Condition category
Mental and Behavioural Disorders
Date applied
23/03/2018
Date assigned
16/05/2018
Last edited
16/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Early childhood care and education (ECCE) is critical to a child's development and their success in adult life. Children who receive quality ECCE are proven to be healthier, do better and stay longer in school, and have better economic trajectories in adult life. In impoverished rural northern Ghana, children do not receive these vital opportunities. Despite recent advances in Ghana’s Education System (GES), two barriers to ECCE persist: (i) Low quality Kinder Garten (KG), marred by a lack of trained teachers, large class sizes, lack of play-based resources, teacher absenteeism and rote-based teaching; and (ii) low level of maternal education, information and aspiration in deprived rural communities. Lively Minds' innovation overcomes both of these challenges by training and empowering official KG teachers and mothers in highly deprived communities to set up and run educational play schemes (covering hygiene and stimulation) using local materials. To achieve sustainability, scalability and cost-effectiveness, play schemes are mainstreamed into and are designed to strengthen the Government KG system and are based on a training of trainers approach. The Institute for Fiscal Studies (IFS), in partnership with Innovation for Poverty Action (Ghana) will design and implement a randomised controlled trial in 80 rural communities in Northern and Upper East regions of Ghana, to evaluate impacts of the Lively Minds programme on the targeted children, their siblings and caregivers, volunteer mothers who run the play-schemes and teachers who train the volunteer mothers. The study will evaluate impacts on target child’s physical, cognitive and socio-emotional development, as well as the home environment and primary caregiver’s knowledge, perceptions and well-being. The evidence provided by this evaluation will be crucial for determining whether there is value in mainstreaming the programme across Ghana and replicating it in other countries.

Who can participate?
There are three kinds of participants in this study. The primary participants in this study are children between 3 and 5 year old, and either currently attending or intending to attend one of the 80 study schools. Participants can be either male or female and are not required to have any specific condition or health status. The intervention also recruits volunteers to run the play scheme. Volunteers can be of any age, but must be female. This is because a core component of the program is female empowerment. Finally teachers are also trained as part of the intervention. To participate they must be existing kindergarten teachers at one of the treatment schools.

What does the study involve?
The intervention focuses on unlocking the potential of caregivers, both mothers and teachers, training and empowering them with the knowledge, skills and confidence to run educational Play Schemes in kindergarten classes and provide better care and stimulation at home, using local materials. This intervention involves three main steps; (i) Kindergarten teachers are trained at centralised workshops, this includes the importance of education and play and how to train mothers. (ii) Teachers then train roughly 30 women from the community; this includes how to play games, child-friendly teaching and health practices. (iii) Play schemes run – a group of trained mothers come into kindergarten each day of the week for one hour. In the session 6 mothers teach 30 kindergarten children indoors, whilst the remaining children play outside. Children learn by playing a variety of games that strengthen six key skills – numeracy, sorting, creativity, reading, sensory awareness and physical education. Health and hygiene is also incorporated with children having to handwash with soap before starting the session. Throughout the year mothers and teachers are continually supported through regular additional trainings. The intervention lasts a total of 10 months.
40 of the study schools will be randomly assigned to receive the intervention, and 40 schools randomly assigned to be part of the control group; who will receive the intervention one year later. Surveys will be administered to the participants, their primary caregiver, household head, and siblings, as well as to kindergarten teachers and community elders. These surveys will take place at baseline (before the start of the intervention) and endline (soon after the end of the intervention). A shorter survey will also be administered to children halfway through the intervention.

What are the possible benefits and risks of participating?
We expect that children will directly benefit from increased cognitive and socio-emotional developmental outcomes as a result of the intervention, as well as improved hygiene practices. Volunteer mothers should benefit from an increased knowledge of childhood learning and health and hygiene practices, and potentially improved self-esteem and well being from feeling valued as members of the scheme. Teachers should benefit from increased knowledge of teaching practices which will aid them in their work.
There are known no risks to participation in the intervention, and all participation is completely voluntary.

Where is the study run from?
The study is run from a total of 80 government schools across two districts in rural Northern Ghana; Bongo district (Upper East region) and Tolon district (Nothern region)

When is study starting and how long is it expected to run for?
The study is starting in July 2017 and will run for just over a year, finishing in September 2018.

