Child DevelopmentEASELNCT05445947
Enhancing And Supporting Early Development to Better Children's Lives (EASEL) Trial
A study testing The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) Approach in people with Child Development, run by National University of Singapore at 4 sites in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 4 sitesSingapore
- Study dates
- 6 Feb 2023to 27 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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):
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Singapore4 sites
M.Y. World
Singapore
PAP Community Foundation
Singapore
Presbyterian Preschool Services
Singapore
Skool4Kidz
Singapore
About this study
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.
Read the detailed description
The specific aims of the EASEL trial are two-fold:
- 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.
- 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
- Child Development
- Being tested
- The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) Approach
- Keywords
- educator, teacher, preschool, child, classroom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) ApproachBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Educators working at childcare centers in the intervention group will be trained and provided with ongoing coaching in the EASEL Approach. Receives: Behavioral: The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) Approach |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in educator's teaching practices and classroom quality
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.
Measured: 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
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.
Measured: Pre-intervention (i.e., baseline), post-intervention (i.e., 6-month)
Change in children's executive functioning
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.
Measured: Pre-intervention (i.e., baseline), post-intervention (i.e., 6-month)
Children's executive functioning (screening)
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.
Measured: Post-intervention (i.e., 6-month)
Change in educator's uptake of EASEL Approach (Intervention Group only)
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.
Measured: 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)
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).
Measured: Post-intervention (i.e., 6-month)
Educator's uptake and adoption of EASEL Approach (Intervention Group only)
Focus group discussions with groups of key stakeholders (i.e., center leadership and educators in the Intervention Group)
Measured: Post-intervention (i.e., 6-month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start6 Feb 2023
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Sevdalis, National University of Singapore
- Investigators
- Nikolaos Sevdalis, PhD, Principal investigator, NUS Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445947
- Sponsor's protocol ID
- NUS-IRB-2021-993
- Acronym
- EASEL
- Status last verified
- Dec 2023
- First submitted
- 24 Jun 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22310560McLeod 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.
PubMed 27562037Aarons 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.
PubMed 21197565Fishman 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.
PubMed 29609213Fishman 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.
PubMed 33005900Maddox 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.
PubMed 31385175Pellecchia 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.
PubMed 27884169Stipek 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.
Vasarri S, Isquith PK. Development of the Behavior Rating Inventory of Executive Function - Preschool Version (Brief-P) in 10 Languages. Value Health. 2014 Nov;17(7):A575. doi: 10.1016/j.jval.2014.08.1933. Epub 2014 Oct 26. No abstract available.
PubMed 27201927Howard 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.
PubMed 28503022Bierman 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
Carter AS, Briggs-Gowan MJ, Davis NO. Assessment of young children's social-emotional development and psychopathology: recent advances and recommendations for practice. J Child Psychol Psychiatry. 2004 Jan;45(1):109-34. doi: 10.1046/j.0021-9630.2003.00316.x.
PubMed 14959805
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing And Supporting Early Development to Better Children's Lives (EASEL) Trial
- ClinicalTrials.gov ID
- NCT05445947
- Acronym / sponsor ID
- EASEL / NUS-IRB-2021-993
- Conditions
- Child Development
- Keywords
- educator, teacher, preschool, child, classroom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The specific aims of the EASEL trial are two-fold:
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) ApproachEducators working at childcare centers in the intervention group will be trained and provided with ongoing coaching in the EASEL Approach. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- 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.
- Children must be enrolled in N2, K1 or K2 classes at the start of the trial.
Key exclusion criteria (10 listed)
- 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.
- Educator does not have either L1 or L2 certification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) ApproachThe 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). | Behavioural | Intervention Group |
Primary outcome
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.
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.
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.
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.
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.
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).
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- BackgroundThe Lancet. Advancing early childhood development: From science to scale: An executive summary for The Lancet's series. Lancet. 2016;389(10064):1-8.
- Background: PubMed 22310560Curran 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.
- Background: PubMed 27562037McLeod 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.
- Background: PubMed 21197565Aarons 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.
- Background: PubMed 29609213Fishman 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.
- Background: PubMed 33005900Fishman 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.
- Background: PubMed 31385175Maddox 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.
- Background: PubMed 27884169Pellecchia 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.
- BackgroundStipek D, Byler P. The early childhood classroom observation measure. Early Child Res Q. 2004;19(3):375-97.
- BackgroundLaw 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.
- Background: PubMed 27201927Vasarri S, Isquith PK. Development of the Behavior Rating Inventory of Executive Function - Preschool Version (Brief-P) in 10 Languages. Value Health. 2014 Nov;17(7):A575. doi: 10.1016/j.jval.2014.08.1933. Epub 2014 Oct 26. No abstract available.
- Background: PubMed 28503022Howard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Sevdalis, PhD principal investigator
NUS Singapore
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The EASEL (Enhancing And Supporting Early Development to Better Children's Lives) Approach in people with Child Development, run by National University of Singapore at 4 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05445947, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.