Enhancing And Supporting Early Development to Better Children's Lives (EASEL) Trial
NCT ID: NCT05445947
Last Updated: 2023-12-11
Study Results
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Basic Information
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COMPLETED
NA
605 participants
INTERVENTIONAL
2023-02-06
2023-10-27
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention Group
Educators working at childcare centers in the intervention group will be trained and provided with ongoing coaching in the EASEL Approach.
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).
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.
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
75 Years
ALL
Yes
Sponsors
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National University of Singapore
OTHER
Responsible Party
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Nikolaos Sevdalis
Academic Director
Principal Investigators
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Nikolaos Sevdalis, PhD
Role: PRINCIPAL_INVESTIGATOR
NUS Singapore
Locations
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M.Y. World
Singapore, , Singapore
PAP Community Foundation
Singapore, , Singapore
Presbyterian Preschool Services
Singapore, , Singapore
Skool4Kidz
Singapore, , Singapore
Countries
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References
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The Lancet. Advancing early childhood development: From science to scale: An executive summary for The Lancet's series. Lancet. 2016;389(10064):1-8.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
McLeod BD, Sutherland KS, Martinez RG, Conroy MA, Snyder PA, Southam-Gerow MA. Identifying Common Practice Elements to Improve Social, Emotional, and Behavioral Outcomes of Young Children in Early Childhood Classrooms. Prev Sci. 2017 Feb;18(2):204-213. doi: 10.1007/s11121-016-0703-y.
Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health. 2011 Jan;38(1):4-23. doi: 10.1007/s10488-010-0327-7.
Fishman J, Beidas R, Reisinger E, Mandell DS. The Utility of Measuring Intentions to Use Best Practices: A Longitudinal Study Among Teachers Supporting Students With Autism. J Sch Health. 2018 May;88(5):388-395. doi: 10.1111/josh.12618.
Fishman J, Lushin V, Mandell DS. Predicting implementation: comparing validated measures of intention and assessing the role of motivation when designing behavioral interventions. Implement Sci Commun. 2020 Sep 28;1:81. doi: 10.1186/s43058-020-00050-4. eCollection 2020.
Maddox BB, Crabbe SR, Fishman JM, Beidas RS, Brookman-Frazee L, Miller JS, Nicolaidis C, Mandell DS. Factors Influencing the Use of Cognitive-Behavioral Therapy with Autistic Adults: A Survey of Community Mental Health Clinicians. J Autism Dev Disord. 2019 Nov;49(11):4421-4428. doi: 10.1007/s10803-019-04156-0.
Pellecchia M, Beidas RS, Marcus SC, Fishman J, Kimberly JR, Cannuscio CC, Reisinger EM, Rump K, Mandell DS. Study protocol: implementation of a computer-assisted intervention for autism in schools: a hybrid type II cluster randomized effectiveness-implementation trial. Implement Sci. 2016 Nov 25;11(1):154. doi: 10.1186/s13012-016-0513-4.
Stipek D, Byler P. The early childhood classroom observation measure. Early Child Res Q. 2004;19(3):375-97.
Law EC, Chong SC, Nadarajan R, Broekman BFP, Rifkin-Graboi A, Shorey S, et al. Pediatrics and the multidimensional nature of school readiness: A population-based study.
Gioia GA, Espy KA, Isquith PK. The Behaviour Rating Inventory of Executive Function - Preschool version (BRIEF-P). Odessa, FL; 2003.
Howard SJ, Melhuish E. An Early Years Toolbox for Assessing Early Executive Function, Language, Self-Regulation, and Social Development: Validity, Reliability, and Preliminary Norms. J Psychoeduc Assess. 2017 Jun;35(3):255-275. doi: 10.1177/0734282916633009. Epub 2016 Feb 28.
Bierman KL, Torres M. Promoting the development of executive functions through early education and prevention programs. In: Executive function in preschool-age children: Integrating measurement, neurodevelopment, and translational research. 2015. p. 299-326.
O'Connor EE, Dearing E, Collins BA. Teacher-child relationship and behavior problem trajectories in elementary school. Am Educ Res J [Internet]. 2011 Feb 1 [cited 2021 Feb 10];48(1):120-62. Available from: http://journals.sagepub.com/doi/10.3102/0002831210365008
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Ang L, Lipponen L, May Yin SL. Critical reflections of early childhood care and education in Singapore to build an inclusive society. Policy Futur Educ [Internet]. 2020 Nov 23 [cited 2020 Dec 7];147821032097110. Available from: http://journals.sagepub.com/doi/10.1177/1478210320971103
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Bautista A, Ng SC, Múñez D, Bull R. Learning areas for holistic education: kindergarten teachers' curriculum priorities, professional development needs, and beliefs. Int J Child Care Educ Policy [Internet]. 2016 Dec 1 [cited 2021 Jan 5];10(1):8. Available from: https://ijccep.springeropen.com/articles/10.1186/s40723-016-0024-4
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Tan ES, McLeod BD, Mildon RA, Shlonsky A, Seah CKF, McCrickerd K, Goh E, Kembhavi G. 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. PLoS One. 2023 Sep 20;18(9):e0291723. doi: 10.1371/journal.pone.0291723. eCollection 2023.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NUS-IRB-2021-993
Identifier Type: -
Identifier Source: org_study_id