Early Childhood DevelopmentNCT05129696
Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo"
A study testing Treatment (T) and Treatment + (T+) in people with Early Childhood Development, run by University of California, Berkeley at 1 site in Madagascar.
Trial summary
The overall objective of the study is to examine the effects of integrating early child development group sessions into the existing, at-scale, community health and nutrition programs administered by the government in Madagascar. Read more about this study
- Who is it for?
- Ages 6 months to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Development
- What is being tested?
- Treatment (T) and Treatment + (T+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,150 participants
- Where
- 1 siteMadagascar
- Study dates
- 1 Feb 2021to 31 Mar 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 6 months to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- No other ECD programs present in the community or neighboring communities;
- At least 40 children monitored at the nutrition center in the target age range of 6-30 months (monitored is defined as attending at least one growth monitoring session between July 2019 to August 2020);
- Stable supervisory presence. Local NGOs are contracted to monitor and supervise all community health workers and help to strengthen linkages with local structures such as the community health committees and primary care facilities. Each NGO supervisor is in charge to up to 9 communities, which they visit twice a month. The investigators defined stable presence as not having had NGO turnover within the last year.
- Among the communities included, children 6-30 months were eligible to participate in the intervention. There was no inclusion criteria for community health workers.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial
The overall objective of the study is to examine the effects of integrating early child development group sessions into the existing, at-scale, community health and nutrition programs administered by the government in Madagascar.
Read the detailed description
This research is a cluster-randomized trial that will assess the effects of integrating early child development activities on community health worker time use and caregiver time use and participation in the program. The evaluation will compare the addition of early child development sessions to the status quo health and nutrition program, with an additional intervention arm looking at the addition of toys to the program.
This study has four objectives, which will be measured at the community health worker level, and at the caregiver level for caregiver-child dyads (where children are between 6-30 months old at time of intervention launch):
- Measure how the integration of ECD activities with standard nutrition programming affects the time and task allocation of the community health workers
- Measure the extent, if any, that the addition of ECD activities crowds out community health worker health/nutrition tasks that are part of the standard community program
- Measure how the integration of ECD activities affects rates of caregiver participation in nutrition and health activities over time (e.g., during changes in seasonal activities).
- Measure the impact of enhanced availability and maintenance of age-appropriate play materials/activities on sustained caregiver participation rates in the program.
- Conditions
- Early Childhood Development
- Being tested
- Treatment (T), Treatment + (T+)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment (T)Behavioural
Children area offered to participate in bimonthly group sessions. Each session will have materials and activities appropriate for children spanning a 6-month range (6-12 m, 12-18 m, 12-24 m, 24-30 m) and can accommodate a maximum of 10 children per age group. If more households are interested than can be accommodated by the program, interested families will be randomly selected for participation. A total of 40 children per site will be able to participate in the ECD activities at any one time. With bi-monthly meetings, each child will be exposed to 12 sessions for each age group, and is eligible to transition to the next.
Treatment + (T+)Behavioural
Caregivers/children participating to the group ECD sessions will be invited to play within a play space equipped with books, and homemade/purchased age-appropriate toys. This will be phased in after 6 months of implementation.
| Study group | Role | What they receive |
|---|---|---|
| Control (C): Status quo health and nutrition program | No intervention | Not described |
| Treatment (T): adaption of Reach Up and Learn home visiting program to a group setting | Experimental | Not described Receives: Behavioral: Treatment (T) |
| Treatment + (T+): Enhanced play materials/activities package | Experimental | Not described Receives: Behavioral: Treatment + (T+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community health worker time use
Proportion of working day spent on community health worker activities, measured through recall of hourly time use using monthly phone surveys
Measured: Up to 12 months
Caregiver-child attendance in health and nutrition sessions
Monthly attendance in health and nutrition sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
Measured: Up to 12 months
Caregiver-child attendance in ECD group sessions
Monthly attendance in ECD sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
Measured: Up to 12 months
Secondary outcomes (2)
Community health worker stress
Perceived Stress Scale 4 (PSS-4) administered monthly (Low: 0, High: 16, Higher scores are correlated to more stress)
Measured: Up to 12 months
Community health worker depressive symptoms
Center for Epidemiologic Studies Depression Scale-10 (CESD-10), administered quarterly (Low: 0, High: 30, Higher scores indicate worse symptoms)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Feb 2021
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
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 Early Childhood 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 8,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nevada, Reno, World Bank
- Responsible party
- Sponsor
- Investigators
- Emanuela Galasso, PhD, Principal investigator, World Bank GroupLia Fernald, PhD, Principal investigator, UC Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129696
- Sponsor's protocol ID
- 2019-08-12476
- Status last verified
- Feb 2024
- First submitted
- 28 Oct 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the World Bank's Open Data and Knowledge Initiative, the deidentified data collected in the study will be made publicly available at the data repository at the World Bank, which is expected to be within 24 months of the final data collection date. Metadata and critical documents (i.e. protocols and questionnaires) will conform to the standards of the Data Documentation Initiative and will be made available within one year of the end of data collection.
Publications
Hemlock C, Galasso E, Weber AM, Randriamiarisoa TC, Col M, Dieci M, Ratsifandrihamanana L, Fernald LCH. Integrating early child development into an existing health and nutrition program: evidence from a cluster-randomized controlled trial. BMC Public Health. 2024 Sep 27;24(1):2583. doi: 10.1186/s12889-024-20149-w.
