Clinical trial NCT06363695: Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Maltreatment
Parenting
Lead sponsor: Pacific University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Georgia State University
name: Africa Institute of Mental and Brain Health
First posted: 2024-04-12
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months
timeFrame: Baseline and 18 months
measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months
timeFrame: Baseline and 18 months
measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months
timeFrame: Baseline and 18 months
measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months
timeFrame: Baseline and 18 months
Secondary outcomes:
measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months
timeFrame: Baseline and 18 months
measure: Change from Baseline in scores on Parenting Stress Index at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in scores on Parenting Stress Index at 18 months
timeFrame: Baseline and 18 months
measure: Change from Baseline in score on Childhood injuries at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in score on Childhood injuries at 18 months
timeFrame: Baseline and 18 months
measure: Change from Baseline in score on Child Quality of Life at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in score on Child Quality of Life at 18 months
timeFrame: Baseline and 18 months
measure: Change from Baseline in score on Parent Quality of Life at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in score on Parent Quality of Life at 18 months
timeFrame: Baseline and 18 months
Other outcomes:
measure: Client satisfaction
timeFrame: Up to 12 weeks
measure: Provider fidelity
timeFrame: Up to 30 months
measure: Parent Interview
timeFrame: Up to 4 months
measure: Provider Interview
timeFrame: Up to 30 months
measure: Trainer Interview
timeFrame: Up to 30 months
measure: Stakeholder Interview
timeFrame: Up to 30 months
measure: Readiness Assessment for the Prevention of Child Maltreatment (RAP-CM)
timeFrame: Up to 30 months
Locations:
city: Nairobi
country: Kenya
facility: Africa Institute of Mental and Brain Health
Study officials:
affiliation: Pacific University
name: Jenelle R. Shanley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Africa Institute of Mental and Brain Health
name: David Ndetei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia State University
name: Lisa P. Armistead, PhD
role: PRINCIPAL_INVESTIGATOR
References: