Child DevelopmentNCT06140017
Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya
A study testing Msingi Bora responsive parenting and family wellbeing program in people with Child Development and Child Behavior, run by University of Southern California at 1 site in Kenya.
Trial summary
An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Read more about this study
- Who is it for?
- Ages 4 months and olderHealthy volunteers can take part
- Conditions the study is for
- Child Development, Child Behavior, Language, Child
- What is being tested?
- Msingi Bora responsive parenting and family wellbeing program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteKenya
- Study dates
- 24 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- mothers or other primary caretakers aged 18 years or older
- able to read English or Swahili at a level sufficient to understand the SMS messages
- with a child aged 6-18 months at recruitment without signs of severe mental or physical impairments (youngest child if more than one eligible for a given mother)
Who cannot join
- mothers/households without children
- households with children that are outside the age range of 6-18 months at baseline
- mothers who lack basic literacy so as not to understand SMS messages
Trial locations and contacts
1 site in 1 country.
About this study
An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are a) still too expensive to implement at scale in low-resource and rural settings, and b) their early impacts tend to fade over time in the absence of continued support. New ways to deliver effective ECD parenting interventions are sorely needed that are both low-cost to be potentially scalable, while also able to sustain impacts long-term.
The rapid growth and low cost of mobile communications in LMIC settings presents a potentially promising solution to the competing problems of scalability and sustainability. Yet there is no rigorous research on mobile-health (mHealth) interventions for ECD outcomes in LMIC settings. Study investigators recently showed that an 8-month ECD parenting intervention featuring fortnightly group meetings delivered by Community Health Workers (CHWs) from Kenya's rural health care system significantly improved child cognitive, language, and socioemotional development as well as parenting practices, and a group-based delivery model was more cost-effective than previous ECD interventions. Yet it is still too expensive for scaling in a rural LMIC setting such as rural Kenya, particularly if interventions are needed that can be extended for longer periods of time to increase their ability to sustain impacts. This study will experimentally test a traditional in-person group-based delivery model for an ECD parenting intervention against an mHealth-based delivery model that partially substitutes remote delivery for in-person group meetings. The relative effectiveness and costs of this hybrid-delivery model will be assessed against a purely in-person group model, and the interventions will extend over two years to increase their ability to sustain changes in child outcomes longer-term. The evaluation design is a clustered Randomized Control Trial across 90 CHWs and their associated villages and 1200 households. The central hypothesis is that a hybrid ECD intervention will be lower cost, but remote delivery may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program.
- Conditions
- Child Development, Child Behavior, Language, Child
- Being tested
- Msingi Bora responsive parenting and family wellbeing program
- Medical subject headings
- Child Behavior, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Msingi Bora responsive parenting and family wellbeing programBehavioural
Msingi Bora's structured curriculum of 16 biweekly sessions and monthly boosters thereafter are organized around five key messages: love and respect within the family, responsive talk, responsive play, hygiene, and nutrition.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Group Delivery | Active comparator | A total of 30 villages will receive a traditional in-person group-based delivery for Msingi Bora, an ECD parenting intervention featuring 16 biweekly village sessions over 8 months, followed by monthly "booster" meetings for 16 additional months. Sessions will be delivered within by existing village Community Health Volunteers (CHVs). Mothers and children will be invited to attend a total of 32 in-person sessions of roughly 1.5-2 hours apiece over 24 months. Receives: Behavioral: Msingi Bora responsive parenting and family wellbeing program |
| Hybrid mHealth/In-Person Group Delivery | Experimental | 30 CHVs will deliver a hybrid intervention that combines in-person meetings with remote delivery for Msingi Bora, an ECD parenting intervention. Mother-child dyads will be invited to participate in roughly 10 in-person group sessions in the first 8 months, followed by 5 in-person group sessions over the next 16 months. For those sessions delivered remotely, mothers will receive videos demonstrating the practices, SMS messages, be invited to participate in group SMS/WhatsApp chats with the CHV and other village mothers, and periodic phone calls. The project will provide smartphones to all mothers assigned to this arm for facilitation. Receives: Behavioral: Msingi Bora responsive parenting and family wellbeing program |
| Control Group | No intervention | Mothers and children in 30 villages will not receive any intervention beyond information about child feeding during a baseline survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Cognitive Development - Bayley
The Bayley Scales of Infant Development 3rd edition (Bayley's III) is validated in African settings and provides measures for all dimensions of child development up to 42 months of age. The official age-standardized cognitive scale has a 0-19 range with higher values denoting better scores.
