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

Pacific University

Status: Enrolling

Conditions: Parenting; Child Maltreatment

Treatments: Other: Care as Usual by Community Health Volunteers; Behavioral: SafeCare Kenya

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06363695

131-22

1R01HD112043-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 369 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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369 participants in 3 patient groups

Care as Usual

Active Comparator group

Description:

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.

Treatment:

Other: Care as Usual by Community Health Volunteers

SafeCare Kenya In-Person

Experimental group

Description:

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.

Treatment:

Behavioral: SafeCare Kenya

SafeCare Kenya Virtual

Experimental group

Description:

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.

Treatment:

Behavioral: SafeCare Kenya