The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000324213
Ethics application status
Approved
Date submitted
21/02/2018
Date registered
5/03/2018
Date last updated
3/03/2020
Date data sharing statement initially provided
27/03/2019
Date results information initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Early Start Denver Model (ESDM) in an Inclusive Preschool Setting.
Scientific title
Evaluation of the Effectiveness of an Inclusive Preschool-Based Approach to Early Intervention for Young Children with Autism Based on the Early Start Denver Model.
Secondary ID [1] 293910 0
None
Universal Trial Number (UTN)
U1111-1208-6978
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 306389 0
Condition category
Condition code
Mental Health 305475 305475 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Early Start Denver Model (ESDM) is a routines-based naturalistic developmental behavioural intervention for children with, or at risk for ASD under the age of 5. See Rogers and Dawson's (2010) manual: Early Start Denver Model for Young Children with Autism for more information. The intervention for this research is a simplified version of the ESDM, where ESDM techniques will be implemented during a selected period of the day to target specific behaviours, rather than embedded into all routines and interactions to target many behaviours, as with traditional ESDM. The intervention will consist of 3 x 60 minute sessions per week (totaling 180 minutes per week) of ESDM teaching delivered to young children with ASD by a therapist who is trained in the ESDM (Arm 1) or their regular preschool teacher (Arm 2), who will receive a brief ESDM training package before delivering the intervention. This training package will be specifically designed for this study. All sessions will take place at the child’s regular preschool and the intervention will be embedded in regular preschool activities and routines so may consist of one-on-one, small group and/or whole class teaching, depending on the child's specific target behaviour(s) and the period of the day when the intervention is implemented. The materials used during the intervention will be those that are typically available in each preschool. Prior to the introduction of the intervention, the researcher will work with each participant’s teachers and parents to define specific communication and social behaviours to target during the intervention. During each 60-minute ESDM therapy session, the child's individually defined goals will be embedded into the interventionist’s play with the child and will taught by applying the following behaviour analytic teaching principles: (a) the delivery of frequent learning opportunities, (b) delivery of clear antecedents, (c) the use of reinforcement, and (d) the use of instructional strategies such as prompting, shaping, chaining, and fading. At the beginning of each session, the therapist will greet the child and then allow him or her to verbally or non-verbally (e.g. leading the adult to the activity or object, pointing) choose the first activity, either by presenting a limited choice of two options or allowing the child to choose any toy or activity. Teaching will occur through the use of two types of routines: sensory social routines, in which the interventionist will play with the child without an object (e.g. songs, chase, tickles), or using special sensory objects operated by the interventionist alone (e.g. balloons, bubbles, shaving foam); and joint activity routines, in which the therapist and the child will play together with an object (e.g. blocks, books, balls). Throughout these routines, the interventionist will maintain a positive affect, employ strategies to maximise the child’s motivation (e.g., offering choices, following the child’s lead, and being sensitive and responsive to all attempts at communication), and make conscious attempts to attract and maintain the child’s attention to his/her face, voice, and actions. When the interventionist determines that there are no more learning opportunities during the chosen activity, the child seems bored, or the child initiates finishing an activity, the therapist will instruct the child to tidy up and, once the child has done so, he or she will select a new activity. Sessions will be terminated after one hour or when the interventionist determines from the child’s behaviour that he or she no longer wants to continue. Adherence to intervention will be monitored through recording of participants' session attendance and interventionist's fidelity of implementation.
Intervention code [1] 300178 0
Behaviour
Comparator / control treatment
This study will use a single case design so will not involve a control group. Each child's baseline will serve as their own control. The study involves two separate arms with two separate groups of participants however the two groups will not be compared.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304887 0
% of intervals containing individually defined child behaviour(s) measured by coding 10 min videos of interventionist-child interactions
Timepoint [1] 304887 0
Measured periodically throughout the study: 1) baseline: measured 5 – 10 times over a 3-week period, 2) intervention: measured once a week for 10 weeks, 3) follow-up: measured one month after intervention ends, once a week for 3 weeks Please note: participants will not all start baseline at the same time, and the point at which they begin baseline depends on when they are able to be recruited. Also, the intervention is being delivered in a preschool setting, where the entire preschool closes for holidays four times per year for 2 – 5 weeks. This may impact upon the length of time that participants spend in the study because the delivery of the intervention and data collection will have to fit around these holidays. It is hoped that the first participant will begin baseline on the 05/03/2018, while the final participant will begin baseline on or before the week of 10/09/2018, thus data collection will finish on the 22/02/2019 (24 weeks later).
Secondary outcome [1] 343487 0
(Arm 2 only) % teacher correct use of ESDM strategies using the ESDM teaching fidelity rating scale
Timepoint [1] 343487 0
Measured periodically throughout the study: 1) baseline: measured 5 – 10 times over a 3-week period, 2) intervention: measured once a week for 10 weeks, 3) follow-up: measured one month after intervention ends, once a week for 3 weeks. Please note: not all participants will start baseline at the same time.