How long will the trial be recruiting participants for?
The trial will be recruiting participants for the total duration of the study of 15 months. The study is kindly funded by two partners; the Jacobs foundation and the Global Innovation Fund.

The main contacts are:
1. Prof. Orazio Attanasio
o.attanasio@ucl.ac.uk
2. Dr. Sonya Krutikova
sonya_k@ifs.org.uk








Trial website

Contact information

Type

Public

Primary contact

Dr Sonya Krutikova

ORCID ID

Contact details

Institute for Fiscal Studies
7 Ridgmount St
Fitzrovia
London
WC1E 7AE
United Kingdom
+44 (0)207 291 4800
sonya_k@ifs.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AEARCTR-0002777

Study information

Scientific title

Improving early childhood development in rural Ghana through scalable low-cost community run play schemes : a cluster randomised controlled trial

Acronym

Study hypothesis

The main hypothesis is that the intervention will lead to positive impacts on child physical, cognitive and socio-emotional development as well as hygiene practices. It is hypothesised that this impact will occur through a combination of the following intermediate outcomes:
1. Direct impact from child’s participation in the Play Schemes
2. Indirect impact through improvements in Mothers’ stimulation and care practices (through acquiring knowledge in the training sessions and interaction with Volunteer Mothers)
3. Indirect impact through improvements in Mothers’ psychological wellbeing
4. Indirect impact through a change in resource allocation (time and material) within the households by primary caregivers having more say
5. Indirect impact through increased knowledge and awareness among Kindergarten Teachers on good stimulation and hygiene practices (through training) and reduced Teacher absenteeism (through higher motivation and improved accountability as a result of mothers’ enhanced pre-school engagement)
6. Indirect impact on children who have not participated in the Play Scheme through interaction with siblings who have

Ethics approval

1. University College London (UCL), UCL Ethics Committee, 11/07/2017, 10167/001
2. Innovations for Poverty Action (IPA) - USA, Ethics Review, 21/06/2017, #14340
3. Ghana Health Services Ethics Review Committee (GHSER), 03/09/2017, GHSERC012/07/17

Study design

Evaluator-blinded randomised controlled cluster study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Condition

Childhood cognitive, socio-emotional, and motor development and hygiene practices.

Intervention

The intervention focuses on unlocking the potential of caregivers, both mothers and teachers, training and empowering them with the knowledge, skills and confidence to run educational Play Schemes in kindergarten classes and provide better care and stimulation at home, using local materials. The intervention will be carried out by Lively Minds, an award-winning organisation that has been running the programme in rural Ghana (as well as Uganda) for 8 years. The structure of the program is as follows:
1. Kindergarten teachers trained at centralised workshops. There are ten practical and participatory sessions, which cover the importance of education and play, classroom management, how to use and make games, and how to train Mothers.
2. Teachers train 30 Mothers in their community. Training includes two community meetings and nine participatory workshops. It is designed for women who are illiterate and have never been to school. Content includes how to make and play games, child-friendly teaching, and health practices. The syllabus uses behaviour-change and play-based approaches to transform mindsets, gain buy-in and volunteerism. Teachers are supervised and supported by high performing Kindergarten Teachers from schools with existing Schemes.
3. Play Schemes run. A different group of 7 Mothers come into kindergarten each day of the week for an hour. 6 Mothers teach 30 kindergarten children indoors (1:5 parent child ratio). The remaining children and Mothers participate in outdoor play. The teachers supervise. Children learn by playing with a variety of games that strengthen six different skillsets (counting/numeracy; matching/sorting; imagination and creativity; reading/books; sensory awareness; and physical education). These crosscutting skills develop executive functions, providing the foundation for learning. Teaching uses discovery and play-based methods, rather than rote method which is the norm in school.
4. Health and hygiene activities are incorporated.Children have to handwash with soap before using the Scheme, sensitising them to this vital practice. Mothers are also taught how to erect simple handwashing devices (tippy-taps) at home. Once the Schemes are running, Mothers and teachers are given regular training on health and parenting topics to improve their childcare.
5. Teachers and Schemes are supported. Play Schemes are given regular supervisory visits by Lively Minds staff and GES officials to quality control. Regular "top-up'' training sessions are held for teachers where they discuss problems, share successes and also are trained to provide the Mothers with monthly skills workshops.
6. Mothers are supported. Mothers are given monthly workshops on parenting and health topics and life skills by Teachers (topics include nutrition, hygiene, child rights, play, communication, malaria prevention, financial awareness, self-esteem, inclusive education). This increases awareness on a variety of childcare and public health issues, reinforces new behaviours, and is a powerful incentive to keep the Mothers committed to volunteering.
7. Sustainability and scalability. District Education officials are involved in the mobilisation and training of schools. They monitor the Schemes and supervise the teachers and schools as part of their normal supervisory duties. High performing teachers and officials are trained to participate in the training and support of new cadres of teachers. Play Scheme Committees are established in each community.

