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NCT Number: NCT06363695

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

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.

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Key information

Conditions

Child Maltreatment Parenting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SafeCare

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.

Primary outcomes

  1. Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months

    Time frame: Baseline and 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.

  2. Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months

    Time frame: Baseline and 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.

  3. Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months

    Time frame: Baseline and 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.

  4. Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months

    Time frame: Baseline and 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.

  5. Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months

    Time frame: Baseline and 6 months

    The Quiz will be used to assess knowledge and skills related to the health and safety portions of the SafeCare Kenya intervention.

  6. Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months

    Time frame: Baseline and 18 months

    The Quiz will be used to assess knowledge and skills related to the health and safety portions of the SafeCare Kenya intervention.

  7. Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months

    Time frame: Baseline and 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.

  8. Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months

    Time frame: Baseline and 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.

Secondary outcomes

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

    Time frame: Baseline and 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)

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

    Time frame: Baseline and 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)

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

    Time frame: Baseline and 6 months

    The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.

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

    Time frame: Baseline and 18 months

    The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.

  5. Change from Baseline in score on Childhood injuries at 6 months

    Time frame: Baseline and 6 months

    Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.

  6. Change from Baseline in score on Childhood injuries at 18 months

    Time frame: Baseline and 18 months

    Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.

  7. Change from Baseline in score on Child Quality of Life at 6 months

    Time frame: Baseline and 6 months

    The parent-report version of of the Child Health Utility measure (CHU9D) will assess children's health-related quality of life.

  8. Change from Baseline in score on Child Quality of Life at 18 months

    Time frame: Baseline and 18 months

    The parent-report version of of the Child Health Utility measure (CHU9D) will assess children's health-related quality of life.

  9. Change from Baseline in score on Parent Quality of Life at 6 months

    Time frame: Baseline and 6 months

    The parent will self-report their quality of life using the EQ-5D-5L utility index.

  10. Change from Baseline in score on Parent Quality of Life at 18 months

    Time frame: Baseline and 18 months

    The parent will self-report their quality of life using the EQ-5D-5L utility index.

Other outcomes

  1. Client satisfaction

    Time frame: Up to 12 weeks

    Satisfaction survey of parents' view of SafeCare Kenya services

  2. Provider fidelity

    Time frame: Up to 30 months

    Assessment of Provider's delivery of SafeCare Kenya sessions

  3. Parent Interview

    Time frame: Up to 4 months

    Interview protocol to learn what parents liked and did not like about SafeCare Kenya, changes they suggest, and benefit to future families

  4. Provider Interview

    Time frame: Up to 30 months

    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

  5. Trainer Interview

    Time frame: Up to 30 months

    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

  6. Stakeholder Interview

    Time frame: Up to 30 months

    Interview protocol to learn what stakeholders liked and did not like about SafeCare Kenya and its implementation, along with suggested changes

  7. Readiness Assessment for the Prevention of Child Maltreatment (RAP-CM)

    Time frame: Up to 30 months

    WHO Survey about a country's preparedness to implement a child maltreatment prevention program

Study contacts

Contact information is provided by the study sponsor or research team.

Jenelle R. Shanley, PhD

CONTACT

[email protected]

503-352-6438

Lisa P. Armistead, PhD

CONTACT

[email protected]

404-413-2091

Sponsors and collaborators

Lead sponsor

Pacific University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 12, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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