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Trial registered on ANZCTR


Registration number
ACTRN12612000461897
Ethics application status
Approved
Date submitted
18/04/2012
Date registered
24/04/2012
Date last updated
24/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Autism early intervention outcomes study
Scientific title
Clinical outcomes of the Early Start Denver Model for pre-school children with Autism Spectrum Disorders
Secondary ID [1] 280353 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 286317 0
Condition category
Condition code
Mental Health 286557 286557 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children receive a minimum of 20 hours a week of intervention using the Early Start Denver Model (ESDM) in a group setting. They also receive 1 hour a week of individual ESDM therapy. The ESDM will be administered for the duration of the children's attendance at the childcare centre. Children will complete assessments on entry to the childcare centre, and then on exit from the centre or at twelve months after entry, whichever occurs first.

The assessments administered at both timepoints will be the Autism Diagnostic Observation Schedule and the Mullen Scales of Early Learning. In addition, parents will be asked to complete a battery of self-report scales: the Social Communication Questionnaire (SCQ), the Vineland Adaptive Behaviour Scale (VABS), the Depression Anxiety and Stress Scale (DASS-21), the Parent Sense of Competence Scale (PSOC), the Quality of Life in Autism Spectrum Disorders Questionnaire (QoLA). These measures are further detailed in the outcome fields of this form.

The ESDM uses teaching strategies that involve interpersonal exchange and positive affect, shared engagement with real-life materials and activities, adult responsivity and sensitivity to child cues, and focus on verbal and nonverbal communication, based on a developmentally informed curriculum that addresses multiple developmental domains, namely Receptive Language, Expressive Language, Social Interaction, Fine/Gross Motor Skills, Imitation, Cognition, Play Skills, and Adaptive Behaviour/Personal Independence.

All therapists are trained on the administration and scoring of the ESDM and must demonstrate and maintain fidelity.
Intervention code [1] 284718 0
Treatment: Other
Comparator / control treatment
There will be two comparator/control groups:
Typically Developing Control Group: Forty typically developing children attending a mainstream preschool will be recruited and complete the same battery of clinical assessments as the intervention group at baseline and after 12 months.
Treatment as Usual Group: Forty children currently diagnosed with ASD from the community will be recruited and complete the same battery of clinical assessments as the intervention group at baseline and after 12 months.

The assessments administered with the comparator/control groups will be the Autism Diagnostic Observation Schedule and the Mullen Scales of Early Learning. In addition, parents will be asked to complete a battery of self-report scales: the Social Communication Questionnaire (SCQ), the Vineland Adaptive Behaviour Scale (VABS), the Depression Anxiety and Stress Scale (DASS-21), the Parent Sense of Competence Scale (PSOC), the Quality of Life in Autism Spectrum Disorders Questionnaire (QoLA). These measures are further detailed in the outcome fields of this form. While the comparator/control groups will receive the battery of baseline and 12-month assessments, they will not receive the ESDM intervention.

Treatment as usual group will not receive ESDM intervention, but will receive whatever interventions the children and family access of their own accord. We will gather this information about any other treatments received during the study period.
Control group
Active

Outcomes
Primary outcome [1] 286989 0
Measure for Autism symptoms (clinical assessment):
Autism Diagnostic Observation Schedule (ADOS: Lord, Rutter, DiLavore, and Risi, 2001)
Timepoint [1] 286989 0
Baseline and after 12 months of intervention
Primary outcome [2] 286990 0
Measure for cognitive level (clinical assessment):
Mullen Scales of Early Learning (MSEL: Mullen, 1995)
Timepoint [2] 286990 0
Baseline and after 12 months of intervention
Primary outcome [3] 286991 0
Measure for Autism symptoms (parent survey)::
Social Communication Questionnaire (Rutter, Bailey, & Lord, 2003)
Timepoint [3] 286991 0
Baseline and after 12 months of intervention
Secondary outcome [1] 297153 0
Measure for Adaptive Behaviour (parent survey):
Vineland Adaptive Behaviour Scale (VABS: Sparrow, Cicchetti & Balla, 2005)
Timepoint [1] 297153 0
Baseline and after 12 months of intervention
Secondary outcome [2] 297154 0
Measure for family coping (parent survey)
Depression, Anxiety and Stress Scale (DASS21- Lovibond and Lovibond, 1995)
Timepoint [2] 297154 0
Baseline and after 12 months of intervention
Secondary outcome [3] 297155 0
Measure for family coping (parent survey)
Parental Sense of Competence Scale (PSOC: Johnston & Mash, 1989)
Timepoint [3] 297155 0
Baseline and after 12 months of intervention
Secondary outcome [4] 297156 0
Measure for family coping (parent survey)
Quality of Life in Autism Spectrum Disorders Questionnaire (QoLASD, Academic Unit of Child Psychiatry, UNSW, 2011)
Timepoint [4] 297156 0
Baseline and after 12 months of intervention

Eligibility
Key inclusion criteria
Have a confirmed diagnosis of Autism Spectrum Disorder
Minimum age
3 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The study consists of three groups; one group of children with ASD receiving ESDM intervention, one group with ASD receiving "treatment as usual" and one group of typically developing healthy children.

