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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD112043-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Georgia State University | OTHER |
| Africa Institute of Mental and Brain Health | UNKNOWN |
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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:
Mothers will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care as Usual | Active Comparator | 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. |
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| SafeCare Kenya In-Person | Experimental | 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. |
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| SafeCare Kenya Virtual | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SafeCare Kenya | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and 6 months |
| Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Client satisfaction | Satisfaction survey of parents' view of SafeCare Kenya services | Up to 12 weeks |
| Provider fidelity | Assessment of Provider's delivery of SafeCare Kenya sessions |
Parents Inclusion Criteria:
Parent Exclusion Criteria:
CHV Inclusion Criteria:
CHV Exclusion Criteria:
Trainer Inclusion Criteria:
Trainer Exclusion Criteria:
Stakeholder Inclusion Criteria:
Stakeholder Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenelle R. Shanley, PhD | Contact | 503-352-6438 | jshanley@pacificu.edu | |
| Lisa P. Armistead, PhD | Contact | 404-413-2091 | lparmistead@gsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jenelle R. Shanley, PhD | Pacific University | Principal Investigator |
| David Ndetei, MD | Africa Institute of Mental and Brain Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Africa Institute of Mental and Brain Health | Recruiting | Nairobi | Kenya |
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| Care as Usual by Community Health Volunteers | Other | 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. |
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| 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. | 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. | 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. | 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) |
| 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. | 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. | 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. | 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. | 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. | Baseline and 6 months |
| 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. | 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. | 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. | Baseline and 18 months |
| Up to 30 months |
| Parent Interview | Interview protocol to learn what parents liked and did not like about SafeCare Kenya, changes they suggest, and benefit to future families | Up to 4 months |
| Provider Interview | Interview protocol to learn what providers liked and did not like about SafeCare Kenya, changes they suggest, benefit to future families, value and challenges with delivery modalities, value and challenges with training and coaching support | Up to 30 months |
| Trainer Interview | Interview protocol to learn what trainers liked and did not like about SafeCare Kenya, changes they suggest, benefit to future families, value and challenges with delivery modalities, value and challenges with training and coaching | Up to 30 months |
| Stakeholder Interview | Interview protocol to learn what stakeholders liked and did not like about SafeCare Kenya and its implementation, along with suggested changes | Up to 30 months |
| Readiness Assessment for the Prevention of Child Maltreatment (RAP-CM) | WHO Survey about a country's preparedness to implement a child maltreatment prevention program | Up to 30 months |
| Lisa P. Armistead, PhD |
| Georgia State University |
| Principal Investigator |