The study is a cluster-randomised controlled trial, with the school as the unit of randomization. The trial take will take place across two districts in rural Northern Ghana; Bongo district, Upper East region and Tolon district, Northern region. Across these two regions, 80 schools will be selected to be part of the study. Within these schools, 40 will be randomly allocated to receive the intervention, and 40 allocated to the control group, who will receive the intervention at the end of the study. Randomisation will stratify using circuit (a geographical cluster of on average 6 schools falling under one supervisor from the Ghana Education Service), and school size (defined as high or low, based on whether the school has above or below the median number of total Kindergarten children). Randomisation will be conducted using Stata 14. The participants are unblinded to their treatment status, however the data collectors and enumerators are blinded.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The primary outcome is children’s cognitive and socio-emotional developmental outcomes. We will measure developmental outcomes of the child, through the use of the International Development and Early Learning Assessment (IDELA) tool, developed by Save the Children. This provides measures of development along 5 core domains; emergent numeracy, emergent literacy, socio-emotional skills, motor skills, and executive function. The full set of primary outcomes will be measured at two timepoints; baseline - before the start of the intervention (September 2017), and endline - soon after the end of the intervention 10 months later (August 2018). In addition a reduced form of the IDELA will be delivered at midline - the midway point of the intervention (March 2018).

Secondary outcome measures

All of the following will be measured at baseline and midline:
1. Target children’s health outcomes - we will collect data on the incidence of diarrhoea, fever and respiratory infections using the definitions of the WHO as measures of morbidity. We will also measure arm circumference.
2. Developmental outcomes of siblings - we will measure the development of younger siblings through the Caregiver-Reported Early Development Index (CREDI) short form, and of older siblings through Ravens progressive matrices and tests of basic literacy and numeracy. Child pre-school attendance and participation in the Play Schemes - the household survey will collect details on target child’s pre-school attendance.
3. Maternal knowledge of child stimulation and care practices - we will collect information on the mother’s knowledge of stimulation and care practice, and her beliefs regarding the importance of these for children’s development. To test knowledge, we will rely on a selection of items from the Knowledge of Infant Development (KIDI).
4. Psychological well-being of primary caregivers - We will measure psychological wellbeing outcomes of primary caregivers through the use of two scales: the SRQ-20 measure of depression and the Rosenberg measure of Self-esteem.
5. Enhanced quantity of resources allocated to child within the households - the presence of toys and learning materials in the house will be assessed together with parental involvement with the child, the child’s routines and organisation of the child’s time inside and outside the family house. This will be assessed using the Family Care Indicators, developed by UNICEF.
6. Target children’s hygiene knowledge - we will construct a hygiene knowledge score based on child’s responses to questions such as what are good times to wash your hands, what material is needed to wash hands and what are reasons for why washing hands is important.
7. Pre-school engagement of primary caregivers - we collect data on the frequency of primary caregivers’ school visits and the extent to which they know the teacher’s name
8. Teacher wellbeing, teaching practices and knowledge - we will measure outcomes of teachers using an instrument developed in a previous study in Ghana. This includes a variety of measures including teacher presence, practices, burnout and job satisfaction. The SRQ-20 will also be administered to teachers to assess their mental wellbeing. Given the small sample size of teachers in our study, however, we may not have sufficient power to detect significant impacts on this outcome.

