The role of training and technological innovation in improving early childhood development under home-visiting programmes - a feasibility study

ISRCTN	ISRCTN16602033
DOI	https://doi.org/10.1186/ISRCTN16602033
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Economic and Social Research Council
Funder	Economic and Social Research Council

Submission date: 13/01/2023
Registration date: 14/01/2023
Last edited: 11/08/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The purpose of preschool is to help children grow and develop in different ways, like thinking, moving, and getting along with others. But many young children in poor countries don't have a good place to learn and play. In Ecuador, most children this age don't go to preschool. The government there started a program in 2018 to visit these children at home and help them learn. The program is called SAFPI. Researchers want to study how well the program works and if it can help these children do better. They will use a special study to see if things like teacher training and technology can make a difference in how the children learn and grow.

Who can participate?
The study involves 48 districts in the Sierra regime of Ecuador which have the SAFPI home-visiting programme running for at least one academic year prior to study recruitment. Within these 48 districts, approximately 341 teachers, 1607 children in age group 3-5 years, and their primary caregivers will be surveyed.

What does the study involve?
The study involves training and continuous professional development to SAFPI teachers in the Reggio Emilia Approach. A digital EdTech application will also be developed and provided to the teachers to enable digital submission of home visiting related monitoring forms. This digital submission will be made under a new Monitoring and Information System (MIS) for the Ministry of Education that will produce service delivery metrics from these monitoring forms and provide weekly motivational nudges and reminders to the SAFPI teachers.

What are the possible benefits and risks of participating?
The benefits include better child development outcomes and an improved SAFPI home-visiting programme infrastructure backed by digital innovation. Specific material benefits will accrue to randomly selected half the participating teachers in terms of training. There are no risks from participating in the study.

Where is the study run from?
The study will be run in Ecuador through the National Ministry of Education.

When is the study starting and how long is it expected to run for?
May 2019 to August 2023.
The study will start recruitment in February 2023 in the 48 districts of Sierra academic regime and run for 4 months. The duration includes baseline data collection in February 2023, the feasibility trial period from March to June 2023.

Who is funding the study?
Economic and Social Research Council (ESRC) (UK)

Who is the main contact?
Prof. Gabriella Conti, gabriella.conti@ucl.ac.uk

Contact information

Prof Gabriella Conti
Principal investigator

Department of Economics University College London
Drayton House
30 Gordon Street
London
WC1H 0AN
United Kingdom

