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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05796934
Other study ID # IRB22-1670
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 27, 2023
Est. completion date May 31, 2025

Study information

Verified date April 2024
Source Harvard School of Public Health (HSPH)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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 MatterĀ® (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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 595
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Moments that Matter (MTM) Program
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).

Locations

Country Name City State
Kenya Anglican Church of Kenya Development Services - Nyanza Kisumu

Sponsors (3)

Lead Sponsor Collaborator
Harvard School of Public Health (HSPH) Anglican Church of Kenya Development Services - Nyanza (ADS-Nyanza), Episcopal Relief & Development

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Other Infant and young child feeding (IYCF) practices 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. 18 months
Other Care-seeking for child illness 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. 18 months
Other Male caregiver involvement 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. 18 months
Other Gender attitudes 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
Other Social support Social support reported by the primary caregiver using the Multidimensional Scale of Perceived Social Support. Higher scores indicate greater perceived social support. 18 months
Other Birth registration 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
Other Intimate partner violence 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
Primary Early child development 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 Caregiver stimulation practices 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
Secondary Home learning materials 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
Secondary Caregiver disciplinary practices 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
Secondary Parenting stress 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
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