in Kibera\n\nCHV Exclusion Criteria:\n\n* younger than 18 years old\n* not able to participate in English or Swahili\n* does not have a smart phone\n* is not female\n* is not a community health volunteer affiliated with one of the project's agencies\n\nTrainer Inclusion Criteria:\n\n* 18 years or older\n* able to participate in English and Swahili\n* trained as a SafeCare trainer\n\nTrainer Exclusion Criteria:\n\n* younger than 18 years old\n* not able to participate in English and Swahili\n* not trained as a SafeCare Trainer\n\nStakeholder Inclusion Criteria:\n\n* 18 years or older\n* able to participate in English\n* involved in the project as a stakeholder\n\nStakeholder Exclusion Criteria:\n\n* younger than 18 years old\n* not able to participate in English\n* not a stakeholder for this project",true,"ALL","18 Years",{"count":96,"type":97},369,"ESTIMATED","INTERVENTIONAL",[100],"NA","The goal of this clinical trial is to implement and examine the impact of SafeCare Kenya, an adapted parenting program, to improve parents' skills and knowledge related to the care of their children between the ages of 18 months and 5 years old. The main questions it aims to answer are:\n\n* Will SafeCare Kenya improve child and parent outcomes?\n* Is virtual delivery as effective as in-person delivery of SafeCare Kenya?\n* Is SafeCare Kenya feasible to deliver by community health volunteers?\n\nMothers will:\n\n* Complete study assessments at three timepoints: baseline, 6 months and 18 months\n* Mothers in the SafeCare Kenya group will receive the program from their community health volunteer\n\nResearchers will compare SafeCare Kenya to care as usual by community health volunteers to see if SafeCare Kenya families show improvements in parent interaction skills, safety and health knowledge, potential for child abuse, child behavior problems, child injuries, parenting stress, and child and parent quality of life.",[103,104],"Child Maltreatment","Parenting","2025-04-15",{"date":107,"type":108},"2025-04-18","ACTUAL",{"date":110,"type":108},"2024-03-14",{"date":112,"type":97},"2028-05",{"name":5,"class":6},1]