Enhancing And Supporting Early Development to Better Children's Lives (EASEL) Trial (EASEL)

December 4, 2023 updated by: Nikolaos Sevdalis, National University of Singapore
In The Lancet's series on advancing early childhood development, provision of high-quality early childhood care and education was listed as one of the main factors that can maximize children's potential to succeed in later life, particularly children from vulnerable or disadvantaged backgrounds. High-quality early childhood care and education is widely understood to be important for equipping children with essential skills and competencies across academic and non-academic areas, which in turn increases school readiness and has long-reaching impacts on outcomes later in life. Despite the government's efforts to support the early childhood sector, educators in Singapore continue to report difficulties in implementing practices in classrooms that promote children's social, emotional and cognitive development. To enhance educators' skills in these domains, we developed the Enhancing and Supporting Early development to better children's Lives (EASEL) Approach, a set of universal educator-led practices for use with 3-6-year-old children to improve social, emotional, behavioral and executive functioning (SEB+EF) outcomes. This study will evaluate the implementation and effectiveness of the EASEL Approach on improving early childhood educators' teaching practices and in turn, children's SEB+EF outcomes. We will conduct a type 2 hybrid implementation-effectiveness design in a cluster randomized controlled trial in 10-12 childcare centers. We will use the EPIS (Explore, Prepare, Implement, Sustain) Framework to support the implementation of the EASEL Approach. Implementation strategies include training, educator self-assessments, practice-based coaching, and data monitoring. Primary outcomes include educator's teaching practices and their adoption of the EASEL Approach in everyday practice. Secondary outcomes include the acceptability and feasibility of the EASEL Approach and children's SEB+EF outcomes. Quantitative and qualitative data will be collected at baseline, three months and six months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The specific aims of the EASEL trial are two-fold:

  1. The first aim is to test the effectiveness of the EASEL Approach, a universal classroom-based approach (evidence-based classroom practices identified using a common elements approach) on enhancing educators' classroom practices to improve SEB+EF outcomes in preschool children. We hypothesize that the EASEL Approach will improve educators' teaching practices related to promoting preschool children's SEB+EF outcomes. In turn, improvements in children's outcomes in these domains in the longer term (e.g., six months) will also be observed.
  2. The second aim of the trial is to understand how educators implement the EASEL Approach within their classroom and the factors that affect the implementation. We hypothesize that with the use of the implementation strategies proposed for the trial (educator training, educator self-assessment of intention to use and self-efficacy, practice-based coaching, and data monitoring), the EASEL Approach will be well adopted by educators, implemented sustainably and achieve its desired effects.

The EASEL trial is based on three key studies.

  • The Growing Up in Singapore Towards healthy Outcomes (GUSTO) Study: A longitudinal birth cohort study of maternal and child health indicating significant relationships between conditions during pregnancy and early childhood on later outcomes of physical, mental and social well-being.
  • McLeod et al. (2017): This trial builds on the systematic review to identify common elements considered for inclusion as part of the EASEL Approach.
  • Work conducted by Assistant Professor Evelyn Law and colleagues at NUS Yong Loo Lin School of Medicine: The Whole Child Panel (WCP) 2.1 will be used in the EASEL trial as a screening measure of children's executive functioning and the Executive Function Playbook will be included as one of the EASEL practices.

The EASEL trial will employ a Type 2 hybrid implementation-effectiveness design using a cluster randomized controlled trial. A hybrid design approach involves the simultaneous evaluation of both a programme's outcomes as well as the effectiveness of the implementation of the programme. A Type 2 hybrid design also enables the assessment of the feasibility of the programme.

As part of the trial, 12 childcare centres will be randomized to receive training in the EASEL Approach (six sites, referred to as the intervention sites) or continue with business-as-usual (BAU) (six sites). Educators in the BAU group will be provided the option to be trained in the EASEL Approach following completion of the study.

The EASEL trial will be guided by the EPIS (Explore, Prepare, Implement, Sustain) Framework, an evidence-informed framework frequently used in programme implementation and evaluation. The EPIS Framework considers the multilevel nature of service systems (e.g., the early childhood sector in Singapore), the organizations within systems (e.g., individual preschool operators in Singapore), and the 'client' needs (e.g., the needs of children and early childhood educators) when implementing a new programme. It highlights four key phases that guide and describe the implementation process: Exploration, Preparation, Implementation, Sustainment. The Exploration phase involves identifying the problem, developing appropriate and evidence-based solutions, and considering factors that might impact implementation. In this context, the problem is the gap in educators' skills to enhance children's SEB+EF development, and the solution is the EASEL Approach. The Preparation phase consists of a planning process with key stakeholders (e.g., relevant government agencies, preschool operators, individual childcare centers) for the implementation of the new programme. When sufficient preparation has occurred, the Implementation phase commences (implementation of the EASEL Approach by educators in their classrooms). Factors affecting implementation include outer and inner contextual issues (e.g., resource availability, fit with educators' current practices, organizational culture, and attitudes) and consumer concerns (e.g., the applicability of practices for educators' and children's needs). When the new practices have been routinely used, the Sustainment phase can begin. This involves the sustainment of the new programme in the current setting and may also include scaling-up to other settings and systems.

Study Type

Interventional

Enrollment (Actual)

605

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • M.Y. World
      • Singapore, Singapore
        • PAP Community Foundation
      • Singapore, Singapore
        • Presbyterian Preschool Services
      • Singapore, Singapore
        • Skool4Kidz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

For childcare centres:

  • The childcare centre provides full-day programming for children at the Nursery 2 (N2), Kindergarten 1 (K1), and Kindergarten 2 (K2) levels (i.e., children between 3-5 years old at the start of the school year).Childcare centre has one of each class level that can participate in the EASEL trial (e.g., one N2, one K1 and one K2 class in each childcare centre).
  • Childcare centre is not currently implementing other substantial SEB/EF programmes or involved in other trials evaluating SEB/EF programmes

For early childhood educators (adults):

  • Both L1 and L2 educators will be eligible to take part in the trial. Inclusion of educators with a variety of experience will allow the research team to understand the effectiveness of various implementation strategies for each group. L1 educators are certified by the Early Childhood Development Agency (ECDA: government regulatory body for early childhood education) for deployment at nursery, pre-nursery and playgroup (i.e., children aged 18 months-4 years old) and L2 educators are certified by ECDA for deployment at kindergarten, nursery, pre-nursery and playgroup (i.e., children aged 18 months-6 years old).
  • Educators must be ECDA-certified English-language educators.

For children:

  • Children must be enrolled in N2, K1 or K2 classes at the start of the trial.
  • Child is attending the participating childcare centre, in the selected class.
  • Child is enrolled to attend a full-day childcare programme.

For parents/caregivers:

  • Parent/caregiver needs to be the primary caregiver of the target child in the study.
  • Parent/caregiver needs to be able to read/write in English. Where parents/caregivers are not proficient in English, their consent will be sought with the aid of interpreters, but data will only be collected for their child via teacher reports.

Exclusion Criteria:

For childcare centres:

  • Childcare centre does not have at least 1 class at each age level (N2, K1 and K2 level).
  • Childcare centre is currently implementing other substantial SEB/EF programmes or involved in other trials evaluating SEB/EF programmes.
  • Childcare centre is currently involved in other research trials.
  • Childcare centre currently has areas of concerns flagged to ECDA for review.

For early childhood educators (adults):

  • Educator does not have either L1 or L2 certification
  • Educator does not teach primarily in English.

For children:

  • Child attends only a half-day or flexi childcare programme.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Educators working at childcare centers in the intervention group will be trained and provided with ongoing coaching in the EASEL Approach.
Behavioral: The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) Approach

The EASEL Approach consists of a set of educator-led practices that can be incorporated into the daily classroom environment for children three to six years of age. The overall purpose of this approach is to enhance early childhood educators' teaching practices that would promote children's SEB+EF development.