Phone	+44 2076794696
Email	gabriella.conti@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Cluster randomized feasibility trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Cluster randomised feasibility study of teacher training and technology-enabled monitoring on childhood development under the SAFPI home visiting programme in Ecuador
Study objectives	Teacher training, technology enabled monitoring and motivational nudges in home-visiting programme (such as the SAFPI in Ecuador) will have positive impacts on early childhood development.
Ethics approval(s)	1. Approved 06/05/2022, UCL IOE Research Ethics Committee (IOE, UCL's Faculty of Education and Society, University College London, 20 Bedford Way, London, WC1H 0AL, UK; +44 (0)20 7679 2000; ioe.researchethics@ucl.ac.uk), ref: UK REC1635 2. Approved 02/09/2022, PUCE Ethics Committee for Research on Human Beings (Dr. Iván Dueñas Espı́n, President, CEISH Av. 12 de octubre 1076 y Roca, Quito, edificio administrativo, piso 3, oficina 327, Ecuador; +593 2991700, ext. 2917; igduenase@puce.edu.ec) ref: PV-21-2022, V2
Health condition(s) or problem(s) studied	Early childhood development
Intervention	Current interventions as of 13/06/2023: The intervention will be randomised at the district level (cluster) in the Sierra academic regime. 48 Districts have been selected using purposive sampling out of the 60 operational SAFPI service districts. The selection of districts was based on the criteria that the district must have had a SAFPI programme running for at least one academic year. The 48 selected districts will then be stratified by their size in terms of number of teachers per district, and on the number of 'new' teachers per district with no previous experience within the SAFPI programme. After stratification, equal number of districts will be assigned to 2 arms. Randomisation will be done on the computer using Stata. There are two study arms: 1. Treatment Arm receiving improved SAFPI programme: The teachers in the treatment arm will receive training in the Reggio Emilia Approach (March 2023 to June 2023). We will also develop a customised EdTech application to enable digital monitoring and tracking of services. 2. Control Arm receiving the standard SAFPI programme: The teachers in the control arm will continue delivering the SAFPI programme without any improvements, that is, no training and no access to digital technology. _____ Previous interventions: The intervention will be randomised at the district level (cluster) in the Sierra academic regime. 48 Districts have been selected using purposive sampling out of the 60 operational SAFPI service districts. The selection of districts was based on the criteria that the district must have had a SAFPI programme running for at least one academic year. The 48 selected districts will then be stratified by their size in terms of number of teachers per district, and on the number of 'new' teachers per district with no previous experience within the SAFPI programme. After stratification, equal number of districts will be assigned to 2 arms. Randomisation will be done on the computer using Stata. There are two study arms: 1. Treatment Arm receiving improved SAFPI programme: The teachers in the treatment arm will receive training in the Reggio Emilia Approach, tablets with internet package and a customised application to enable digital monitoring and tracking of services, and motivational app-based nudges. The treatment will last for 4 months (March 2023 to June 2023). 2. Control Arm receiving the standard SAFPI programme: The teachers in the control arm will continue delivering the SAFPI programme without any improvements, that is, no training, no tablets, no access to digital technology, no motivational nudges.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measure as of 11/08/2023: 1. Pre-literacy and Pre-numeracy using Items 2-8 and Items 15-20 of IDELA at baseline (March 2023) 2. Language development using TVIP at baseline (March 2023) 3. Executive functioning using Delay-Choice Test and Items 13-14 of IDELA at baseline (March 2023) 4. Child Development (caregiver report) using ECDI at baseline (March 2023) _____ Previous primary outcome measure from 13/06/2023 to 11/08/2023: 1. Pre-literacy and Pre-numeracy using Items 2-8 and Items 15-20 of IDELA at baseline 2. Language development using TVIP at baseline 3. Executive functioning using Delay-Choice Test and Items 13-14 of IDELA at baseline 4. Child Development (caregiver report) using ECDI at baseline _____ Previous primary outcome measure: 1. Pre-literacy and Pre-numeracy using Items 2-8 and Items 15-20 of IDELA at baseline and after 4 months 2. Language development using TVIP at baseline and after 4 months 3. Executive functioning using Delay-Choice Test and Items 13-14 of IDELA at baseline and after 4 months (added 30/01/2023) 4. Child Development (caregiver report) using ECDI at baseline and after 4 months
Key secondary outcome measure(s)	Current secondary outcome measures as of 11/08/2023: 1. Motor skills using Items 21-24 of IDELA at baseline (March 2023) 2. Socio-emotional development using Items 1 and Items 9-12 of IDELA, caregiver reported Strength and Difficulties Questionnaire, and scoring of child's self-portrait at baseline (March 2023) 3. Altruism or preference for egalitarianism using adapted Dictator Game at baseline (March 2023) 4. Intervention take-up: teachers' attendance in training sessions 5. Teachers' knowledge of early childhood development measured through a list of true/false statements at baseline (March 2023) 6. Teachers' motivation and job satisfaction measured through a list of likert scale rated statements at baseline (March 2023) 7. Teachers' burnout using Maslach Burnout Inventory for Educators at baseline (March 2023) 8. Biological mothers'/primary caregivers' self-efficacy using likert scale rated list of statements at baseline (March 2023) 9. Home learning environment using shorter adapted versions of FCI and HOME at baseline (March 2023) 10. Biological mother/Primary caregiver - child interactions through coding of 5 minute video of toy-based play at baseline (March 2023) _____ Previous secondary outcome measures from 13/06/2023 to 11/08/2023: 1. Motor skills using Items 21-24 of IDELA at baseline and after 4 months 2. Socio-emotional development using Items 1 and Items 9-12 of IDELA, caregiver reported Strength and Difficulties Questionnaire, and scoring of child's self-portrait at baseline and after 4 months 3. Altruism or preference for egalitarianism using adapted Dictator Game at baseline and after 4 months 4. Intervention take-up: teachers' attendance in training sessions 5. Teachers' knowledge of early childhood development measured through a list of true/false statements at baseline and after 4 months 6. Teachers' motivation and job satisfaction measured through a list of likert scale rated statements at baseline and after 4 months 7. Teachers' burnout using Maslach Burnout Inventory for Educators at baseline and after 4 months 8. Biological mothers'/primary caregivers' self-efficacy using likert scale rated list of statements at baseline and after 4 months 9. Home learning environment using shorter adapted versions of FCI and HOME at baseline and after 4 months 10. Biological mother/Primary caregiver - child interactions through coding of 5 minute video of toy-based play at baseline and after 4 months _____ Previous secondary outcome measures: 1. Motor skills using Items 21-24 of IDELA at baseline and after 4 months 2. Socio-emotional development using Items 1 and Items 9-12 of IDELA, caregiver reported Strength and Difficulties Questionnaire, and scoring of child's self-portrait at baseline and after 4 months 3. Altruism or preference for egalitarianism using adapted Dictator Game at baseline and after 4 months 4. Intervention take-up: teachers' attendance in training sessions and teachers' usage of the tablet based cutomised application. Both will be measured in real time throughout the intervention period. 5. Teachers' knowledge of early childhood development measured through a list of true/false statements at baseline and after 4 months 6. Teachers' motivation and job satisfaction measured through a list of likert scale rated statements at baseline and after 4 months 7. Teachers' burnout using Maslach Burnout Inventory for Educators at baseline and after 4 months 8. Biological mothers'/primary caregivers' self-efficacy using likert scale rated list of statements at baseline and after 4 months 9. Home learning environment using shorter adapted versions of FCI and HOME at baseline and after 4 months 10. Biological mother/Primary caregiver - child interactions through coding of 5 minute video of toy-based play at baseline and after 4 months
Completion date	31/08/2023

