Evaluating an early childhood care and education program brought to scale in Ghana
| ISRCTN | ISRCTN15360698 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15360698 |
| Secondary identifying numbers | AEARCTR-0008500 |
- Submission date
- 15/12/2021
- Registration date
- 17/12/2021
- Last edited
- 14/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Millions of children in the developing world will not reach their full potential due poor sanitation, nutrition and living in unstimulating environments. Many early childhood care and education programs have been shown to be effective in improving pre-school children’s school readiness and health, but few of those which have been adopted by national governments have either (i) been re-evaluated once they’re delivered at a national level or (ii) been shown to be effective once they have been.
This study team previously evaluated the International NGO Lively Minds ECCE program in a small efficacy trial in northern Ghana, showing it to be effective in boosting cognition and child health. This program has now been adopted by the government of Ghana, and is being rolled out to 61 districts across the north of the country. In partnership with the government and Lively Minds, we have agreed to evaluate the roll of the program using a randomized control trial framework, randomizing the order in which different districts start to receive the program across a 3 year period.
Who can participate?
Study participants are children aged between 3-5 and either enrolled or due to enrol in pre-school in the coming school term.
What does the study involve?
This study involves taking part in two surveys, one immediately prior to the ECCE program being rolled out to participants district and one two to three terms later, where one term is about three months. As the program is now run by the government of Ghana and part of the government policy, researchers have little to no input in its delivery other than randomizing the order in which it gets rolled out to each district.
What are the possible benefits and risks of participating?
Other than gifts given to survey participants as compensation for their time, there are no benefits for taking part in this study. Taking part in the study entails interacting with interviewers, covering topics such as health and maternal empowerment, which some participants may find uncomfortable.
Where is the study run from?
The study is run from the Institute for Fiscal Studies (UK), in partnership with Yale University (USA), the University of Ghana, and International Poverty Action, Ghana.
When is the study starting and how long is it expected to run for?
June 2021 to September 2024
Who is funding the study?
The study is funded by United States Agency for International Development
Who is the main contact?
Dr Sonya Krutikova, sonya_k@ifs.org.uk
Contact information
Scientific
The Institute for Fiscal Studies
7 Ridgmount Street
London
WC1E 7AE
United Kingdom
 ORCID ID |
0000-0003-2488-7489 |
|---|---|
| Phone | 020 7291 4800 |
| sonya_k@ifs.org.uk |
Public
Institute for Fiscal Studies
7 Ridgemont Street
London
WC1E 7AE
United Kingdom
| Phone | 020 7291 4800 |
|---|---|
| sonya_k@ifs.org.uk |
Study information
| Study design | Unblind multi-centre cluster randomized control trial with 1:1 allocation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluation of a pre-school program implemented at scale in Ghana |
| Study objectives | 1. The early child care and education program improves child development when implemented at scale. 2. The early child care and education programme increases child height-for-age Z scores (and reduces rates of stunting) when implemented at scale. |
| Ethics approval(s) | 1. Approved 23/10/2021, UCL Ethics Board (University College London, 2 Taviton Street, London, WC1H 0BT, UK; no telephone number provided; ethics@ucl.ac.uk), ref: 21361/001 2. Approved 22/11/2021, Ghana Health Service Ethics Review Board (Research and Development Division, Ghana Health Service, P.O. box MB 190, Accra, Ghana; no telephone number provided; ethics.research@ghsmail.org), ref: 028/09/21 3. Approval pending, Yale Ethics Review board |
| Health condition(s) or problem(s) studied | Child health and cognitive and socio-emotional development. |
| Intervention | The intervention in this trial is the government implementation of the International NGO's Lively Minds Early Child Care and Education program, with the sequence in which different districts start receiving the program randomly allocated by the research team. The program involves child playgroups for pre-school-aged children, the installation of "Tippy Tap" water sources for hand-washing, pre-school teacher training, and a parenting program, and was previously evaluated by the PI in an earlier study (see https://ifs.org.uk/publications/14922 for details). While the program is scaled to all districts in Northern Ghana, this study focuses on 54 districts (grouped into 9 district groups (DG)) and two cohorts of children, combined into 60 district-cohort pairs. District groups will be enrolled in the study from January 2021 to September 2024 in 5 tranches. In each tranche, one DG is allocated at random into the treatment group and one allocated to the control. District group six is used with different cohorts of children as both a control and treatment district group - control with the first cohort of children, treatment with the second. The control DG in each tranche will begin to receive the program 2 to 3 terms after being enrolled into the study after all data collection has been completed. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured 2 to 3 academic terms (6 - 9 months approximately) after treatment commences: 1. Child cognition as measured using the emergent numeracy, emergent literacy and executive functioning tasks in the IDELA as well as items relating to the same domains from the Harvard Laboratory for Development Studies 2. Child health, as measured using height/weight for age and height for weight Z score 3. Child socio-emotional development, as measured by the externalizing, internalizing and pro-social domains of the Strengths and Difficulty questionnaire and the the socio-emotional items in the IDELA |
| Secondary outcome measures | Measured 2 to 3 academic terms (6 - 9 months approximately) after treatment commences: 1. Maternal mental health (Kessler-10 and WEMWBS) and knowledge of ECCE 2. Teacher knowledge, motivation and teaching quality (measured through classroom observations) 3. Parent-child investment, as measured by quality of the home environment (FCI and HOME) and the parent-child relationship (CPRS) 4. WASH practices in the home 5. Acute Malnutrition measured by MUAC |
| Overall study start date | 01/06/2021 |
| Completion date | 01/09/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 72 clusters with 5 schools per cluster and 9 children per school, providing a sample of 3240 children in total (45 participants per cluster). |
| Key inclusion criteria | 1. Aged between 3 and 5 years 2. Enrolled in the 1st year of preschool or planning to enrol in a sample preschool in the coming term (i.e. they must be in the preschool for the whole duration of the treatment). |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 17/01/2022 |
| Date of final enrolment | 01/02/2023 |
Locations
Countries of recruitment
- Ghana
Study participating centre
Accra
M45
Ghana
Sponsor information
Government
1300 Pennsylvania Avenue
Washington, DC
20523
United States of America
| Phone | +1 202-712-1110 |
|---|---|
| OCRDlist@usaid.gov | |
| Website | https://www.usaid.gov/ |
"ROR" |
https://ror.org/01n6e6j62 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- U.S. Agency for International Development, Agency for International Development, USAID
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the study will be stored in a publicly available repository, either the UK Data Service or the World Bank Microdata archive (conditional on funder requirements). Archived data will be fully anonymous, and consent for the archiving process is sought as part of the participant consent process. The data will be available for research purposes only. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 13/10/2022 | 14/10/2022 | Yes | No |
Editorial Notes
14/10/2022: Publication reference added.
16/12/2021: Trial's existence confirmed by UCL Ethics Board.
