Effectiveness of Educational Module of Autism Spectrum Disorder (EMASD) in Identifying Children with ASD among preschool teachers

Last registered on September 04, 2022

Pre-Trial

Trial Information

General Information

Title
Effectiveness of Educational Module of Autism Spectrum Disorder (EMASD) in Identifying Children with ASD among preschool teachers
RCT ID
AEARCTR-0009925
Initial registration date
August 13, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
August 18, 2022, 2:46 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
September 04, 2022, 3:28 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
Taiz university, Yemen

Other Primary Investigator(s)

Additional Trial Information

Status
Withdrawn
Start date
2019-07-01
End date
2019-09-28
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Introduction: There is consensus that the main system for ASD identification relies on the preschool teacher. they have the chance to referrals of suspicious children with ASD to specialists. However, there is little literature is available on preschool teachers' ability or perception for this role. The main objective of this study is to evaluate the feasibility and acceptability of an educational module to identify children with ASD (EMASD). Also, to assess the effectivness of the EMASD on improving preschool teacher’s ability to identify children with ASD in a normal school.
Method and Analysis: This pilot study will examine the feasibility of the randomised controlled trial (RCT) using EMASD as an intervention. The intervention will be ten weekly group-based sessions designed to improve the knowledge, belief, identification skills, and self-efficacy to identify children with ASD among Yemeni preschool teachers. The feasibility will be determined based on the effectiveness as measured by questionnaires and open-ended questions. General linear measurement (GLM) will be used to compare between the two groups and within the group whereas thematic analysis will be used for qualitative data.
Ethics and Dissemination: This study conforms to the principles of the Declaration and Research Ethics Committee at University Putra Malaysia (UPM), with a reference number of UPM\TNCPI\RMC\JKEUPM\1.4.18.2 (JKEUPM). (STUDY PROTOCOL PROOFS 2).
External Link(s)

Registration Citation

Citation
taresh, sahar. 2022. "Effectiveness of Educational Module of Autism Spectrum Disorder (EMASD) in Identifying Children with ASD among preschool teachers." AEA RCT Registry. September 04. https://doi.org/10.1257/rct.9925-1.1
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Experimental Details

Interventions

Intervention(s)
EMASD can be used to help preschool teachers identifying children suspected with ASD in normal schools. Therefore, the educational sessions in EMASD are designed based on the ADDIE model and two main theories, namely the Social Cognitive Theory (SCT) in triadic reciprocal determination (behavioural, personal, and environmental factors) and the Health Belief Module (HBM) to change the preschool teachers’ belief towards ASD. Both theories are used to indicates the methods to dispel misbeliefs surrounding ASD. Furthermore, EMASD is also developed based on the ADDIE (Analysis-Design-Development-Implement-Evaluation) model (Supplementary file 2). Walter Dick (48) emphasised that any instructional design requires the use of a system to analyse the problems and identify learning objectives before a strategic plan can be established to solve teaching problems, test solutions, evaluate the results and revise the programme. Among the many systematic instructional design models available in the literature, the ADDIE model is the commonly used model. For more details of the theoretical framework development, please see 10.3390/brainsci10030165.
The EMASD consists of 10 sessions that cover different aspects including i. Cognitive (Knowledge: Definition based on DSM5, symptoms, types, causes, prevalence, and the difference between ASD symptoms and other disorders); ii. Beliefs (Emotional: Social misbelief, religious belief, and the correction of the belief about ASD); iii. Identification skills (Motor-behaviour: report writing, observation, and recording skills; iv. Self-efficacy (Emotional: Preschool teachers’ responsibility in the identification of ASD and discussion with parents regarding the referral decision). Table 1 outlines the components in EMASD.
The EG will consist of four groups with approximately 10 to 20 teachers respectively. The intervention module will be organised based on the agreement and consensus of the participants. The session will be arranged flexibly based on the schedules of the participants. In addition, a two-hour booster session will be provided to reinforce the intervention and for the participants to discuss further issues related to ASD that will promote further referral services.
Furthermore, the intervention will include activities such as group discussions, brainstorming, short video viewing, exercises, and sharing of teachers' and parents' experiences to enhance early detection and referral. Besides, the intervention will also be outlined in two booklets for trainers and teachers. The intervention will be performed by the first author with the support of the school counsellor. During the intervention period, a WhatsApp group that contains only the EG participants will be created to support the intervention and to boost retention rates. The group will be moderated by the lead facilitator. To further enhance the retention rates, weekly reminders will be sent via private messaging to the EG participants.
Intervention Start Date
2019-08-03
Intervention End Date
2019-08-25

