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

NCT ID: NCT06363695

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2028-05-31

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.

Conditions

Child Maltreatment; Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Care as Usual by Community Health Volunteers

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

SafeCare Kenya

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

SafeCare Kenya

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

SafeCare

Eligibility Criteria

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.

• 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

• 18 years or older
• able to participate in English and Swahili
• trained as a SafeCare trainer

• 18 years or older
• able to participate in English
• involved in the project as a stakeholder

Exclusion Criteria

• younger than 18 years old
• unable to participate in English or Swahili
• does not own smart phone to participate in virtual sessions.

• 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

• younger than 18 years old
• not able to participate in English and Swahili
• not trained as a SafeCare Trainer

• younger than 18 years old
• not able to participate in English
• not a stakeholder for this project

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Georgia State University

OTHER

Sponsor Role: collaborator

Africa Institute of Mental and Brain Health

UNKNOWN

Sponsor Role: collaborator

Pacific University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenelle R. Shanley, PhD

Role: PRINCIPAL_INVESTIGATOR

Pacific University

David Ndetei, MD

Role: PRINCIPAL_INVESTIGATOR

Africa Institute of Mental and Brain Health

Lisa P. Armistead, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

Africa Institute of Mental and Brain Health

Nairobi, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

Jenelle R. Shanley, PhD

Role: CONTACT

jshanley@pacificu.edu

503-352-6438

Lisa P. Armistead, PhD

Role: CONTACT

lparmistead@gsu.edu

404-413-2091

Facility Contacts

Victoria Mutiso, PhD

Role: primary

vmutiso@amhf.or.ke

(254) 202 651 360

Christine Musyimi, PhD

Role: backup

christine.musyimi@amhf.or.ke

(254) 202 651 360

Other Identifiers

1R01HD112043-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

131-22

Identifier Type: -

Identifier Source: org_study_id