Clinical Treatment Group: Nil

Treatment as Usual Control Group: Nil

Typically Developing Control Group: Participants will be excluded if they have an existing diagnosis of an Axis I or II mental health disorder.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285129 0
Government body
Name [1] 285129 0
Partial funding from FASCHIA (The Federal Government Department of Families, Housing, Community Services)
Address [1] 285129 0
PO Box 7576
Canberra Business Centre ACT 2610
Country [1] 285129 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
ICAMHS, Mental Health Centre, Level 1
Liverpool Hospital
NSW 2170
Country
Australia
Secondary sponsor category [1] 283994 0
None
Name [1] 283994 0
Address [1] 283994 0
Country [1] 283994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287146 0
University of New South Wales Human Ethics Committee
Ethics committee address [1] 287146 0
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 287146 0
Australia
Date submitted for ethics approval [1] 287146 0
Approval date [1] 287146 0
08/06/2011
Ethics approval number [1] 287146 0
11132

Summary
Brief summary
Autism Spectrum Disorders (ASDs) are defined in terms of social and communicative impairment co-occurring with repetitive behaviours and restricted interests. The most severely affected individuals fail to develop functional language and show little ability or desire for social interaction. The causes of Autism are not known, although the high concordance rate found in twin studies suggests a strong genetic component. Studies of head circumference and imaging studies of brain morphometry have found evidence of increased brain growth beginning within the first year of life, while functional brain imaging in older children and adults has shown abnormal patterns of interactions between brain regions, possibly related to aberrant connections being laid down during earlier stages of development.

One model relating these early abnormalities in brain development to the characteristic socio-communicative impairments has hypothesised that early low-level deficits in recognition and orientation towards social stimuli leads to lack of social engagement with primary caregivers during infancy, resulting in decreased exposure to the reciprocal social interactions critical for healthy development of brain circuits responsible for normal social behaviour (Dawson 2008). This model implies that intervention should occur as early as possible to normalize the developmental trajectory and avoid downstream effects, and that a key component of intervention may be to compensate for early deficits in social attention by providing interventions with emphasis on social interaction. Early intervention may also be important in order to take advantage of the increased plasticity present in the first few years of life (Dawson 2008). One such early intervention program consistent with these aims is the Early Start Denver Model (ESDM), a comprehensive early behavioural intervention for infants to preschool-aged children with Autism that integrates applied behaviour analysis with developmental and relationship-based approaches (Rogers et al 2009). A recent randomised control trial in the United States demonstrated significant improvements in clinical outcomes for children receiving ESDM (Dawson et al 2010). After the first 12 months, 18- to 30-month-olds with Autism who received the program showed significant gains in visual processing and improvements in language abilities with subsequent gains in IQ and adaptive behaviour as well as being more likely to receive a less severe diagnosis upon re-assessment.

This study seeks to replicate and extend upon the recent positive international findings regarding the benefits of the ESDM model to children with ASD in an Australian context.

References:

Dawson, G. (2008). Early behavioural intervention, brain plasticity, and the prevention of autism spectrum disorder. Development and Psychopathology, 20, 775-803.

Dawson, G., Rogers, S., Munson, J., Smith, M., Winter, J., Greenson, J., Donaldson, A., & Varley, J. (2010). Randomized, Controlled Trial of an Intervention for Toddlers with Autism: The Early Start Denver Model. Pediatrics, 125(1), e17-e23.

Rogers, S.J., Dawson, G., Smith, C.M., Winter, J.M. & Donaldson, A.L. (2009). Early Start Denver Model Intervention for Young Children with Autism Manual. Seattle: University of Washington.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34085 0
Address 34085 0
Country 34085 0
Phone 34085 0
Fax 34085 0
Email 34085 0
Contact person for public queries
Name 17332 0
Professor Valsamma Eapen
Address 17332 0
ICAMHS, Mental Health Centre, Level 1
Liverpool Hospital
NSW 2170
Country 17332 0
Australia
Phone 17332 0
+61296164205
Fax 17332 0
+61296012773
Email 17332 0
angela.rebolledo@sswahs.nsw.gov.au
Contact person for scientific queries
Name 8260 0
Professor Valsamma Eapen
Address 8260 0
ICAMHS, Mental Health Centre, Level 1
Liverpool Hospital
NSW 2170
Country 8260 0
Australia
Phone 8260 0
+61296164205
Fax 8260 0
+61296012773
Email 8260 0
angela.rebolledo@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results