Implementing the Adapted Parenting Program, SafeCare Kenya, to Reduce Noncommunicable Disease Burden: Building Community Health Volunteers' Capacity to Support Parents With Young Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months
时间窗: Baseline and 6 months
The Quiz will be used to assess knowledge and skills related to the health and safety portions of the SafeCare Kenya intervention.
Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months
时间窗: Baseline and 6 months
The SafeCare Kenya form, cPAT, will be used to assess positive parent interaction skills. It is an observation of the 10 targeted skills in the SCK program. The assessor will virtually observe 1 play interaction. They rate parents using a minus when no skills present, check when some, and check plus when all aspects of the skill are present.
Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months
时间窗: Baseline and 6 months
21 items assess a range of positive parenting practices, such as praise/rewards, planning for transitions, and providing choices among other practices. Items are summed to create an overall parent-child interaction score.
Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months
时间窗: Baseline and 6 months
The BCAPI assesses parents' potential to engage in child maltreatment related behaviors. The 24 risk scale items are summed to create a total abuse potential score, with higher scores indicating higher abuse potential.
Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months
时间窗: Baseline and 18 months
The BCAPI assesses parents' potential to engage in child maltreatment related behaviors. The 24 risk scale items are summed to create a total abuse potential score, with higher scores indicating higher abuse potential.
Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months
时间窗: Baseline and 18 months
The Quiz will be used to assess knowledge and skills related to the health and safety portions of the SafeCare Kenya intervention.
Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months
时间窗: Baseline and 18 months
The SafeCare Kenya form, cPAT, will be used to assess positive parent interaction skills. It is an observation of the 10 targeted skills in the SCK program. The assessor will virtually observe 1 play interaction. They rate parents using a minus when no skills present, check when some, and check plus when all aspects of the skill are present.
Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months
时间窗: Baseline and 18 months
21 items assess a range of positive parenting practices, such as praise/rewards, planning for transitions, and providing choices among other practices. Items are summed to create an overall parent-child interaction score.
次要结局
- Change from Baseline in scores on Parenting Stress Index at 6 months(Baseline and 6 months)
- Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months(Baseline and 18 months)
- Change from Baseline in score on Childhood injuries at 18 months(Baseline and 18 months)
- Change from Baseline in score on Childhood injuries at 6 months(Baseline and 6 months)
- Change from Baseline in score on Parent Quality of Life at 18 months(Baseline and 18 months)
- Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months(Baseline and 6 months)
- Change from Baseline in score on Child Quality of Life at 18 months(Baseline and 18 months)
- Change from Baseline in scores on Parenting Stress Index at 18 months(Baseline and 18 months)
- Change from Baseline in score on Child Quality of Life at 6 months(Baseline and 6 months)
- Change from Baseline in score on Parent Quality of Life at 6 months(Baseline and 6 months)