protocolSection identificationModule nctId: NCT06363695, orgStudyIdInfo id: 131-22, secondaryIdInfos id: 1R01HD112043-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01HD112043-01, briefTitle: Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Pacific University, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), collaborators name: Africa Mental Health Research and Training Foundation, collaborators name: Georgia State University, descriptionModule briefSummary: 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:* Will SafeCare Kenya improve child and parent outcomes?* Is virtual delivery as effective as in-person delivery of SafeCare Kenya?* Is SafeCare Kenya feasible to deliver by community health volunteers?Mothers will:* Complete study assessments at three timepoints: baseline, 6 months and 18 months* Mothers in the SafeCare Kenya group will receive the program from their community health volunteerResearchers 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., conditionsModule conditions: Child Maltreatment, conditions: Parenting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 369, type: ESTIMATED, armsInterventionsModule interventions name: SafeCare Kenya, interventions name: Care as Usual by Community Health Volunteers, outcomesModule primaryOutcomes measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months, primaryOutcomes measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months, primaryOutcomes measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months, primaryOutcomes measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months, primaryOutcomes measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months, primaryOutcomes measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months, primaryOutcomes measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months, primaryOutcomes measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months, secondaryOutcomes measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months, secondaryOutcomes measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months, secondaryOutcomes measure: Change from Baseline in scores on Parenting Stress Index at 6 months, secondaryOutcomes measure: Change from Baseline in scores on Parenting Stress Index at 18 months, secondaryOutcomes measure: Change from Baseline in score on Childhood injuries at 6 months, secondaryOutcomes measure: Change from Baseline in score on Childhood injuries at 18 months, secondaryOutcomes measure: Change from Baseline in score on Child Quality of Life at 6 months, secondaryOutcomes measure: Change from Baseline in score on Child Quality of Life at 18 months, secondaryOutcomes measure: Change from Baseline in score on Parent Quality of Life at 6 months, secondaryOutcomes measure: Change from Baseline in score on Parent Quality of Life at 18 months, otherOutcomes measure: Client satisfaction, otherOutcomes measure: Provider fidelity, otherOutcomes measure: Parent Interview, otherOutcomes measure: Provider Interview, otherOutcomes measure: Trainer Interview, otherOutcomes measure: Stakeholder Interview, otherOutcomes measure: Readiness Assessment for the Prevention of Child Maltreatment (RAP-CM), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Africa Mental Health Research and Training Foundation, status: RECRUITING, city: Nairobi, country: Kenya, contacts name: Victoria Mutiso, PhD, role: CONTACT, phone: (254) 202 651 360, email: vmutiso@amhf.or.ke, contacts name: Christine Musyimi, PhD, role: CONTACT, phone: (254) 202 651 360, email: christine.musyimi@amhf.or.ke, contacts name: David Ndetei, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -1.28333, lon: 36.81667, hasResults: False