Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000490774
Ethics application status
Approved
Date submitted
29/04/2013
Date registered
1/05/2013
Date last updated
8/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Assisting parents of children with autism to make intervention decisions by improving their health literacy about evidence
Scientific title
Assisting parents of children with autism to make intervention decisions by improving their health literacy about evidence
Secondary ID [1] 282414 0
Nil Known
Universal Trial Number (UTN)
U1111-1142-3425
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parents of children with an autism spectrum disorder and intervention decision-making 288996 0
Condition category
Condition code
Mental Health 289342 289342 0 0
Autistic spectrum disorders
Public Health 289373 289373 0 0
Health promotion/education
Public Health 289374 289374 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being trialled is a web-based interactive decision aid, aimed at helping parents of children newly diagnosed with autism to make intervention decisions. The decision aid is a website, which features a questionnaire, that when answered, will provide parents with a list of 'best fit' interventions for their child based on their responses.

The questionnaire is comprised of eight questions, which cover aspects of autism that parents may wish to improve or address. Each question is answered by parents indicating on a 5-point likert scale how important it is for them that the characteristics or behaviours described in the corresponding question be improved or addressed.

Once completed, the top 5 most relevant interventions will be revealed with links to more information on those interventions. The purpose of the questionnaire is to help parents make better informed treatment decisions, with consideration for available research evidence. The website menus will also provide links to further information about 21 interventions, selected for inclusion on the website for having supporting evidence and for being available in Australia.

The interventions selected and described on the website are for children aged less than 7 years who have autism. The website will be accessed primarily by parents and carers of these children.

The website also includes information about autism spectrum disorders, how they are diagnosed, and where parents can obtain further information about the disorder and intervention service providers.

Participants of the study will be asked to access the website for any length of time and any number of times over a 3-month period. During this period, participants will be contacted once to ensure they are able to access the website and have (or are intending to) view the information on the site.
Intervention code [1] 287048 0
Other interventions
Comparator / control treatment
Parents of children with autism allocated to the control group will be required to access typical post-diagnosis support and sources of information about autism interventions (standard care).

When a child receives an autism diagnosis, their parents will typically be advised by their treating health professional to seek a consultation with Autism Queensland, or their relevant state-based autism support agency. An Autism Advisor will provide the family with information about autism, intervention providers, and funding options. They will also assess their eligibility for Helping Children With Autism funding and provide them with a Letter of Introduction which enables them to access approved service providers. Typical support may also include (depending on personal preferences) linking in with parent support groups, specialised playgroups, online forums, attending workshops and reading online and print materials on topics related to autism and autism treatment. Participants will be asked to report on sources of information accessed over a 3-month period.
Control group
Active

Outcomes
Primary outcome [1] 289454 0
The Decisional Conflict Scale (O'Connor, 2010) will be used to determine participant’s self-efficacy with decision-making, factors affecting decision-making, and satisfaction levels in relation to decisions made.
Timepoint [1] 289454 0
3 months post provision of access to the decision aid.
Secondary outcome [1] 302510 0
Parenting Sense of Competence Scale (PSOC) (Johnston & Mash, 1989) will be used to measure parent self-efficacy.
Timepoint [1] 302510 0
3 months post access to decision aid.
Secondary outcome [2] 302512 0
Self-report likert scale measuring parent's level of confidence with decision-making.
Timepoint [2] 302512 0
3 months post access to decision aid.

Eligibility
Key inclusion criteria
Parents of children with an autism spectrum disorder, diagnosed within the past 12 months and aged under seven years. Children must be receiving Helping Children With Autism funding, and live in Australia.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants must meet inclusion criteria as described above. The Gilliam Autism Rating Scale - 2 will be used to ensure participants' children meet diagnostic criteria for autism.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A Random Numbers Table will be generated by an offsite third party who will also allocate participants to either the intervention or control group using this method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
Effectiveness of the decision aid will be evaluated using between group t-tests, Analysis of Covariance (ANCOVA), and regression scores.

With no prior data, assumptions were made to facilitate power calculations. The number of participants required for the study was determined to be 126 (including 10% attrition). This number was required for an effect size of .23, at 80% power with an error probability of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2013
Actual
17/07/2013
Date of last participant enrolment
Anticipated
25/04/2014
Actual
2/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287187 0
University
Name [1] 287187 0
The University of Queensland
Country [1] 287187 0
Australia
Funding source category [2] 287189 0
University
Name [2] 287189 0
The Olga Tennison Autism Research Centre. La Trobe University
Country [2] 287189 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 285950 0
None
Name [1] 285950 0
Address [1] 285950 0
Country [1] 285950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289183 0
Behavioural & Social Sciences Ethical Review Committee (BSSERC)
Ethics committee address [1] 289183 0
Ethics committee country [1] 289183 0
Australia
Date submitted for ethics approval [1] 289183 0
Approval date [1] 289183 0
11/08/2011
Ethics approval number [1] 289183 0
2011000783

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

Contacts
Principal investigator
Name 39638 0
Dr Nicole Grant
Address 39638 0
29 Chesney Street
Carina QLD 4152
Country 39638 0
Australia
Phone 39638 0
+61 417 879 461
Fax 39638 0
+61 7 3843 4084
Email 39638 0
nicole.grant@uqconnect.edu.au
Contact person for public queries
Name 39639 0
Nicole Grant
Address 39639 0
The University of Queensland
Brisbane QLD 4072
Country 39639 0
Australia
Phone 39639 0
+61 417 879 461
Fax 39639 0
+61 7 3843 4084
Email 39639 0
nicole.grant@uqconnect.edu.au
Contact person for scientific queries
Name 39640 0
Nicole Grant
Address 39640 0
The University of Queensland
Brisbane QLD 4072
Country 39640 0
Australia
Phone 39640 0
+61 417 879 461
Fax 39640 0
+61 7 3843 4084
Email 39640 0
nicole.grant@uqconnect.edu.au

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.