Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000304235p
Ethics application status
Not yet submitted
Date submitted
20/02/2018
Date registered
28/02/2018
Date last updated
28/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcome of Early Start Denver Model “Play Date” for Young Children with Autism and their Peers
Scientific title
Effectiveness of Early Start Denver Model “Play Date” on Engagement, Social Interactions, and Play for Young Children with Autism Spectrum Disorder and their Peers
Secondary ID [1] 294114 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 306706 0
Condition category
Condition code
Mental Health 305806 305806 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. This intervention will involve two 1-hour sessions per week for 12 weeks of ESDM play date intervention delivered to children with ASD and typically developing peers by a therapist who is trained in the ESDM. All sessions will take place in the children with ASD's homes. The materials used during the intervention will be those that are typically available in each family's home, in addition to a range of age appropriate toys (listed in the ESDM manual).
During the initial hour-long ESDM therapy session the therapist will play in a naturalistic way with the child with ASD and a second therapist will note on the ESDM Curriculum Checklist whether or not the child displayed a range of developmental skills. Based on this assessment two to three goals will be selected for each of the nine developmental domains targeted in the ESDM.
During each subsequent play date session the child with ASD's goals will be embedded into the therapist’s play with the children and will be taught by applying the following behaviour analytic teaching principles: (a) the delivery of learning opportunities at least every 30s, (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 children and then allow them 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 therapist will play with the child without an object (e.g. songs, chase, tickles), or using special sensory objects that the child did not operate (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 therapist 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 her face, voice, and actions. When the therapist 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 had done so, he or she will select a new activity.
Furthermore, the therapist will use specific strategies to encourage interaction between the child with ASD and typically developing peer as well as teach the typically developing peer to interact with and teach social communication and play skills to the child with ASD. This will involve setting up play spaces with toys and materials that elicit cooperative play, and providing duplicates of toys and materials to encourage parallel play (e.g. two sets of farm animal toys, or sufficient Duplo blocks for both children to play with). By choosing toys and activities that are interesting to both children, spontaneous motivation and interest in the other play partners will be more likely to develop.
The therapist will also provide active guidance (using appropriate prompting and reinforcement) to the typically developing peers to help them interact with the children with ASD in a way that promotes learning. If the children are engaging at a level where all of the target social behaviours are naturally occurring, the therapist will adopt an ‘invisible helper’ role, where the therapist joins in activities as a play partner and facilitator rather than a director.
Sessions will be terminated after one hour or when the therapist determines from the children’s behaviour that they no longer want to continue.
Fidelity of therapist implementation of the intervention using the ESDM Teaching Fidelity Rating System (Rogers & Dawson, 2010) will be evaluated. The questionnaire has 13 fidelity categories: management of attention, ABC format, instructional techniques, affect and arousal, management of unwanted behaviours, dyadic engagement, motivation, positive affect, sensitivity and responsivity, multiple and varied communication, appropriateness of adult language, joint activity structure and elaboration, and transition between activities. Furthermore, a checklist that corresponds to each phase of the study will also be used to monitor adherence to the intervention. The checklist describes each step of the procedures for each phase of the study. For example, “the session lasted ten minutes from the child taking a toy”, and “researcher responded appropriately to any child attempts to initiate play or interaction”.

Intervention code [1] 300390 0
Behaviour
Intervention code [2] 300391 0
Treatment: Other
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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304868 0
% of intervals containing joint engagement measured by coding 10 min videos of therapist-child interactions for both children with ASD and typically developing peers
Timepoint [1] 304868 0
Measured weekly throughout the study (multiple timepoints of which all are primary timepoints):
1) baseline, weeks 1-3 participant 1 (weeks 1-8 participant 6): measured once a week for a minimum of 3 weeks
2) baseline generalization, weeks 1-3 participant 1 (weeks 1-8 participant 6): measured once a week for up to of 3 weeks during baseline
3) playdate intervention, weeks 4-15 participant 1 (weeks 9-20 participant 6): measured once a week for 12 weeks
4) post-intervention generalization, weeks 16-18 participant 1 (weeks 21-23 participant 6): measured once a week for up to of 3 weeks after intervention
5) follow-up, weeks 23-25 participant 1 (weeks 28-30): measured one month after play date intervention, 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. It is hoped that the first participant will begin baseline on the 02/04/2018, while the final participant will begin baseline on or before the week of 02/09/2019, thus data collection will finish on the 27/03/2020 (30 weeks later).
Primary outcome [2] 304869 0
% of intervals containing joint attention measured by coding 10 min videos of therapist-child interactions for both children with ASD and typically developing peers
Timepoint [2] 304869 0
Measured weekly throughout the study (multiple timepoints of which all are primary timepoints):
1) baseline, weeks 1-3 participant 1 (weeks 1-8 participant 6): measured once a week for a minimum of 3 weeks
2) baseline generalization, weeks 1-3 participant 1 (weeks 1-8 participant 6): measured once a week for up to of 3 weeks during baseline
3) playdate intervention, weeks 4-15 participant 1 (weeks 9-20 participant 6): measured once a week for 12 weeks
4) post-intervention generalization, weeks 16-18 participant 1 (weeks 21-23 participant 6): measured once a week for up to of 3 weeks after intervention
5) follow-up, weeks 23-25 participant 1 (weeks 28-30): measured one month after play date intervention, once a week for 3 weeks
Please note: participants will not all start baseline at the same time.
Primary outcome [3] 304870 0
% of intervals containing play behaviour measured by coding 10 min videos of therapist-child interactions for both children with ASD and typically developing peers
Timepoint [3] 304870 0
Measured weekly throughout the study (multiple timepoints of which all are primary timepoints):
1) baseline, weeks 1-3 participant 1 (weeks 1-8 participant 6): measured once a week for a minimum of 3 weeks
2) baseline generalization, weeks 1-3 participant 1 (weeks 1-8 participant 6): measured once a week for up to of 3 weeks during baseline
3) playdate intervention, weeks 4-15 participant 1 (weeks 9-20 participant 6): measured once a week for 12 weeks
4) post-intervention generalization, weeks 16-18 participant 1 (weeks 21-23 participant 6): measured once a week for up to of 3 weeks after intervention
5) follow-up, weeks 23-25 participant 1 (weeks 28-30): measured one month after play date intervention, once a week for 3 weeks
Please note: participants will not all start baseline at the same time.
Secondary outcome [1] 343428 0
% therapist correct use of ESDM strategies using the ESDM teaching fidelity rating scale
Timepoint [1] 343428 0
Measured weekly throughout the study:
1) playdate intervention: measured once a week for 12 weeks
2) follow-up: measured one month after play date intervention, once a week for 3 weeks
Please note: participants will not all start baseline at the same time.

Eligibility
Key inclusion criteria
Inclusion criteria for participating this study are: (a) the children with ASD meet the diagnostic criteria for ASD diagnosis as determined by administration of the ADOS-2 (Lord et al., 2012) by a trained administrator, and/or a diagnosis from a developmental paediatrician based on the DSM-5 criteria of ASD (American Psychiatric Association, 2013), (b) the children with ASD are attending an early childhood centre, (c) the typically developing peers attend the same early childhood centre as the peer with ASD who he/she will receive play date ESDM intervention with, and (d) consent is obtained to videotape the child with ASD and typically developing peer during play date ESDM intervention sessions.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) the children with ASD do not have another serious or specific medical, genetic, neurological or sensory condition (e.g., Down syndrome, fragile X), (b) the children with ASD are not receiving intensive early intervention of any type at any time during the study, and (c) the typically developing peers do not have a diagnosis of any disability, including any serious or specific medical, genetic, neurological or sensory conditions, based on parent report (e.g. Down syndrome, fragile X),.

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
Single group
Other design features
This study will use a non-concurrent multiple baseline across participants single-case design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study uses single case design methodology so a minimum of three child with ASD-typically developing peer dyads is needed to allow for replication of the effects of the intervention. The effectiveness of the intervention will be determined by calculating the percentage of non-overlapping points between the baseline and intervention phases for the play date ESDM intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2018
Actual
Date of last participant enrolment
Anticipated
2/09/2019
Actual
Date of last data collection
Anticipated
27/03/2020
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 9609 0
New Zealand
State/province [1] 9609 0
Wellington

Funding & Sponsors
Funding source category [1] 298749 0
Charities/Societies/Foundations
Name [1] 298749 0
IHC Foundation New Zealand
Country [1] 298749 0
New Zealand
Funding source category [2] 298750 0
Charities/Societies/Foundations
Name [2] 298750 0
Autism Intervention Trust
Country [2] 298750 0
New Zealand
Funding source category [3] 298751 0
University
Name [3] 298751 0
Victoria University of Wellington
Country [3] 298751 0
New Zealand
Primary sponsor type
Individual
Name
Larah van der Meer
Address
P. O Box 600
Kelburn
Wellington, 6140
Country
New Zealand
Secondary sponsor category [1] 297927 0
None
Name [1] 297927 0
N/A
Address [1] 297927 0
N/A
Country [1] 297927 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299688 0
Health and Disability Ethics Committee
Ethics committee address [1] 299688 0
Ethics committee country [1] 299688 0
New Zealand
Date submitted for ethics approval [1] 299688 0
02/03/2018
Approval date [1] 299688 0
Ethics approval number [1] 299688 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81302 0
Dr Larah van der Meer
Address 81302 0
Victoria University of Wellington
P. O Box 600
Kelburn
Wellington, 6140
Country 81302 0
New Zealand
Phone 81302 0
+64 4 463 9709
Fax 81302 0
Email 81302 0
[email protected]
Contact person for public queries
Name 81303 0
Larah van der Meer
Address 81303 0
Victoria University of Wellington
P. O Box 600
Kelburn
Wellington, 6140
Country 81303 0
New Zealand
Phone 81303 0
+64 4 463 9709
Fax 81303 0
Email 81303 0
[email protected]
Contact person for scientific queries
Name 81304 0
Larah van der Meer
Address 81304 0
Victoria University of Wellington
P. O Box 600
Kelburn
Wellington, 6140
Country 81304 0
New Zealand
Phone 81304 0
+64 4 463 9709
Fax 81304 0
Email 81304 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.