Measured: Midline/8-month survey, Endline/24-month survey
Secondary outcomes (1)
Parenting Behaviors
The Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory has four versions: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the endline/month 8 survey the HOME scale scores will range from 0-45, with higher scores denoting better outcomes.
Measured: Midline/8-month survey, Endline/24-month survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Oct 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Safe Water and AIDS Project
- Responsible party
- Principal investigator, Italo Lopez Garcia, University of Southern California
- Investigators
- Italo Lopez Garcia, PhD, Principal investigator, University of Southern CaliforniaJill E Luoto, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140017
- Sponsor's protocol ID
- R01HD107116
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will be stripped of identifiers prior to release for sharing. In no way will there be the possibility of deductive disclosure of subjects. We will make the data without identifiers publicly available in accordance with NIH policy by posting it in de-identified form to the Inter-university Consortium for Political and Social Research (ICPSR) data bank. More information on their data confidentiality practices can be found at: https://www.icpsr.umich.edu/web/pages/datamanagement/confidentiality/index.html.
Publications
Garcia IL, Luoto J, Aboud F, Jervis P, Mwoma T, Alu E, Odhiambo A. In-person versus remote (mHealth) delivery for a responsive parenting intervention in rural Kenya: a cluster randomized controlled trial. BMC Public Health. 2024 Sep 5;24(1):2421. doi: 10.1186/s12889-024-19828-5.
PubMed 39237936Garcia IL, Luoto J, Aboud F, Jervis P, Mwoma T, Alu E, Odhiambo A. In-person versus remote (mHealth) delivery for a responsive parenting intervention in rural Kenya: A cluster randomized controlled trial. Res Sq [Preprint]. 2024 Aug 16:rs.3.rs-4733054. doi: 10.21203/rs.3.rs-4733054/v1.
PubMed 39184097
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya
- ClinicalTrials.gov ID
- NCT06140017
- Acronym / sponsor ID
- R01HD107116
- Conditions
- Child Development, Child Behavior, Language, Child
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Safe Water and AIDS Project
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 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.
An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are a) still too expensive to implement at scale in low-resource and rural settings, and b) their early impacts tend to fade over time in the absence of continued support. New ways to deliver effective ECD parenting interventions are sorely needed that are both low-cost to be potentially scalable, while also able to sustain impacts long-term.
The rapid growth and low cost of mobile communications in LMIC settings presents a potentially promising solution to the competing problems of scalability and sustainability. Yet there is no rigorous research on mobile-health (mHealth) interventions for ECD outcomes in LMIC settings. Study investigators recently showed that an 8-month ECD parenting intervention featuring fortnightly group meetings delivered by Community Health Workers (CHWs) from Kenya's rural health care system significantly improved child cognitive, language, and socioemotional development as well as parenting practices, and a group-based delivery model was more cost-effective than previous ECD interventions. Yet it is still too expensive for scaling in a rural LMIC setting such as rural Kenya, particularly if interventions are needed that can be extended for longer periods of time to increase their ability to sustain impacts. This study will experimentally test a traditional in-person group-based delivery model for an ECD parenting intervention against an mHealth-based delivery model that partially substitutes remote delivery for in-person group meetings. The relative effectiveness and costs of this hybrid-delivery model will be assessed against a purely in-person group model, and the interventions will extend over two years to increase their ability to sustain changes in child outcomes longer-term. The evaluation design is a clustered Randomized Control Trial across 90 CHWs and their associated villages and 1200 households. The central hypothesis is that a hybrid ECD intervention will be lower cost, but remote delivery may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-Person Group Delivery | Active comparator | Behavioral: Msingi Bora responsive parenting and family wellbeing programA total of 30 villages will receive a traditional in-person group-based delivery for Msingi Bora, an ECD parenting intervention featuring 16 biweekly village sessions over 8 months, followed by monthly "booster" meetings for 16 additional months. Sessions will be delivered within by existing village Community Health Volunteers (CHVs). Mothers and children will be invited to attend a total of 32 in-person sessions of roughly 1.5-2 hours apiece over 24 months. |
