- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05796934
Evaluation of the Moments That Matter Program in Kenya
April 10, 2024 updated by: Joshua Jeong, Harvard School of Public Health (HSPH)
This cluster-randomized trial aims to evaluate the impact of the Moments That Matter® (MTM) Program on early child development and caregiving outcomes in two selected counties in western Kenya.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Approximately 43% of children under-5 are at risk of not attaining their developmental potential.
Parenting interventions are recommended for improving early childhood development during the earliest years of life.
However, there is limited evidence regarding the delivery and effectiveness of parenting interventions to promote early child development outcomes in Kenya specifically.
This cluster-randomized trial aims to evaluate the effectiveness of the Moments That Matter® (MTM) Program on early child development and caregiving outcomes in two selected counties in western Kenya.
The MTM Program will be implemented by the Anglican Church of Kenya Development Services - Nyanza (ADS-Nyanza), a faith-based organization focused on supporting integrated community-based programs to support the health, wellbeing, and development of the most vulnerable children and families.
Various stakeholders - including community volunteers, faith leaders, and ECD committees - will be mobilized and trained to deliver nurturing care and ECD services over an 18-month program period.
This trial will enroll primary caregivers of children 0-18 months of age and longitudinally follow the study cohort to ultimately compare changes in early child development and caregiving outcomes between the intervention and waitlist-control study arms.
In addition to the impact evaluation, a qualitative implementation evaluation will be conducted to assess quality of delivery, identify factors that influence program effectiveness, and determine program potential for sustainability and scale-up.
Study Type
Interventional
Enrollment (Actual)
595
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joshua Jeong, ScD
- Phone Number: 6174325144
- Email: joshua.jeong@hsph.harvard.edu
Study Locations
-
-
-
Kisumu, Kenya
- Anglican Church of Kenya Development Services - Nyanza
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Primary caregiver (parent or legal guardian) to a child aged 0-18 months
- Resides in a village selected into the research study
- Caregiver provides informed consent on behalf of both themself and the child to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moments that Matter
The intervention group will receive the Moments that Matter (MTM) program, which will involve monthly peer group sessions and monthly home visits that are delivered by ECD promoters over an 18-month program duration, training of faith leaders, and the formation of ECD committees at the community-level.
|
MTM aims to empower caregivers, enhance nurturing care practices, and ultimately improve early child development (ECD).
MTM will be targeted to primary caregivers of children aged 0-3 years and implemented over an 18 month period.
The primary program delivery agent will be local volunteers ("ECD promoters") who will facilitate monthly peer group sessions and conduct monthly home visits to participants residing in their village.
The MTM curriculum covers topics relating to responsive caregiving, early learning, and child security & safety, and gender equality.
Faith leaders will also be trained to promote nurturing care and ECD within their sermons and Bible study groups.
ECD committees will be also formed among leaders across various sectors (e.g., health, education, faith institutions) to promote nurturing care and ECD at the community level and coordinate MTM activities with program staff, delivery agents, and other existing service providers (e.g., community health volunteers).
|
No Intervention: Waitlist-Control
The control group will not immediately receive the MTM program but instead the standard of care services (e.g., those provided by community health volunteers which are primarily focused on maternal and child health and nutrition).
After follow-up assessments are completed for the trial, then villages in the control group will receive the MTM program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early child development
Time Frame: 18 months
|
Child development measured using the Caregiver Report of Early Development Index (CREDI) long form version. Scores will be analyzed separately by developmental domain: motor, language, cognitive, and socioemotional development.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver stimulation practices
Time Frame: 18 months
|
Caregiver stimulation practices reported as the number of developmentally-enriching activities that the primary caregiver engaged with the young child (e.g.
singing, telling stories).
Activities adapted from the Family Care Indicators.
A total score will be calculated with higher scores indicated more engagement in stimulation activities.
|
18 months
|
Home learning materials
Time Frame: 18 months
|
Caregiver-reported index of the variety of play and learning materials in the household for child (e.g., home-made toys, store-bought toys, household items).
Items adapted from the Family Care Indicators.
A total score will be calculated with higher scores indicated more types of home learning materials available for child.
|
18 months
|
Caregiver disciplinary practices
Time Frame: 18 months
|
Caregiver disciplinary practices reported with respect to both harsh punishment (e.g., shook the child, shouted at child) and positive disciplinary practices (e.g., explained why the behavior was wrong) used by the primary caregiver towards the child.
Items adapted from Child Discipline Module of Multiple Indicator Cluster Survey.
Separate indicators will be created for use of any harsh disciplinary practices or any positive disciplinary practices.
|
18 months
|
Parenting stress
Time Frame: 18 months
|
Parenting distress reported by the primary caregiver using the Parenting Stress Index-Short Form, Parental Distress subscale.
Higher total scores indicate greater parenting distress.
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant and young child feeding (IYCF) practices
Time Frame: 18 months
|
IYCF practices including self-reported breastfeeding and exclusive breastfeeding practices, child dietary diversity score (24 hours), and responsive feeding.
Child dietary diversity defined as the number of food groups the child consumed in previous 24 hours based on WHO guidelines.
Responsive feeding assessed using a caregiver-reported measure for the style of interaction between primary caregiver and child during mealtime (e.g., talking to child during mealtimes, allowing the child to feed him/herself and explore their food).
Higher scores indicate more caregiver responsive feeding behaviors.
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18 months
|
Care-seeking for child illness
Time Frame: 18 months
|
Indicator for whether primary caregiver sought advice or treatment from appropriate health facility or provider in the event of recent child illness (e.g., cough, fever) based on standard indicator used in UNICEF's Multiple Indicator Cluster Surveys.
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18 months
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Male caregiver involvement
Time Frame: 18 months
|
Male caregiver involvement reported by the primary caregivers regarding the number of childcare and household activities performed by the primary male caregiver to support the young child, female partner, or family more broadly (e.g., bathing child, providing money to partner, washing dishes/clothes).
Measure developed by authors for this study.
Higher scores indicate greater male caregiver involvement.
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18 months
|
Gender attitudes
Time Frame: 18 months
|
Gender attitudes measured as the primary caregiver's perceptions regarding gender norms and caregiving roles within a household.
Items pertain to power dynamics in intimate partner relationships and division of childcare and household responsibilities.
Higher scores indicate more gender-equitable attitudes.
|
18 months
|
Social support
Time Frame: 18 months
|
Social support reported by the primary caregiver using the Multidimensional Scale of Perceived Social Support.
Higher scores indicate greater perceived social support.
|
18 months
|
Birth registration
Time Frame: 18 months
|
Indicator for whether child's birth was reported by primary caregiver as registered with civil authorities based on standard indicator used in UNICEF's Multiple Indicator Cluster Surveys.
|
18 months
|
Intimate partner violence
Time Frame: 18 months
|
Indicator for whether female primary caregiver reported of any form of intimate partner violence victimization (e.g., physical, emotional) by a male partner using an adapted version of the domestic violence questionnaire from the Demographic and Health Surveys.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joshua Jeong, ScD, Harvard School of Public Health (HSPH)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2023
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
March 7, 2023
First Submitted That Met QC Criteria
April 1, 2023
First Posted (Actual)
April 4, 2023
Study Record Updates
Last Update Posted (Actual)
April 12, 2024
Last Update Submitted That Met QC Criteria
April 10, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB22-1670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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