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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
369
Adapted from SafeCare, this is a strengths-based program for parents with children ages 18 months through age 5, teaching parents skills and knowledge in three areas: 1) parent-child interactions, 2) child health, and 3) home safety.
Community Health Volunteers support families with children up to age 5 around the physical health needs of family members, including delivering key health messages (e.g., importance of immunizations); treating minor injuries and illnesses; identifying/treating/referring common childhood illnesses (e.g., diarrhea, malaria); conducting home visits to evaluate the home environment and discuss improvements; and encouraging care at home and appropriate health seeking behaviors. These support services are not highly structured but rather tailored to the needs of each family.
Africa Institute of Mental and Brain Health
Nairobi, Kenya
RECRUITINGChange from Baseline in score on Child Planned Activities Training (cPAT) at 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.
Time frame: Baseline and 6 months
Change from Baseline in score on Child Planned Activities Training (cPAT) at 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.
Time frame: Baseline and 18 months
Change from Baseline in scores on Parenting Young Children (PARYC) at 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.
Time frame: Baseline and 6 months
Change from Baseline in scores on Parenting Young Children (PARYC) at 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.
Time frame: Baseline and 18 months
Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months
The Quiz will be used to assess knowledge and skills related to the health and safety portions of the SafeCare Kenya intervention.
Time frame: Baseline and 6 months
Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months
The Quiz will be used to assess knowledge and skills related to the health and safety portions of the SafeCare Kenya intervention.
Time frame: Baseline and 18 months
Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 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.
Time frame: Baseline and 6 months
Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 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.
Time frame: Baseline and 18 months
Change from Baseline in score on Child Behavior Checklist (CBCL) at 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)
Time frame: Baseline and 6 months
Change from Baseline in score on Child Behavior Checklist (CBCL) at 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)
Time frame: Baseline and 18 months
Change from Baseline in scores on Parenting Stress Index at 6 months
The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.
Time frame: Baseline and 6 months
Change from Baseline in scores on Parenting Stress Index at 18 months
The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.
Time frame: Baseline and 18 months
Change from Baseline in score on Childhood injuries at 6 months
Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.
Time frame: Baseline and 6 months
Change from Baseline in score on Childhood injuries at 18 months
Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.
Time frame: Baseline and 18 months
Change from Baseline in score on Child Quality of Life at 6 months
The parent-report version of of the Child Health Utility measure (CHU9D) will assess children's health-related quality of life.
Time frame: Baseline and 6 months
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Change from Baseline in score on Child Quality of Life at 18 months
The parent-report version of of the Child Health Utility measure (CHU9D) will assess children's health-related quality of life.
Time frame: Baseline and 18 months
Change from Baseline in score on Parent Quality of Life at 6 months
The parent will self-report their quality of life using the EQ-5D-5L utility index.
Time frame: Baseline and 6 months
Change from Baseline in score on Parent Quality of Life at 18 months
The parent will self-report their quality of life using the EQ-5D-5L utility index.
Time frame: Baseline and 18 months