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

NCT06363695 | Recruiting

• 2 other identifiers: 131-221R01HD112043-01
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Maltreatment; Parenting

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months

  Baseline and 6 months

• Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months

  Baseline and 18 months

• Change from Baseline in scores on Parenting Stress Index at 6 months

  Baseline and 6 months

• Change from Baseline in scores on Parenting Stress Index at 18 months

  Baseline and 18 months

• Change from Baseline in score on Childhood injuries at 6 months

  Baseline and 6 months

Other Outcomes (7)

• Client satisfaction

  Up to 12 weeks

• Provider fidelity

  Up to 30 months

• Parent Interview

  Up to 4 months

Study Arms (3)

Care as Usual

ACTIVE COMPARATOR

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.

Other: Care as Usual by Community Health Volunteers

SafeCare Kenya In-Person

EXPERIMENTAL

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.

Behavioral: SafeCare Kenya

SafeCare Kenya Virtual

EXPERIMENTAL

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.

Behavioral: SafeCare Kenya

Interventions

SafeCare Kenya 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.

Also known as: SafeCare

SafeCare Kenya In-Person; SafeCare Kenya Virtual

Care as Usual by Community Health Volunteers 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.

Care as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• younger than 18 years old
• unable to participate in English or Swahili
• does not own smart phone to participate in virtual sessions.
• 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
• 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
• years or older
• able to participate in English and Swahili
• trained as a SafeCare trainer

Sponsors & Collaborators

• Pacific University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Georgia State University: collaborator
• Africa Institute of Mental and Brain Health: collaborator

Study Sites (1)

Africa Institute of Mental and Brain Health

Nairobi, Kenya

RECRUITING

Study Officials

• Jenelle R. Shanley, PhD

  Pacific University

  PRINCIPAL INVESTIGATOR

• David Ndetei, MD

  Africa Institute of Mental and Brain Health

  PRINCIPAL INVESTIGATOR

• Lisa P. Armistead, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenelle R. Shanley, PhD

CONTACT

503-352-6438; jshanley@pacificu.edu

Lisa P. Armistead, PhD

CONTACT

404-413-2091; lparmistead@gsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 12, 2024
• Study Start: March 14, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 18, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)