Overall trial start date

01/01/2017

Overall trial end date

14/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

There are three kinds of participants in the study; target children, volunteer mothers, and kindergarten teachers. The inclusion criteria are as follows:
1. Children
To be part of the intervention, children have to be attending the kindergarten of one of the 40 treatment schools. They can be either male or female. Officially only those aged 4 and 5 are supposed to be attending kindergarten, however in reality there are many children who attend that are not in this age range. Of these total participants, a subset will be chosen to be part of our sample and therefore surveyed. These children are chosen as a random sample of all children meeting the following inclusion criteria:
1.1. Aged 3-5 years as of the start of the school term 11th September 2017
1.2. Reported in July 2017 that they are either currently attending one of the 80 study schools or intend to do so come the start of school term in September 2017
2. Mothers
Volunteers in the place scheme can be anyone willing to take part as long as they are female – this is because a major focus of the program is on female empowerment. Our sample of volunteer mothers to be surveyed will be made up from the sample of primary caregivers. Hence to be eligible to be surveyed, individuals must be the primary caregiver of one of the sampled target children.
3. Teachers
The only requirement of kindergarten teachers is that they are a teacher in one of the study schools as of the start of the intervention in October 2017. All kindergarten teachers in the study schools will be surveyed.

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

2400 participants in 80 schools

Participant exclusion criteria

Inclusion criteria not met.