Primary Outcomes

Primary Outcomes (end points)
increase Preschool Teachers’ Knowledge of ASD
change Preschool Teachers’ belief of ASD
enhance preschool teachers self efficacy to identify children with ASD
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
enhance preschool teacher ability to identify children with ASD
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The current study is a convergent parallel mixed study to evaluate the influence of the EMASD by applying both qualitative and quantitative methods to enrich the study findings. The parallel randomised controlled trial (P-RCT) compared changes in outcomes of interest among preschool teachers allocated to the EMASD experimental group against preschool teachers allocated to a control group (no intervention). The data collection involved obtaining quantitative data via questionnaire and qualitative data via open-ended questions. The quantitative and qualitative data findings was examined separately before contributing to the final interpretation.
The current study was based in the province of Taiz, Yemen. There were 125 government schools and 230 private schools in the province. Preschool teachers from these schools is recruited. The study was promoted on the Teachers' Qualification Training Course website of the Ministry of Education. The principals of all the schools was also be contacted formally via emails to obtain their approvals. Before the pre-test assessment, all the participants must provide informed consent digitally.
2.2.1. Selection Criteria
The sampling unit of this study is a teacher randomly selected from the schools in Taiz based on the following inclusion and exclusion criteria:
Inclusion Criteria
The inclusion criteria for schools and teachers were:
i. School should be kindergarten, preschool, or primary schools.
ii. Schools located in Taiz.
iii. Schools that agree to participate in the study.
iv. Teachers who are teaching at the kindergarten, preschool, or primary stage.
vi. Teachers aged 20-40 years old.
vii. Teachers who sign a consent form to participate in the study.
viii. Teachers with at least a high school level of education.
Exclusion Criteria
The exclusion criteria are:
i. School location is not in Taiz.
ii. Elementary and high schools.
iii. Teachers who will retire during the study period.
iv. Teachers who teach in elementary and high schools.
v. Teachers with lower than high school education levels.
After completing the pre-test assessment, all participants who are qualified to participate were stratified depending on their position and score to ensure a balance between the EG and CG. An impartial researcher is randomly assign participants to either EG or CG using computer-generated allocation, i.e. JavaScript's Math Random Number Generator (hedges.name) (47). As the EMASD intervention will be provided by the researchers, double-blinding of group allocation is not possible. Figure 2 depicts the recruitment procedure. To ensure allocation concealment, each cluster was receive a randomly generated treatment allocation unique code within a serially numbered sealed opaque envelope. The research assistant distributes the sealed opaque envelopes to all the participating schools. Later, the participants was open the envelopes and be assigned to EG or CG according to their unique codes. The software was also categorise EG and CG based on the list of codes. Finally, an equal number of participants was assigned to the EG and CG. Participants in the CG was continue with the standard teaching qualification course at the Ministry of Education. To assess potential preliminary differences between the two groups, measurements will be performed at Week 10 after the intervention period and again, four weeks after the post-test. Following the study completion, the participants in the CG was also receive an information pack on the relevant information and activities related to EMASD.
Experimental Design Details
Randomization Method
Randomization control trial
Randomization Unit
preschool teachers
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
12 schools
120 participants
60 for experimental group
Sample size: planned number of observations
not more than 15 teachers in one group
Sample size (or number of clusters) by treatment arms
20 preschool teacher
12 schools