Eligibility
Key inclusion criteria
Inclusion criteria for participating in this study are: (a) the child is under the age of 5 years (60 months) at the start of the study; (b) the child has a clinical diagnosis of ASD or meets criteria for an ASD diagnosis based on an assessment using the autism diagnostic observation schedule (Lord et al., 2012); and (c) the participating parent/caregiver provides consent for their child to be videotaped during intervention sessions.
Minimum age
1 Years
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for this study are: (a) the child does not have another serious or specific medical, genetic, neurological or sensory condition (e.g., Down syndrome, fragile X), and (b) the child is not receiving intensive early intervention of any type at any time during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study uses single-case design methodology so a minimum of three participants is needed to allow for replication of the effects of the intervention. The study involves two separate arms, participants from both arms will receive the same intervention (simplified ESDM) however, for Arm 1 the intervention will be delivered by a certified therapist and for Arm 2 the intervention will be delivered by participant's regular preschool teachers. Participants will not receive the interventions during the same time span of the study as Arm 2 will begin after the final participant from Arm 1 has begun receiving the intervention.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The effectiveness of the intervention will be determined by calculating the percentage of non-overlapping points between the baseline and intervention phases.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9613 0
New Zealand
State/province [1] 9613 0
Wellington

Funding & Sponsors
Funding source category [1] 298534 0
University
Name [1] 298534 0
Victoria University of Wellington
Address [1] 298534 0
Victoria University of Wellington
PO Box 600
Wellington 6140
NEW ZEALAND
Country [1] 298534 0
New Zealand
Primary sponsor type
Individual
Name
Jessica Tupou
Address
Victoria University of Wellington
PO Box 600
Wellington 6140
NEW ZEALAND
Country
New Zealand
Secondary sponsor category [1] 297973 0
None
Name [1] 297973 0
Address [1] 297973 0
Country [1] 297973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299509 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 299509 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 299509 0
New Zealand
Date submitted for ethics approval [1] 299509 0
15/02/2018
Approval date [1] 299509 0
09/03/2018
Ethics approval number [1] 299509 0
18/CEN/29

Summary
Brief summary
The Early Start Denver Model (ESDM) is a comprehensive naturalistic developmental behavioural intervention for young children with ASD. There is emerging evidence to suggest that ESDM therapy delivered by trained professionals in autism-specific group settings, with a child-teacher ratio of 1:3 or 1:4, may improve outcomes for young children with ASD. There does not appear to be any research investigating the effects of ESDM when implemented in an inclusive preschool environment, with higher child-teacher ratios.
This study consists of two related arms, both will use the same intervention (a simplified version of ESDM), however for Arm 1, the interventionist will be a certified ESDM therapist and for Arm 2 the interventionist will be the participating child’s regular preschool teacher. The main aim of this research is to examine whether a simplified version of the ESDM can lead to improved outcomes for young children with ASD when delivered in an inclusive preschool setting by a certified ESDM therapist (Arm 1) or the child's regular preschool teacher (Arm 2). Effectiveness will be measured via changes in individually defined child social-communicative behaviours/skills. In addition, Arm 2 will investigate the feasibility of using a brief training program to teach regular preschool teachers to use ESDM strategies in an inclusive preschool setting. Feasibility will be measured via teacher fidelity of implementation and teachers' perceptions of the training program and ESDM intervention which will be measured via a questionnaire and in-depth interviews.
The research aims to answer the following five research questions: 1. For three preschool-aged children with autism spectrum disorder who are attending an inclusive preschool setting, will implementation of a simplified version of the ESDM for 3 hours per week for 10 weeks lead to improvements in the children’s individually defined communication and social behaviours? 2. Will participation in a brief training process, involving online modules, and in vivo practice, enable regular preschool teachers to implement a simplified version of the ESDM with 80% or better procedural integrity in an inclusive preschool setting? 3. After completing the training process and implementing a simplified version of the ESDM, will regular preschool teachers rate the training process and intervention as acceptable and effective? It is hypothesised that children’s individually defined communication and social behaviours will improve during the intervention and that, for Arm 2, teachers' implementation of the ESDM techniques will improve following the training programme. It is also hypothesised that teachers will rate both the training programme and the intervention to be acceptable and effective.
Trial website
Trial related presentations / publications
Public notes
Received verbal approval at ethics committee meeting on 27/02/2018 and written confirmation on 09/03/2018
Attachments [1] 2547 2547 0 0

Contacts
Principal investigator
Name 80658 0
Mrs Jessica Tupou
Address 80658 0
Victoria University of Wellington
PO Box 600
Wellington 6140
NEW ZEALAND
Country 80658 0
New Zealand
Phone 80658 0
+6440221271558
Fax 80658 0
Email 80658 0
Jessica.Tupou@vuw.ac.nz
Contact person for public queries
Name 80659 0
Mrs Jessica Tupou
Address 80659 0
Victoria University of Wellington
PO Box 600
Wellington 6140
NEW ZEALAND
Country 80659 0
New Zealand
Phone 80659 0
+6440221271558
Fax 80659 0
Email 80659 0
Jessica.Tupou@vuw.ac.nz
Contact person for scientific queries
Name 80660 0
Mrs Jessica Tupou
Address 80660 0
Victoria University of Wellington
PO Box 600
Wellington 6140
NEW ZEALAND
Country 80660 0
New Zealand
Phone 80660 0
+6440221271558
Fax 80660 0
Email 80660 0
Jessica.Tupou@vuw.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For ethical reasons, individual participants' data will be kept confidential to the research team.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7212 0
Ethical approval
Citation [1] 7212 0
Link [1] 7212 0
Email [1] 7212 0
Other [1] 7212 0
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 7211 0
Tupou, J., Waddington, H., van der Meer, L., & Sigafoos, J. (2020). Effects of a low-
intensity early start Denver model-based intervention delivered in an inclusive
preschool setting. International Journal of Developmental Disabilities.
doi:10.1080/20473869.2019.1707434.
Attachments [1] 7211 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary