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Child DevelopmentNCT05796934

Evaluation of the Moments That Matter Program in Kenya

A study testing Moments that Matter (MTM) Program in people with Child Development, run by Harvard School of Public Health (HSPH) at 1 site in Kenya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Child Development
What is being tested?
Moments that Matter (MTM) Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
595 participants
Where
1 siteKenya
Study dates
27 Feb 2023to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Kenya1 site
  • Anglican Church of Kenya Development Services - Nyanza

    Kisumu

Other trials in Kenya

About this study

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.

Read the 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.

Being tested
Moments that Matter (MTM) Program
Keywords
early child development, parenting, Kenya

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moments that Matter (MTM) ProgramBehavioural

    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).

Study groups in NCT05796934
Study groupRoleWhat they receive
Moments that MatterExperimentalThe 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.
Receives: Behavioral: Moments that Matter (MTM) Program
Waitlist-ControlNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 18 months

Secondary outcomes (4)
  1. 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.

    Measured: 18 months

  2. 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.

    Measured: 18 months

  3. 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.

    Measured: 18 months

  4. 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.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start27 Feb 2023
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

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
595 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05796934
Sponsor's protocol ID
IRB22-1670
Status last verified
Apr 2024
First submitted
7 Mar 2023
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jeong J, McCann JK, Hadd AR, Ochuka W, Ochieng M. Effectiveness of the Moments that Matter parenting programme on caregiving practices, family violence, mental health and early child development in Kenya: a cluster-randomised controlled trial. BMJ Glob Health. 2026 Aug 5;11(8):e023335. doi: 10.1136/bmjgh-2025-023335.

    PubMed 42556995
  • Kalam MA, McCann JK, Shakil Z, Gambari A, Ochieng M, Jeong J. Maternal Mental Health and Child Dietary Diversity in Rural Kenya: Findings From a Pooled Analysis of 2 Baseline Studies. Curr Dev Nutr. 2025 Jun 24;9(7):107497. doi: 10.1016/j.cdnut.2025.107497. eCollection 2025 Jul.

    PubMed 40718429

Questions about this trial

What is this clinical trial studying?

A study testing Moments that Matter (MTM) Program in people with Child Development, run by Harvard School of Public Health (HSPH) 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?

The sponsor lists 3 inclusion and 0 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early child development (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05796934, which also lists 2 linked publications.

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 12 Apr 2024.

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