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The sample was used as a part of the research community, while some procedures were applied to calculate the sample size. In this case, Lemeshow equation was employed to detect the sample size between the experimental and control groups. Notably, this equation is the most widely used approach to compare two groups of equal size and identify the intervention effect on the outcome in pre-post studies (Ary et al., 2018). Furthermore, the Lemeshow test assesses the significance of the difference between two population means, which may be found in the case when the two means are based on the same sample of subjects or matched-pair samples. In this study, this equation was used to assess the two correlated means of EG and CG. As indicated by (Lwanga et al., 1991) the sufficient sample measure for randomised controlled trial was based on α (error sort I, α = 0.05), β (error sort II, β = 0.20), p (level of knowledge in ASD among pre-school teachers) (Lwanga et al., 1991), and d2 (contrast to be recognized amongst experimental and control collection) (Perels et al., 2009).See Table 3.4 n=〖〖2σ^2 (Z〗_(1-α)+Z_(1-β))〗^2/〖(M_1-M_2)〗^2 To determine a suitable sample size adjustment for clustering, standard sample size estimates for individually randomised designs were calculated first and inflated by the design effect (Campbell & Stanley, 2015; Lwanga et al., 1991). n=(2x0.053 〖〖(5.38)〗^2+ (2.65)〗^2)/(21.57-18.93)=20.23 As mentioned above, the calculated sample size n = 100 would be considered the sample size in this study. To calculate adequate sample size adjusting for clustering, the standard sample size was inflated by the effect size, as shown below: Effect size = 1 + (M - 1) x ICC = 1 + (16 – 1) x 0.05 = 1.75 20.23 x 1.75 (effect size of cluster random sampling) = 35.40 Where; ICC = 0.05 (Intra-cluster correlation) (Ary et al., 2018). M = 16 (Average Cluster Size; the average number of pre-school teacher for each cluster) Assuming the drop from 10 % = 17 + 35.40 = 52.40, eight participants were added into the final sample size, n = 120. They were equally distributed between the experimental (60) and control (60) groups, as it was previously determined according to the equation of the sample size.
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
the Declaration and Research Ethics Committee at University Putra Malaysia (UPM), with a reference number of
IRB Approval Date
2019-01-29
IRB Approval Number
UPM\TNCPI\RMC\JKEUPM\1.4.18.2 (JKEUPM).
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
August 25, 2019, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
August 25, 2019, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
15 schools
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
60 preschool teachers
Final Sample Size (or Number of Clusters) by Treatment Arms
12 schools , 60 preschool teachers
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Abstract
Background: Increasing efforts have been focused on providing a quality education for children with Autism Spectrum Disorder (ASD) after identifying them at an early stage. Preschool teachers play a major role in the main ASD identification system as they represent the gatekeepers to identify and refer any children suspected of ASD to specialists. However, there is little literature available on the ability of preschool teachers of their perception regarding this role. Aim: The main objective of this study is to evaluate the feasibility and acceptability of an educational module to identify children with ASD (EMASD). The second objective is to assess the initial impact of the EMASD on improving preschool teacher’s ability to identify children with ASD in a normal school. Method: This pilot study will examine the feasibility of the randomised controlled trial (RCT) using EMASD as an intervention. The intervention will be ten weekly group-based sessions designed to improve the knowledge, belief, identification skills, and self-efficacy to identify children with ASD among Yemeni preschool teachers. The teachers will be randomly assigned to the intervention group that will receive the EMASD and the control group without any intervention. The feasibility will be determined based on the effectiveness as measured by questionnaires and open-ended questions. General linear measurement (GLM) will be used to compare the outcome scores in the questionnaire between the two groups and within the group whereas thematic analysis will be used to analyse the open-ended questions. Expected outcomes: The findings from this study will give critical empirical data about the feasibility of EMASD. Discussion: EMASD has the potential to increase the ability of preschool teachers to detect children with ASD. The findings from the feasibility study will be utilised to improve the research protocol of the randomised controlled trial and to ensure a better design of an intervention for a larger powered trial in the future.
Citation
Sahar Mohammed Taresh, Nor Aniza Ahmad, Samsilah Roslan et al. Effectiveness of Educational Module of Autism Spectrum Disorder (EMASD) in Identifying Children with ASD among preschool teachers: A Study Protocol for Parallel Cluster-Randomized Controlled Trial feasibility study, 29 September 2021, PREPRINT (Version 1) available at Research Square [https://doi.org/10.21203/rs.3.rs-923156/v1]

Reports & Other Materials