Recruitment start date

11/07/2017

Recruitment end date

18/09/2018

Locations

Countries of recruitment

Ghana

Trial participating centre

KPANIYILI AME
N/A

Trial participating centre

FEO-AWIISI D/A PRIMARY/KG
N/A
Ghana

Trial participating centre

GOWRIE-TINGRE KG
N/A
Ghana

Trial participating centre

DUA D/A PRIMARY/KG
N/A
Ghana

Trial participating centre

KASULIYILI RC
N/A
Ghana

Trial participating centre

NAYORIGO D/A KG
N/A
Ghana

Trial participating centre

APUWONGO PRIMARY/KG
N/A
Ghana

Trial participating centre

ST. AUGUSTINE R/C KG/PRIMARY
N/A
Ghana

Trial participating centre

VEA D/A KG
N/A
Ghana

Trial participating centre

GOWRIE KG
N/A
Ghana

Trial participating centre

GOO-ATANDAA KG
N/A
Ghana

Trial participating centre

KANSOE D/A KG/PRIMARY
N/A
Ghana

Trial participating centre

TINDANG HANATIYA
N/A
Ghana

Trial participating centre

TIBOGUNAYILI AHMADIYA
N/A
Ghana

Trial participating centre

KPENDUA AHMADIYA
N/A
Ghana

Trial participating centre

JAGRIGUYILI AME ZION
N/A
Ghana

Trial participating centre

TALI RC
N/A
Ghana

Trial participating centre

CHIRIFOYILI RC
N/A
Ghana

Trial participating centre

GBRUMANI-TIBOGU DA
N/A
Ghana

Trial participating centre

WANTUGU EA
N/A
Ghana

Trial participating centre

WALA DA
N/A
Ghana

Trial participating centre

TAMALGU ANGLICAN
N/A
Ghana

Trial participating centre

KUGLOGU EA
N/A
Ghana

Trial participating centre

GBULAHGU AME ZION
N/A
Ghana

Trial participating centre

WANTUGU RC
N/A
Ghana

Trial participating centre

ZALI EA
N/A
Ghana

Trial participating centre

KOBILMAHIGU DA
N/A
Ghana

Trial participating centre

DIMABI DA
N/A
Ghana

Trial participating centre

GOLINGA PRESBY
N/A
Ghana

Trial participating centre

NAMOO-DOONE KG/PRIMARY
N/A
Ghana

Trial participating centre

AMANGA D/A KG
N/A
Ghana

Trial participating centre

BUNGU D/A KG/PRIMARY
N/A
Ghana

Trial participating centre

SIKABIISI D/A KG/PRIMARY
N/A
Ghana

Trial participating centre

AMOYAAMA KG
N/A
Ghana

Trial participating centre

AZAMBUO D/A KG/PRIMARY
N/A
Ghana

Trial participating centre

ST. JOHN BOSCO R/C PRIMARY/KG
N/A
Ghana

Trial participating centre

KUNGURU DA
N/A
Ghana

Trial participating centre

KANGBAGU SDA
N/A
Ghana

Trial participating centre

KPAACHIYILI DA
N/A
Ghana

Trial participating centre

AGOMO D/A KG
N/A
Ghana

Trial participating centre

ASAKULSI D/A PRIMARY/KG
N/A
Ghana

Trial participating centre

LEEMBIISI-MOSHIDABOORO
N/A
Ghana

Trial participating centre

DUA-KANTIA D/A KG/PRIMARY
N/A
Ghana

Trial participating centre

GHANA DAA R/C PRIMARY
N/A
Ghana

Trial participating centre

BEO-NAYIKURA D/A KG/PRIMARY
N/A
Ghana

Trial participating centre

KADARE D/A PRIMARY/KG
N/A
Ghana

Trial participating centre

AYONE D/A KG
N/A
Ghana

Trial participating centre

NYARIGA D/A KG/PRIMARY
N/A
Ghana

Trial participating centre

VEA-KULPEELGA KG
N/A
Ghana

Trial participating centre

TARONGO D/A PRIMARY/KG
N/A
Ghana

Trial participating centre

KANKO-OM D/A PRIMARY
N/A
Ghana

Trial participating centre

KODOROGO D/A PRIMARY
N/A
Ghana

Trial participating centre

BALUNGU D/A KG/PRIMARY
N/A
Ghana

Trial participating centre

BALUNGU-GANLAGRUM D/A PRIMARY/KG
N/A
Ghana

Trial participating centre

FATHER LEBEL MEMORIAL RC
N/A
Ghana

Trial participating centre

ATANSEKA KG
N/A
Ghana

Trial participating centre

AWAA D/A KG
N/A
Ghana

Trial participating centre

GAMBRONGO D/A PRIMARY/KG
N/A
Ghana

Trial participating centre

ABELINZANGA D/A KG/PRIMARY
N/A
Ghana

Trial participating centre

KANFEHIYILI EA
N/A
Ghana

Trial participating centre

TINGOLI RC
N/A
Ghana

Trial participating centre

NGABA ZION
N/A
Ghana

Trial participating centre

BUYILI DA
N/A
Ghana

Trial participating centre

WANTUGU TUNTEEYA
N/A
Ghana

Trial participating centre

YOGGU DA
N/A
Ghana

Trial participating centre

KPALIGUN ZION
N/A
Ghana

Trial participating centre

ASSEIYILI AME ZION
N/A
Ghana

Trial participating centre

ZOOLANYILI EA
N/A
Ghana

Trial participating centre

GBRUMANI AHMADIYA
N/A
Ghana

Trial participating centre

YOBZERI DA
N/A
Ghana

Trial participating centre

TALI EA
N/A
Ghana

Trial participating centre

GBANJONG AME ZION
N/A
Ghana

Trial participating centre

YIPELUGU AME ZION
N/A
Ghana

Trial participating centre

KPALSOGU AME ZION
N/A
Ghana

Trial participating centre

FIHINI ZION
N/A
Ghana

Trial participating centre

KURIGUVUHIYAYILI EA
N/A
Ghana

Trial participating centre

NYUJAGYILI EA
N/A
Ghana

Trial participating centre

GURUMANCHAGYILI EA
N/A
Ghana

Sponsor information

Organisation

Institute for Fiscal Studies

Sponsor details

7 Ridgmount St
Fitzrovia
London
WC1E 7AE
United Kingdom
020 7291 4800
mailbox@ifs.org.uk

Sponsor type

Research organisation

Website

Funders

Funder type

Not defined

Funder name

Jacobs Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Global Innovation Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The full anonymised data set will be made publicly available on the IFS website 2 years after the trial end date. This will be publicly accessible for anyone, given a short registration form where they will provide contact details. This will be available for any type of analyses that the user wishes to conduct. Full consent was gained from all participants, and all data made available will be fully anonymised with no names, or other personal identifiers.

Intention to publish date

14/06/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes