Condition category
Mental and Behavioural Disorders
Date applied
14/07/2017
Date assigned
11/08/2017
Last edited
04/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Over the past eight years the Royal Government of Bhutan, with the assistance of development partners like Save the Children and UNICEF, has made sustained efforts to promote and institute various kinds of early childhood care and development (ECCD) interventions including school-based programs and parenting education. However, at this time the Ministry of Education only supports school-based ECCD programming in communities that have at least 15 children who are 3-5 years of age. This policy excludes the children and families living in remote parts of the country, who are also those most in need of such services.In response to the need for non-school based ECCD services in rural areas of the country, a home-based solution called the Care for Child Development Program Plus initiative was developed. The program aims to strengthen the existing Care for Child Development Program run by the Ministry of Health by adding 12 sessions about early stimulation and home learning activities, and training village health workers to deliver the program to parents/caregivers of 3-5 year-old children in their communities. The purpose of this pilot program is to both increase access to quality ECCD services and contribute towards improved learning and development outcomes for 3-5 year-old children in rural areas. The results from the intervention will inform design and program implementation for possible scale up in other districts as well as program design for 0-3 year old children in such areas.

Who can participate?

What does the study involve?
Villages in four districts are randomly allocated to one of two groups. Those in the first group are invited to join bi-monthly sessions by health care workers to promote literacy and numeracy at home. They receive 12 parenting sessions twice per month. Those in the second group receive their normal health care. Participating families fill out questionnaire focused on family characteristics and caregiver activities is used to measure impact.

What are the possible benefits and risks of participating?
Participants may benefit from enjoying playing the games in this study. There are minimal risks with participating. Children may feel uncomfortable being interviewed by a stranger but are allowed to decline to participate and stop the assessment even if their parents have given them consent to participate.

Where is the study run from?
This study is being run by Save the Children (Bhutan) and takes place in villages in Bhutan.

When is the study starting and how long is it expected to run for?
December 2016 to December 2017

Who is funding the study?
1. Save the Children (UK)
2. Investigator initiated and funded (UK)

Who is the main contact?
Ms Lauren Pisani

Trial website

Contact information

Type

Public

Primary contact

Mrs Lauren Pisani

ORCID ID

Contact details

University College London (UCL)
Institute of Education
20 Bedford Way
Bloomsbury
London
WC1H 0A
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Determining the effectiveness of an alternative pre-primary education program delivered by community health workers in Bhutan: A cluster-randomized control trial

Acronym

Study hypothesis

1. Does the C4CD Plus program improve learning and development for children aged 3-5?
2. Does the C4CD Plus program improve parenting practices related to early learning?
3. Do all parents and children experience the same benefits (or lack thereof) from the C4CD Plus program?

Ethics approval

UCL Research Ethics Committee, 25/4/2017

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Early childhood learning and development intervention in Bhutan

Intervention

Within the four selected districts, all Gewogs (CHW catchments areas made up of 1-3 villages) are randomly assigned to either the intervention or the control group for program implementation. Then 19 catchment areas are selected for the study (9 intervention, 10 control). Due to the limited population in rural areas of Bhutan, all families with children aged 3-5 within these villages are eligible to participate in the study. A list of eligible villages (no access to center-based early childhood education services and existence of a community health worker) within target districts was compiled by the Ministry of Health and Save the Children, and then a random number generator was used to randomly assign each village into either the treatment or control arm of the study. Thirty-five villages were random selected to be part of the evaluation, and all families with children aged 3-5 were eligible for participation in the study.

Parents in the intervention group are invited to join bi-monthly sessions led by community health workers that focus on how to promote emergent literacy and numeracy at home. Participants receive 12 parenting sessions delivered by twice per month by village health workers. The sessions focus on improving stimulation and home learning practices with children aged 3-5.

Parents in the control group continue to receive route health care but are not offered community parenting sessions. Participants receive no new services and do not have any services withheld.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Children's learning and development as measured by the International Development and Early Learning Assessment (IDELA) are measured at baseline (about one month before intervention begins) and one month after completion.

Secondary outcome measures

Positive parenting-child interactions at home (self-reported) are measured at baseline (about one month before intervention begins) and one month after completion.

Overall trial start date

10/12/2016

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

All parents of children aged 3-5 in selected communities.

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

35 villages with 12 diads (parent and child) per village

Participant exclusion criteria

Parents of children older or younger than 3 - 5 years.

Recruitment start date

01/05/2017

Recruitment end date

31/05/2017

Locations

Countries of recruitment

Bhutan

Trial participating centre

Save the Children
Bhutan Office Chang Geydaphu
Thimphu
N/A
Bhutan

Sponsor information

Organisation

Save the Children Bhutan

Sponsor details

Chang Geydaphu GPO Box 281
Thimphu
N/A
Bhutan

Sponsor type

Other

Website

https://bhutan.savethechildren.net

Funders

Funder type

Not defined

Funder name

Save the Children

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Investigator initated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results of this study will be disseminated as part of my doctoral dissertation defense and then formatted for publication in a high-impact peer reviewed journal. Results will also be disseminated to the Ministries of Education and Health within Bhutan. Preliminary dissemination within Bhutan may occur in 2018; my dissertation defense is tentatively planned for June 2019, and peer reviewed publication would follow.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/08/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes