Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya
- Conditions
- ParentingChild Maltreatment
- Interventions
- Behavioral: SafeCare KenyaOther: Care as Usual by Community Health Volunteers
- Registration Number
- NCT06363695
- Lead Sponsor
- Pacific University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 369
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SafeCare Kenya Virtual SafeCare Kenya Community Health Volunteers randomized to SafeCare Kenya will be trained to deliver this program either virtually or in-person. The Community Health Volunteer's families enrolled in the study will be randomized to receive the program either virtually or in-person. For in-person families, the Community Health Volunteer will deliver the session via a virtual platform (e.g., Zoom). The SafeCare Kenya curriculum will be the same in both the virtual and in-person. SafeCare Kenya In-Person SafeCare Kenya Community Health Volunteers randomized to SafeCare Kenya will be trained to deliver this program either virtually or in-person. The Community Health Volunteer's families enrolled in the study will be randomized to receive the program either virtually or in-person. For in-person families, the Community Health Volunteer will deliver the session in the mother's home. The SafeCare Kenya curriculum will be the same in both the virtual and in-person. Care as Usual Care as Usual by Community Health Volunteers Community Health Volunteers will continue their usual services with families. This is typically done on a monthly basis focused on physical health needs of the mother and/or child.
- Primary Outcome Measures
Name Time Method Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months 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 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 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 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in scores on Parenting Stress Index at 6 months Baseline and 6 months The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.
Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months Baseline and 18 months The CBCL uses a 3-point response scale (not true to very true) to assess child internalizing and externalizing symptoms (mental health symptoms)
Change from Baseline in score on Childhood injuries at 18 months Baseline and 18 months Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.
Change from Baseline in score on Childhood injuries at 6 months Baseline and 6 months Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.
Change from Baseline in score on Parent Quality of Life at 18 months Baseline and 18 months The parent will self-report their quality of life using the EQ-5D-5L utility index.
Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months Baseline and 6 months The CBCL uses a 3-point response scale (not true to very true) to assess child internalizing and externalizing symptoms (mental health symptoms)
Change from Baseline in score on Child Quality of Life at 18 months Baseline and 18 months The parent-report version of of the Child Health Utility measure (CHU9D) will assess children's health-related quality of life.
Change from Baseline in scores on Parenting Stress Index at 18 months Baseline and 18 months The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.
Change from Baseline in score on Child Quality of Life at 6 months Baseline and 6 months The parent-report version of of the Child Health Utility measure (CHU9D) will assess children's health-related quality of life.
Change from Baseline in score on Parent Quality of Life at 6 months Baseline and 6 months The parent will self-report their quality of life using the EQ-5D-5L utility index.
Trial Locations
- Locations (1)
Africa Institute of Mental and Brain Health
🇰🇪Nairobi, Kenya