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Clinical Trial Summary

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 volunteer Researchers 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.


Clinical Trial Description

After being informed about the study and potential risks, all community health volunteers consented to the study will be randomized to continue their usual services with families or be trained to deliver SafeCare Kenya to add to their usual services with families. All community health volunteers will inform their eligible families about the study and share with the research team mothers who express interest in the study. After being informed about the study and potential risks, all mothers giving informed consent will complete a baseline assessment, along with a 6 month and 18 month follow up assessment. Mothers whose community health volunteer is assigned to the SafeCare Kenya program will receive the program from their community health volunteers. All SafeCare Kenya mothers will be randomized to receive the program either in-person or virtually. Trainers and Stakeholders will provide information about their involvement in the project. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06363695
Study type Interventional
Source Pacific University
Contact Jenelle R. Shanley, PhD
Phone 503-352-6438
Email jshanley@pacificu.edu
Status Recruiting
Phase N/A
Start date March 14, 2024
Completion date May 2028

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