NCT05445947: EASEL

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

Completed NA Last updated 11 December 2023

What this trial tests

NA trial testing The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) Approach in Child Development in 605 participants. Completed in 27 October 2023.

Timeline

6 February 2023

Primary endpoint
27 October 2023

27 October 2023

Quick facts

Lead sponsor	National University of Singapore
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	605
Start date	6 February 2023
Primary completion	27 October 2023
Estimated completion	27 October 2023
Sites	4 locations across Singapore

Drugs / interventions tested

• The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) Approach

Conditions studied

• Child Development — all drugs for Child Development →

Sponsor

National University of Singapore

Who can join

Adults 3 to 75, any sex, with Child Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Assessing the effectiveness and implementation of a universal classroom-based set of educator practices to improve preschool children's social-emotional outcomes: Protocol for a cluster randomized controlled type 2 hybrid trial in Singapore.
   Tan ES, McLeod BD, Mildon RA, Shlonsky A, et al · · 2023 · PMID 37729260 · DOI 10.1371/journal.pone.0291723
2. Assessing the effectiveness and implementation of a universal classroom-based set of educator practices to improve preschool children's outcomes: Protocol for a cluster randomized controlled type 2 hybrid trial in Singapore
   Tan ES, McLeod BD, Mildon RA, Shlonsky A, et al · · 2022 · DOI 10.21203/rs.3.rs-2274099/v1