Nine EASEL practices were selected for inclusion in the EASEL Approach. These are a) core fundamental practices that are evidence-based, b) practices that expert stakeholders identified as ones for which local early childhood educators may need additional training, c) practices that are not already covered in pre-service training to avoid replication for educators, d) a combination of practices that educators may already be implementing and can enhance, and new practices, and e) a balance of antecedent and consequential practices (i.e., practices that can be implemented before and after a target behavior).
No Intervention: Control Group
Educators in the control group will continue with business-as-usual. Control group educators will be offered the opportunity to receive training in the EASEL Approach after completion of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in educator's teaching practices and classroom quality
Time Frame: Pre-intervention (i.e., baseline - before training workshop), post-intervention (i.e., 6-month)
The Early Childhood Classroom Observation Measure (ECCOM; Stipek & Byler, 2004) is an observational assessment that involves a 3-hour classroom observation by a trained researcher. Domains on the ECCOM include Management, Climate, and Classroom Instruction. Subdomains under Management include Child Responsibility, Classroom Management, Choices of Activities and Discipline Strategies; subdomains under Climate include Support for Communication Skills, Support for Interpersonal Skills, Student Engagement, Individualization of Learning Activities, and Educator Warmth/Responsiveness; subdomains under Instruction include Learning Standards, Coherence of Instructional Activities, Teaching Concepts, Instructional Conversation and Relevance of Activities to Children's Experience.
Pre-intervention (i.e., baseline - before training workshop), post-intervention (i.e., 6-month)
Change in children's social-emotional development, behaviour and self-regulation skills
Time Frame: Pre-intervention (i.e., baseline), post-intervention (i.e., 6-month)
The Child Self-Regulation and Behavior Questionnaire (CSBQ; Howard & Melhuish, 2017) is a 34-item self-report questionnaire for educators to indicate the option that best fits what each child is like (1 = Not True to 5 = Very True). Items on the CSBQ cover the following domains: Self-regulation (cognitive, emotional, behavioral), Sociability, Prosocial Behavior, Externalizing and Internalizing Behavior, and General Child Development.
Pre-intervention (i.e., baseline), post-intervention (i.e., 6-month)
Change in children's executive functioning
Time Frame: Pre-intervention (i.e., baseline), post-intervention (i.e., 6-month)
The Behavior Rating Inventory of Executive Functioning - Preschool version (BRIEF-P; Gioia et al., 2003) is a 63-item self-report questionnaire for parents to indicate how often a child has had problems with various behaviors in the past six months (0 = Never, 1 = Sometimes, 2 = Often). The BRIEF-P consists of the following indices: Inhibitory Self-Control Index, Flexibility Index, Emergent Metacognition Index, and Global Executive Composite; and the following domains: Inhibit, Shift, Emotional Control, Working Memory, Plan/Organize.
Pre-intervention (i.e., baseline), post-intervention (i.e., 6-month)
Children's executive functioning (screening)
Time Frame: Post-intervention (i.e., 6-month)
The executive functioning tasks from the Singapore Whole Child Panel 2.1 (WCP 2.1) will be administered by the research team with the child to measure executive functioning skills such as working memory and cognitive flexibility. These tasks will take about 10 minutes and will be administered using an electronic device: '8 Boxes' and 'Day and Night'. The WCP 2.1 is a screening measure which will only be administered at the post-intervention timepoint.
Post-intervention (i.e., 6-month)
Change in educator's uptake of EASEL Approach (Intervention Group only)
Time Frame: Pre-intervention (i.e., baseline - after training workshop), mid-intervention (i.e., 3-month), post-intervention (i.e., 6-month)
Educator self-assessments will be used to assess educators' (1) attitudes toward the EASEL practices, (2) perceived norms of the EASEL practices, (3) intentions to use the EASEL practices, and (4) self-efficacy with the EASEL practices.
Pre-intervention (i.e., baseline - after training workshop), mid-intervention (i.e., 3-month), post-intervention (i.e., 6-month)
Frequency and educator's uptake of online EASEL resources (Intervention Group only)
Time Frame: Post-intervention (i.e., 6-month)
Frequency and uptake of online EASEL resources will be assessed through educators' engagement data on Thinkific (e.g., number of times lessons were accessed and completed).
Post-intervention (i.e., 6-month)
Educator's uptake and adoption of EASEL Approach (Intervention Group only)
Time Frame: Post-intervention (i.e., 6-month)
Focus group discussions with groups of key stakeholders (i.e., center leadership and educators in the Intervention Group)
Post-intervention (i.e., 6-month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Singapore

Investigators

  • Principal Investigator: Nikolaos Sevdalis, PhD, NUS Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Actual)

October 27, 2023

Study Completion (Actual)

October 27, 2023

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NUS-IRB-2021-993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are currently in the process of engaging with partners and the decision on whether IPD can be shared will depend on partners' agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child Development

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe