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
ACTRN12618000254291
Ethics application status
Approved
Date submitted
2/02/2018
Date registered
16/02/2018
Date last updated
1/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcome of Early Start Denver Model Direct Therapy in addition to Parent Training for Young Children with Autism
Scientific title
Effectiveness of Early Start Denver Model Direct Therapy in addition to parent training for improving parent use of ESDM techniques and imitation, expressive language, and engagement in their young children with autism spectrum disorder..
Secondary ID [1] 293948 0
Nil known
Universal Trial Number (UTN)
U1111-1208-8318
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autism spectrum disorder 306446 0
Condition category
Condition code
Mental Health 305533 305533 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 90 minutes per week of ESDM parent coaching delivered to parents of children with ASD by a therapist who is trained in the ESDM parent coaching for 12 weeks. This will be followed by two 1-hour weekly sessions of ESDM direct therapy delivered by trained therapists for 12 weeks. All sessions will take place in parents' 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).
ESDM parent coaching sessions will have the following format: 1) Greeting- the therapist will greet the parent and gather any data that the parent may have collected; 2) Progress report- the parent and therapist will discuss the focus for the previous week, how well this approach worked for the child, and the main focus for the current week (will not occur in week 2); 3) Warm up activity- the parent will interact with the child using the previous week’s techniques (data collected in this phase, will not occur in week 2), 4) Reflection on warm up- the therapist and the parent will jointly reflect on the warm-up activity; 5) Topic discussion- the parent will decide whether the therapist will cover a new topic or further discuss the previous week’s topic, 6) Activity 2- the parent will practice the techniques from the topic discussion; 7) Reflection on Activity 2; 8) Activity 3- the parent will practice the techniques from the topic discussion in a different activity; 9) Reflection on Activity 3; 10) Planning for following week (will not occur in Week 12).
During each hour long ESDM therapy session the child's goals will be embedded into the therapist’s play with the child and will 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 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 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. Sessions will be terminated after one hour or when the therapist determines from the child’s behaviour that he or she no longer wants to continue.
Intervention code [1] 300213 0
Behaviour
Intervention code [2] 300251 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] 304660 0
% parent correct use of ESDM strategies using the ESDM teaching fidelity rating scale
Timepoint [1] 304660 0
Measured weekly or fornightly throughout the study:
1) baseline: measured once a week for a minimum of 3 weeks
2) parent coaching: measured once a week 12 weeks
3) post parent coaching: measured once a week for 5 weeks
4) direct therapy: measured fortnightly for for 12 weeks
5) follow-up: measured one month after direct therapy, 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 23/04/2018, while the final participant will begin baseline on or before the week of 3/09/2018, thus data collection will finish on the 27/5/2019 (37 weeks later).
Primary outcome [2] 304661 0
% of intervals containing imitation measured by coding 10 min videos of parent-child or parent-therapist interactions
Timepoint [2] 304661 0
Measured weekly throughout the study:
1) baseline: measured once a week for a minimum of 3 weeks
2) parent coaching: measured once a week 12 weeks
3) post parent coaching: measured once a week for 5 weeks
4) direct therapy: measured once a week for for 12 weeks
5) follow-up: measured one month after direct therapy, once a week for 3 weeks
Please note: participants will not all start baseline at the same time.
Primary outcome [3] 304662 0
% of intervals containing expressive language (i.e. functional utterances) measured by coding 10 min videos of parent-child or parent-therapist interactions
Timepoint [3] 304662 0
Measured weekly throughout the study:
1) baseline: measured once a week for a minimum of 3 weeks
2) parent coaching: measured once a week 12 weeks
3) post parent coaching: measured once a week for 5 weeks
4) direct therapy: measured once a week for for 12 weeks
5) follow-up: measured one month after direct therapy, once a week for 3 weeks
Please note: participants will not all start baseline at the same time.
Secondary outcome [1] 342716 0
% of intervals containing joint engagement measured by coding 10 min videos of parent-child or parent-therapist interactions
Timepoint [1] 342716 0
Measured weekly throughout the study:
1) baseline: measured once a week for a minimum of 3 weeks
2) parent coaching: measured once a week 12 weeks
3) post parent coaching: measured once a week for 5 weeks
4) direct therapy: measured once a week for for 12 weeks
5) follow-up: measured one month after direct therapy, 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 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); (c) the participating parent/caregiver provides consent to allow videotaping of their interactions with the child,
Minimum age
1 Years
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) the child does not have another serious or specific medical, genetic, neurological or sensory condition (e.g., Down syndrome, fragile X), (b) the child is not receiving intensive early intervention of any type at any time during the study, and (c) the participating parent/caregiver has been involved in no more than one other autism specific parent training/support programme and is not currently involved in any other parent training programmes during the present 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
Who is / are masked / blinded?



Intervention assignment
Other design features
This study will use a multiple baseline across participants design
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This study uses single case design methodology so a minimum of three parent-child 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 both the parent coaching and direct ESDM therapy interventions.

Recruitment
Recruitment status
Active, not recruiting
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] 9552 0
New Zealand
State/province [1] 9552 0
Wellington

Funding & Sponsors
Funding source category [1] 298576 0
Charities/Societies/Foundations
Name [1] 298576 0
IHC New Zealand
Address [1] 298576 0
57 Willis St, Wellington, 6011
Country [1] 298576 0
New Zealand
Funding source category [2] 298577 0
University
Name [2] 298577 0
Victoria University of Wellington
Address [2] 298577 0
P. O Box 600
Kelburn
Wellington, 6140
Country [2] 298577 0
New Zealand
Primary sponsor type
Individual
Name
Hannah Waddington
Address
Victoria University of Wellington
P. O Box 600
Kelburn
Wellington
6140
Country
New Zealand
Secondary sponsor category [1] 297731 0
None
Name [1] 297731 0
Address [1] 297731 0
Country [1] 297731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299543 0
Health and Disability Ethics Committee
Ethics committee address [1] 299543 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 299543 0
New Zealand
Date submitted for ethics approval [1] 299543 0
16/02/2018
Approval date [1] 299543 0
Ethics approval number [1] 299543 0
Ethics committee name [2] 300270 0
Health and Disability Ethics Committee
Ethics committee address [2] 300270 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [2] 300270 0
New Zealand
Date submitted for ethics approval [2] 300270 0
28/02/2018
Approval date [2] 300270 0
23/03/2018
Ethics approval number [2] 300270 0
HDEC 18STH 59

Summary
Brief summary
The early start Denver model (ESDM) is a routines-based naturalistic developmental behavioural intervention for young children with or at risk for autism spectrum disorder. There is emerging evidence to suggest that less than ten hours per week of ESDM therapy delivered by trained professionals may improve outcomes for young children with ASD. There is also evidence to suggest that, while ESDM parent coaching is generally successful in teaching most parents to implement the ESDM techniques with a high level of fidelity, increased parent use of these techniques does not always lead to increases in all outcomes for their children with ASD.. There does not appear to be any research investigating whether the addition of a few hours a week of ESDM delivered by trained professionals leads to an improvement in child outcomes above and beyond the child improvements at the end of ESDM parent coaching.
The main aim of this study is to evaluate the effectiveness of ESDM parent coaching followed by low-intensity direct ESDM therapy for improving imitation, expressive language, and joint engagement for young children with, or at risk for, ASD. Specifically, the study aims to answer the following four research questions
1. Is 90 min a week of ESDM parent coaching over 12 weeks effective in enabling parents to implement ESDM intervention procedures with fidelity?
2. Does 90 min a week of ESDM parent coaching over 12 weeks produce an increase in imitation, expressive language, and joint engagement for young children with ASD?
3. Does 2 hours a week of therapist implemented ESDM intervention (direct ESDM therapy) for 12 weeks produce an increase in imitation, expressive language, and joint engagement for young children with ASD, whose parents have previously received ESDM parent coaching?
4. Do parents find the procedures used in the ESDM parent coaching and the ESDM therapist implemented interventions to be understandable, reasonable, efficient and effective?
It is hypothesised that the parents' implementation of the ESDM techniques will improve following the parent coaching and that children's imitation, expressive language, and joint engagement will improve during both the parent coaching and direct therapy interventions. It is also hypothesied that parents will find both interventions understandable, reasonable, efficient, and effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80790 0
Ms Hannah Waddington
Address 80790 0
Victoria University of Wellington
P. O Box 600
Kelburn
Wellington, 6140
Country 80790 0
New Zealand
Phone 80790 0
+64 04 463 6892
Fax 80790 0
Email 80790 0
hannah.waddington@vuw.ac.nz
Contact person for public queries
Name 80791 0
Ms Hannah Waddington
Address 80791 0
Victoria University of Wellington
P. O Box 600
Kelburn
Wellington, 6140
Country 80791 0
New Zealand
Phone 80791 0
+64 04 463 6892
Fax 80791 0
Email 80791 0
hannah.waddington@vuw.ac.nz
Contact person for scientific queries
Name 80792 0
Ms Hannah Waddington
Address 80792 0
Victoria University of Wellington
P. O Box 600
Kelburn
Wellington, 6140
Country 80792 0
New Zealand
Phone 80792 0
+64 04 463 6892
Fax 80792 0
Email 80792 0
hannah.waddington@vuw.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary