Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPacific University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
younger than 18 years old
unable to participate in English or Swahili
does not own smart phone to participate in virtual sessions.
18 years or older
Trial design
Design model
Parallel
Treatments tested in this trial
SafeCare Kenya
BehavioralAdapted 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 Volunteers
Other interventionCommunity 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.
Treatment groups
369 Participants
are divided into 3 treatment groupsGroup A: Care as UsualActive comparator 1 intervention
Group B: SafeCare Kenya In-PersonExperimental treatment 1 intervention
Group C: SafeCare Kenya VirtualExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 6 months2
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.
Time frame
Baseline and 18 months3
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.
Time frame
Baseline and 6 months4
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.
Time frame
Baseline and 18 monthsSecondary outcomes
1
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)
Time frame
Baseline and 6 months2
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)
Time frame
Baseline and 18 months3
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.
Time frame
Baseline and 6 months4
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.
Time frame
Baseline and 18 monthsOther outcomes
1
Client satisfaction
Satisfaction survey of parents' view of SafeCare Kenya services
Time frame
Up to 12 weeks2
Provider fidelity
Assessment of Provider's delivery of SafeCare Kenya sessions
Time frame
Up to 30 months3
Parent Interview
Interview protocol to learn what parents liked and did not like about SafeCare Kenya, changes they suggest, and benefit to future families
Time frame
Up to 4 months4
Provider Interview
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
Time frame
Up to 30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pacific University
Lead sponsor
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
Source ClinicalTrials.gov