Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya

Parenting Clinical Trial

Official title:

Implementing the Adapted Parenting Program, SafeCare Kenya, to Reduce Noncommunicable Disease Burden: Building Community Health Volunteers' Capacity to Support Parents With Young Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363695
• Other study ID #: 131-22
• Secondary ID: 1R01HD112043-01
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: May 2028

Study information

• Verified date: April 2024
• Source: Pacific University
• Contact: Jenelle R. Shanley, PhD
• Phone: 503-352-6438
• Email: jshanley[@]pacificu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 369
• Est. completion date: May 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Maltreatment
• Parenting

Intervention

Behavioral:
• SafeCare Kenya
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:
• Care as Usual by Community Health Volunteers
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.

Locations

Country	Name	City	State
Kenya	Africa Mental Health Research and Training Foundation	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
Pacific University	Africa Mental Health Research and Training Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Georgia State University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client satisfaction	Satisfaction survey of parents' view of SafeCare Kenya services	Up to 12 weeks
Other	Provider fidelity	Assessment of Provider's delivery of SafeCare Kenya sessions	Up to 30 months
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.	Baseline and 6 months
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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)	Baseline and 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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