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	3 Years
Upper age limit	5 Years
Sex	All
Target sample size at registration	3214
Key inclusion criteria	1. All SAFPI teachers in study districts. Study districts are included if they have had an operating SAFPI programme for at least one academic year prior to study recruitment 2. Children aged 3 - 5 years enrolled in the SAFPI programme 3. Biological mother or primary caregiver of the child
Key exclusion criteria	No exclusion criteria except that teachers and biological mothers/primary caregivers are able to provide informed consent. That biological mothers/primary caregivers can provide informed consent on behalf of their child.
Date of first enrolment	07/02/2023
Date of final enrolment	28/02/2023

Locations

Countries of recruitment

Ecuador

Study participating centre

Ministry of Education

Av. Amazonas N34-451 y Av. Atahualpa
Quito
170507
Ecuador

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	The datasets generated will be published as a supplement to the results publication. In this case, the data will be anonymised. The participants will be made aware of this in the information leaflet and the informed consent. The participants will also be informed of their right to withdraw and/or ask for deletion of their data. In the case of withdrawal and/or deletion of data, participants will also be made aware that any data that has already been analysed and process for publication, cannot be excluded.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/08/2023: The following changes were made to the trial record:
1. The public title was changed to add "a feasibility study".
2. The primary and secondary outcome measures were updated.
13/06/2023: The following changes were made to the trial record:
1. The scientific title was changed from "Cluster randomised evaluation of teacher training and technology-enabled monitoring on childhood development under the SAFPI home visiting programme in Ecuador" to "Cluster randomised feasibility study of teacher training and technology-enabled monitoring on childhood development under the SAFPI home visiting programme in Ecuador".
2. The study design was changed from "Cluster randomized control trial" to "Cluster randomized feasibility trial".
3. The interventions were changed.
3. The primary outcome measure was changed.
4. The secondary outcome measures were changed.
5. The plain English summary was updated to reflect these changes.
01/02/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 23/01/2023 to 07/02/2023.
2. The recruitment end date was changed from 15/02/2023 to 28/02/2023.
3. The plain English summary was updated to reflect these changes.
30/01/2023: The primary outcome measure was updated
13/01/2023: Trial's existence confirmed by PUCE Ethics Committee for Research on Human Beings.