| Hybrid mHealth/In-Person Group Delivery | Experimental | Behavioral: Msingi Bora responsive parenting and family wellbeing program30 CHVs will deliver a hybrid intervention that combines in-person meetings with remote delivery for Msingi Bora, an ECD parenting intervention. Mother-child dyads will be invited to participate in roughly 10 in-person group sessions in the first 8 months, followed by 5 in-person group sessions over the next 16 months. For those sessions delivered remotely, mothers will receive videos demonstrating the practices, SMS messages, be invited to participate in group SMS/WhatsApp chats with the CHV and other village mothers, and periodic phone calls. The project will provide smartphones to all mothers assigned to this arm for facilitation. |
| Control Group | No intervention | –Mothers and children in 30 villages will not receive any intervention beyond information about child feeding during a baseline survey. |
Who may qualify
- Ages
- 4 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- mothers or other primary caretakers aged 18 years or older
- able to read English or Swahili at a level sufficient to understand the SMS messages
- with a child aged 6-18 months at recruitment without signs of severe mental or physical impairments (youngest child if more than one eligible for a given mother)
Key exclusion criteria (3 listed)
- mothers/households without children
- households with children that are outside the age range of 6-18 months at baseline
- mothers who lack basic literacy so as not to understand SMS messages
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 |
|---|---|---|
| Msingi Bora responsive parenting and family wellbeing programMsingi Bora's structured curriculum of 16 biweekly sessions and monthly boosters thereafter are organized around five key messages: love and respect within the family, responsive talk, responsive play, hygiene, and nutrition. | Behavioural | Hybrid mHealth/In-Person Group Delivery, In-Person Group Delivery |
Primary outcome
Child Cognitive Development - Bayley
Time frame: Midline/8-month survey, Endline/24-month survey
The Bayley Scales of Infant Development 3rd edition (Bayley's III) is validated in African settings and provides measures for all dimensions of child development up to 42 months of age. The official age-standardized cognitive scale has a 0-19 range with higher values denoting better scores.
1 secondary outcome
Parenting Behaviors
Time frame: Midline/8-month survey, Endline/24-month survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 39237936Garcia IL, Luoto J, Aboud F, Jervis P, Mwoma T, Alu E, Odhiambo A. In-person versus remote (mHealth) delivery for a responsive parenting intervention in rural Kenya: a cluster randomized controlled trial. BMC Public Health. 2024 Sep 5;24(1):2421. doi: 10.1186/s12889-024-19828-5.
- Derived from this study: PubMed 39184097Garcia IL, Luoto J, Aboud F, Jervis P, Mwoma T, Alu E, Odhiambo A. In-person versus remote (mHealth) delivery for a responsive parenting intervention in rural Kenya: A cluster randomized controlled trial. Res Sq [Preprint]. 2024 Aug 16:rs.3.rs-4733054. doi: 10.21203/rs.3.rs-4733054/v1.
- Individual participant dataSharing planned: Yes. The final dataset will be stripped of identifiers prior to release for sharing. In no way will there be the possibility of deductive disclosure of subjects. We will make the data without identifiers publicly available in accordance with NIH policy by posting it in de-identified form to the Inter-university Consortium for Political and Social Research (ICPSR) data bank. More information on their data confidentiality practices can be found at: https://www.icpsr.umich.edu/web/pages/datamanagement/confidentiality/index.html.
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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.
Italo Lopez Garcia, PhD principal investigator
University of Southern California
Jill E Luoto, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Msingi Bora responsive parenting and family wellbeing program in people with Child Development and Child Behavior, run by University of Southern California 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 3 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Child Cognitive Development - Bayley (time frame: Midline/8-month survey, Endline/24-month survey). 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 NCT06140017, 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 18 Jun 2026.