PubMed 39334156Galasso E, Ratsifandrihamanana L, Weber AM, Hemlock C, Col M, Dieci M, Rakotomalala N, Rambeloson V, Fernald LCH. Integrating early stimulation and play at scale: study protocol for "MAHAY Mikolo", a multi-arm cluster-randomized controlled trial. BMC Public Health. 2022 Feb 9;22(1):265. doi: 10.1186/s12889-022-12640-z.
PubMed 35139822
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05129696
- Acronym / sponsor ID
- 2019-08-12476
- Conditions
- Early Childhood Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,150 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of Nevada, Reno, World Bank
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 22 Nov 2021 (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.
The overall objective of the study is to examine the effects of integrating early child development group sessions into the existing, at-scale, community health and nutrition programs administered by the government in Madagascar.
Detailed description
This research is a cluster-randomized trial that will assess the effects of integrating early child development activities on community health worker time use and caregiver time use and participation in the program. The evaluation will compare the addition of early child development sessions to the status quo health and nutrition program, with an additional intervention arm looking at the addition of toys to the program.
This study has four objectives, which will be measured at the community health worker level, and at the caregiver level for caregiver-child dyads (where children are between 6-30 months old at time of intervention launch):
- Measure how the integration of ECD activities with standard nutrition programming affects the time and task allocation of the community health workers
- Measure the extent, if any, that the addition of ECD activities crowds out community health worker health/nutrition tasks that are part of the standard community program
- Measure how the integration of ECD activities affects rates of caregiver participation in nutrition and health activities over time (e.g., during changes in seasonal activities).
- Measure the impact of enhanced availability and maintenance of age-appropriate play materials/activities on sustained caregiver participation rates in the program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (C): Status quo health and nutrition program | No intervention | – |
| Treatment (T): adaption of Reach Up and Learn home visiting program to a group setting | Experimental | Behavioral: Treatment (T) |
| Treatment + (T+): Enhanced play materials/activities package | Experimental | Behavioral: Treatment + (T+) |
Who may qualify
- Ages
- 6 months to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- No other ECD programs present in the community or neighboring communities;
- At least 40 children monitored at the nutrition center in the target age range of 6-30 months (monitored is defined as attending at least one growth monitoring session between July 2019 to August 2020);
- Stable supervisory presence. Local NGOs are contracted to monitor and supervise all community health workers and help to strengthen linkages with local structures such as the community health committees and primary care facilities. Each NGO supervisor is in charge to up to 9 communities, which they visit twice a month. The investigators defined stable presence as not having had NGO turnover within the last year.
- Among the communities included, children 6-30 months were eligible to participate in the intervention. There was no inclusion criteria for community health workers.
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 |
|---|---|---|
| Treatment (T)Children area offered to participate in bimonthly group sessions. Each session will have materials and activities appropriate for children spanning a 6-month range (6-12 m, 12-18 m, 12-24 m, 24-30 m) and can accommodate a maximum of 10 children per age group. If more households are interested than can be accommodated by the program, interested families will be randomly selected for participation. A total of 40 children per site will be able to participate in the ECD activities at any one time. With bi-monthly meetings, each child will be exposed to 12 sessions for each age group, and is eligible to transition to the next. | Behavioural | Treatment (T): adaption of Reach Up and Learn home visiting program to a group setting |
| Treatment + (T+)Caregivers/children participating to the group ECD sessions will be invited to play within a play space equipped with books, and homemade/purchased age-appropriate toys. This will be phased in after 6 months of implementation. | Behavioural | Treatment + (T+): Enhanced play materials/activities package |
Primary outcome
Community health worker time use
Time frame: Up to 12 months
Proportion of working day spent on community health worker activities, measured through recall of hourly time use using monthly phone surveys
Caregiver-child attendance in health and nutrition sessions
Time frame: Up to 12 months
Monthly attendance in health and nutrition sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
Caregiver-child attendance in ECD group sessions
Time frame: Up to 12 months
Monthly attendance in ECD sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
2 secondary outcomes
Community health worker stress
Time frame: Up to 12 months
Community health worker depressive symptoms
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Derived from this study: PubMed 39334156Hemlock C, Galasso E, Weber AM, Randriamiarisoa TC, Col M, Dieci M, Ratsifandrihamanana L, Fernald LCH. Integrating early child development into an existing health and nutrition program: evidence from a cluster-randomized controlled trial. BMC Public Health. 2024 Sep 27;24(1):2583. doi: 10.1186/s12889-024-20149-w.
- Derived from this study: PubMed 35139822Galasso E, Ratsifandrihamanana L, Weber AM, Hemlock C, Col M, Dieci M, Rakotomalala N, Rambeloson V, Fernald LCH. Integrating early stimulation and play at scale: study protocol for "MAHAY Mikolo", a multi-arm cluster-randomized controlled trial. BMC Public Health. 2022 Feb 9;22(1):265. doi: 10.1186/s12889-022-12640-z.
- Individual participant dataSharing planned: Yes. In accordance with the World Bank's Open Data and Knowledge Initiative, the deidentified data collected in the study will be made publicly available at the data repository at the World Bank, which is expected to be within 24 months of the final data collection date. Metadata and critical documents (i.e. protocols and questionnaires) will conform to the standards of the Data Documentation Initiative and will be made available within one year of the end of data collection.
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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.
Emanuela Galasso, PhD principal investigator
World Bank Group
Lia Fernald, PhD principal investigator
UC Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment (T) and Treatment + (T+) in people with Early Childhood Development, run by University of California, Berkeley at 1 site in Madagascar.
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 4 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: finished, as of the sponsor's last update on 27 May 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 Madagascar. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Community health worker time use (time frame: Up to 12 months). The study lists 3 primary outcomes in all. 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 NCT05129696, 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 27 May 2026.