Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-29 @ 8:36 PM
Study NCT ID:
NCT06363695
Status:
RECRUITING
Last Update Posted:
2025-04-18
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya
Sponsor:
Pacific University
Organization:
Study Overview
Official Title:
Implementing the Adapted Parenting Program, SafeCare Kenya, to Reduce Noncommunicable Disease Burden: Building Community Health Volunteers' Capacity to Support Parents With Young Children
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HD112043-01 | NIH | None | https://reporter.nih.gov/quic… | View |