Child MaltreatmentNCT06363695
Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya
A study testing SafeCare Kenya and Care as Usual by Community Health Volunteers in people with Child Maltreatment and Parenting, run by Pacific University at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment, Parenting
- What is being tested?
- SafeCare Kenya and Care as Usual by Community Health Volunteers
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteKenya
- Study dates
- 14 Mar 2024to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Africa Institute of Mental and Brain Health
Nairobi
Victoria Mutiso, PhD, (254) 202 651 360, vmutiso@amhf.or.ke
Christine Musyimi, PhD, (254) 202 651 360, christine.musyimi@amhf.or.ke
About this study
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
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?
Read more
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.
Read the 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
- Being tested
- SafeCare Kenya, Care as Usual by Community Health Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeCare KenyaBehavioural
Also called SafeCare
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.
Care as Usual by Community Health VolunteersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: SafeCare Kenya |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 18 months
Secondary outcomes (10)
Change from Baseline in score on Child Behavior Checklist (CBCL) at 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)
Measured: Baseline and 6 months
Change from Baseline in score on Child Behavior Checklist (CBCL) at 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)
Measured: Baseline and 18 months
Change from Baseline in scores on Parenting Stress Index at 6 months
The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.
Measured: Baseline and 6 months
Change from Baseline in scores on Parenting Stress Index at 18 months
The PSI includes 36 items assessing parent-child dysfunctional interaction, parental distress and perceptions of a difficult child.
Measured: Baseline and 18 months
Change from Baseline in score on Childhood injuries at 6 months
Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.
Measured: Baseline and 6 months
Change from Baseline in score on Childhood injuries at 18 months
Mothers will report on the type and severity of children's injuries that occurred in the home during the past 6-months.
Measured: Baseline and 18 months
Change from Baseline in score on Child Quality of Life at 6 months
The parent-report version of of the Child Health Utility measure (CHU9D) will assess children's health-related quality of life.
Measured: Baseline and 6 months
Change from Baseline in score on Child Quality of Life at 18 months
The parent-report version of of the Child Health Utility measure (CHU9D) will assess children's health-related quality of life.
Measured: Baseline and 18 months
Change from Baseline in score on Parent Quality of Life at 6 months
The parent will self-report their quality of life using the EQ-5D-5L utility index.
Measured: Baseline and 6 months
Change from Baseline in score on Parent Quality of Life at 18 months
The parent will self-report their quality of life using the EQ-5D-5L utility index.
Measured: Baseline and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start14 Mar 2024
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Georgia State University, Africa Institute of Mental and Brain Health
- Responsible party
- Sponsor
- Investigators
- Jenelle R. Shanley, PhD, Principal investigator, Pacific UniversityDavid Ndetei, MD, Principal investigator, Africa Institute of Mental and Brain HealthLisa P. Armistead, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363695
- Sponsor's protocol ID
- 131-22
- Other IDs
- 1R01HD112043-01
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06363695
- Acronym / sponsor ID
- 131-22
- Conditions
- Child Maltreatment, Parenting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Pacific UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Georgia State University, Africa Institute of Mental and Brain Health
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Care as Usual | Active comparator | Other: Care as Usual by Community Health VolunteersCommunity 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. |
| SafeCare Kenya In-Person | Experimental | Behavioral: SafeCare KenyaCommunity 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. |
| SafeCare Kenya Virtual | Experimental | Behavioral: SafeCare KenyaCommunity 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafeCare KenyaAlso: SafeCareAdapted 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. | Behavioural | SafeCare Kenya In-Person, SafeCare Kenya Virtual |
| Care as Usual by Community Health VolunteersCommunity 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. | Other | Care as Usual |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
10 secondary outcomes
Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months
Time frame: Baseline and 6 months
Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months
Time frame: Baseline and 18 months
Change from Baseline in scores on Parenting Stress Index at 6 months
Time frame: Baseline and 6 months
Change from Baseline in scores on Parenting Stress Index at 18 months
Time frame: Baseline and 18 months
Change from Baseline in score on Childhood injuries at 6 months
Time frame: Baseline and 6 months
Change from Baseline in score on Childhood injuries at 18 months
Time frame: Baseline and 18 months
Change from Baseline in score on Child Quality of Life at 6 months
Time frame: Baseline and 6 months
Change from Baseline in score on Child Quality of Life at 18 months
Time frame: Baseline and 18 months
Change from Baseline in score on Parent Quality of Life at 6 months
Time frame: Baseline and 6 months
Change from Baseline in score on Parent Quality of Life at 18 months
Time frame: Baseline and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenelle R. Shanley, PhD principal investigator
Pacific University
David Ndetei, MD principal investigator
Africa Institute of Mental and Brain Health
Lisa P. Armistead, PhD principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeCare Kenya and Care as Usual by Community Health Volunteers in people with Child Maltreatment and Parenting, run by Pacific University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenelle R. Shanley, PhD (503-352-6438, jshanley@pacificu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months (time frame: Baseline and 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.