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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Child Development
- 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 group | Role | What they receive |
|---|---|---|
| Moments that Matter | Experimental | 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. Receives: Behavioral: Moments that Matter (MTM) Program |
| Waitlist-Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted4 Apr 2023
- Study start27 Feb 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Anglican Church of Kenya Development Services - Nyanza (ADS-Nyanza), Episcopal Relief & Development
- Responsible party
- Principal investigator, Joshua Jeong, Harvard School of Public Health (HSPH)
- Investigators
- Joshua Jeong, ScD, Principal investigator, Harvard School of Public Health (HSPH)
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 42556995Kalam 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Moments That Matter Program in Kenya
- ClinicalTrials.gov ID
- NCT05796934
- Acronym / sponsor ID
- IRB22-1670
- Conditions
- Child Development
- Keywords
- early child development, parenting, Kenya
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 595 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Anglican Church of Kenya Development Services - Nyanza (ADS-Nyanza), Episcopal Relief & Development
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moments that Matter | Experimental | Behavioral: Moments that Matter (MTM) ProgramThe 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. |
| Waitlist-Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moments that Matter (MTM) ProgramMTM 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). | Behavioural | Moments that Matter |
Primary outcome
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.
4 secondary outcomes
Caregiver stimulation practices
Time frame: 18 months
Home learning materials
Time frame: 18 months
Caregiver disciplinary practices
Time frame: 18 months
Parenting stress
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 42556995Jeong 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.
- Derived from this study: PubMed 40718429Kalam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Jeong, ScD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
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.