NCT06363695 Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya
| NCT ID | NCT06363695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pacific University |
| Condition | Child Maltreatment |
| Study Type | INTERVENTIONAL |
| Enrollment | 369 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 369 participants in total. It began in 2024-03-14 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Parents Inclusion Criteria: * being the female primary caregiver * at least 18 years old of age * at least one child between 18 months and age 5 * reside in Kibera * have ability to participate virtually (i.e., owns a smart phone) in English or Swahili. Parent Exclusion Criteria: * younger than 18 years old * unable to participate in English or Swahili * does not own smart phone to participate in virtual sessions. CHV Inclusion Criteria: * 18 years or older * able to participate in English or Swahili * has ability to participate virtually (i.e., owns a smart phone) * female community health volunteer who is affiliated with one of the project's agencies in Kibera CHV Exclusion Criteria: * younger than 18 years old * not able to participate in English or Swahili * does not have a smart phone * is not female * is not a community health volunteer affiliated with one of the project's agencies Trainer Inclusion Criteria: * 18 years or older * able to participate in English and Swahili * trained as a SafeCare trainer Trainer Exclusion Criteria: * younger than 18 years old * not able to participate in English and Swahili * not trained as a SafeCare Trainer Stakeholder Inclusion Criteria: * 18 years or older * able to participate in English * involved in the project as a stakeholder Stakeholder Exclusion Criteria: * younger than 18 years old * not able to participate in English * not a stakeholder for this project
Contact & Investigator
Jenelle R. Shanley, PhD
PRINCIPAL INVESTIGATOR
Pacific University
Frequently Asked Questions
Who can join the NCT06363695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Child Maltreatment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06363695 currently recruiting?
Yes, NCT06363695 is actively recruiting participants. Contact the research team at jshanley@pacificu.edu for enrollment information.
Where is the NCT06363695 trial being conducted?
This trial is being conducted at Nairobi, Kenya.
Who is sponsoring the NCT06363695 clinical trial?
NCT06363695 is sponsored by Pacific University. The principal investigator is Jenelle R. Shanley, PhD at Pacific University. The trial plans to enroll 369 participants.