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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
595

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Kenya
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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).
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
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.
18 months
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.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard School of Public Health (HSPH)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Anglican Church of Kenya Development Services - Nyanza (ADS-Nyanza)
Episcopal Relief & Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings