- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06363695
Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya
Implementing the Adapted Parenting Program, SafeCare Kenya, to Reduce Noncommunicable Disease Burden: Building Community Health Volunteers' Capacity to Support Parents With Young Children
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jenelle R. Shanley, PhD
- Phone Number: 503-352-6438
- Email: jshanley@pacificu.edu
Study Contact Backup
- Name: Lisa P. Armistead, PhD
- Phone Number: 404-413-2091
- Email: lparmistead@gsu.edu
Study Locations
-
-
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Nairobi, Kenya
- Recruiting
- Africa Mental Health Research and Training Foundation
-
Contact:
- Victoria Mutiso, PhD
- Phone Number: (254) 202 651 360
- Email: vmutiso@amhf.or.ke
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Contact:
- Christine Musyimi, PhD
- Phone Number: (254) 202 651 360
- Email: christine.musyimi@amhf.or.ke
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Principal Investigator:
- David Ndetei, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Parents Inclusion Criteria:
- 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 Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Care as Usual
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.
|
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.
|
Experimental: SafeCare Kenya In-Person
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.
|
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.
Other Names:
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Experimental: SafeCare Kenya Virtual
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months
Time Frame: 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.
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Baseline and 6 months
|
Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months
Time Frame: 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.
|
Baseline and 18 months
|
Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months
Time Frame: 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.
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Baseline and 6 months
|
Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months
Time Frame: 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.
|
Baseline and 18 months
|
Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months
Time Frame: 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.
|
Baseline and 6 months
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Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months
Time Frame: 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.
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Baseline and 18 months
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Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months
Time Frame: 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.
|
Baseline and 6 months
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Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months
Time Frame: 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.
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Baseline and 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months
Time Frame: 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)
|
Baseline and 6 months
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Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months
Time Frame: Baseline and 18 months
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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
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Change from Baseline in scores on Parenting Stress Index at 6 months
Time Frame: Baseline and 6 months
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The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.
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Baseline and 6 months
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Change from Baseline in scores on Parenting Stress Index at 18 months
Time Frame: Baseline and 18 months
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The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.
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Baseline and 18 months
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Change from Baseline in score on Childhood injuries at 6 months
Time Frame: Baseline and 6 months
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Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.
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Baseline and 6 months
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Change from Baseline in score on Childhood injuries at 18 months
Time Frame: Baseline and 18 months
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Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.
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Baseline and 18 months
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Change from Baseline in score on Child Quality of Life at 6 months
Time Frame: Baseline and 6 months
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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
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Change from Baseline in score on Child Quality of Life at 18 months
Time Frame: 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.
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Baseline and 18 months
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Change from Baseline in score on Parent Quality of Life at 6 months
Time Frame: Baseline and 6 months
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The parent will self-report their quality of life using the EQ-5D-5L utility index.
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Baseline and 6 months
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Change from Baseline in score on Parent Quality of Life at 18 months
Time Frame: Baseline and 18 months
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The parent will self-report their quality of life using the EQ-5D-5L utility index.
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Baseline and 18 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Client satisfaction
Time Frame: Up to 12 weeks
|
Satisfaction survey of parents' view of SafeCare Kenya services
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Up to 12 weeks
|
Provider fidelity
Time Frame: Up to 30 months
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Assessment of Provider's delivery of SafeCare Kenya sessions
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Up to 30 months
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Parent Interview
Time Frame: Up to 4 months
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Interview protocol to learn what parents liked and did not like about SafeCare Kenya, changes they suggest, and benefit to future families
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Up to 4 months
|
Provider Interview
Time Frame: Up to 30 months
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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
Time Frame: Up to 30 months
|
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
Time Frame: Up to 30 months
|
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
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Readiness Assessment for the Prevention of Child Maltreatment (RAP-CM)
Time Frame: Up to 30 months
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WHO Survey about a country's preparedness to implement a child maltreatment prevention program
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Up to 30 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jenelle R. Shanley, PhD, Pacific University
- Principal Investigator: David Ndetei, MD, Africa Mental Health Research and Training Foundation
- Principal Investigator: Lisa P. Armistead, PhD, Georgia State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 131-22
- 1R01HD112043-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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