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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
Gender
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
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)
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
Address [1] 287187 0
The University of Queensland
Brisbane QLD 4072 Australia
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
Address [2] 287189 0
School of Psychological Science
La Trobe University
Bundoora Victoria 3086
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
Behavioural & Social Sciences Ethical Review Committee (BSSERC)
UQ Research & Innovation
Cumbrae-Stewart Building (72)
THE UNIVERSITY OF QUEENSLAND QLD 4072
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
The project aims to test the effectiveness of an interactive, web-based decision aid for parents of children diagnosed with autism via a randomised controlled trial (RCT).

METHOD
Following interview and baseline administration of outcome measures, participants who are randomly allocated (using a pre-prepared random numbers table) to the Intervention Group will receive the web-based/electronic educational intervention/ decision-aid. Participants in the Control Group will receive usual care (that is, standard information from autism advisors and other professionals as currently occurs. Three (3) months following baseline assessment, outcome measures will be readministered to all study participants, and interviews once again conducted to obtain information about decision-making processes and choices made regarding interventions. On completion of data collection for the trial, parents in the Control Group will be offered the opportunity to receive the educational intervention.

PARTICIPANTS
150 parents/ carers of children newly diagnosed with autism will be invited to participate in the trial (N=75 per group). Participants will be sourced from all Australian states and territories, and will be parents (most likely mothers) of a child (or children) who is/are less than 7 years old and who has been diagnosed with an Autism Spectrum Disorder (ASD) within the past 12 months. To account for anticipated attrition, 10 additional participants will be recruited to each group. Participants will be recruited via newsletters and websites of ASD organisations in each state and territory, in addition to early childhood/ special education facilities, and other support agencies for children with autism spectrum disorders.

INSTRUMENTS
To ensure that the children of participants meet the diagnostic criteria for ASD, parents will be asked to complete a parent report diagnostic tool called the Gilliam Autism Rating Scale (GARS). Demographic data (e.g. age, gender, educational level, household income bracket, length of time since child’s diagnosis)) will be collected for each participant, and a telephone interview conducted before and after the trial to obtain information about which autism interventions had been considered/ trialled and reasons for the selection of various interventions. Health literacy levels will also be measured using the REALM.

The primary outcome measure will be the Decisional Conflict Scale (DCS) (O'Connor, 1993 (updated 2010)). It will measure participant’s self-efficacy with decision-making, factors affecting decision-making, and satisfaction levels in relation to decisions made (O'Connor, 1993 (updated 2010)). Because this scale will be used to measure decision-making before and three months following receipt of the intervention, responsiveness to change is relevant. The DCS requires participants to read and respond to 16 items across five (5) subscales (Informed, Values Clarity, Support, Uncertainty, and Effective Decision), by ticking boxes marked Strongly Agree, Agree, Neither Agree Or Disagree, Disagree and Strongly Agree.

Secondary outcome measures will be a Likert scale measuring self-efficacy specifically for accessing educational information, and the Parenting Sense of Competence Scale (PSOC) (Johnston & Mash, 1989). This tool contains 16 items across two scales, which address parents' perceived competence, problem-solving ability, capable parenting, value/comforting, and parental frustration, anxiety and motivation. This self-report tool will be used to evaluate parent efficacy and satisfaction before and three months post trial.

DATA ANALYSIS
Statistical software will be used to calculate between-group differences post-intervention (using either paired t-tests or ANCOVA) and regression coefficients will be used to determine which predictor variables (such as intervention, parental level of education etc) influence decisional conflict (decision-making) as the outcome variable.

ADDITIONAL INFORMATION
Upon completion of the study, it is anticipated that information regarding this resource, if proven effective in improving parents' ability to make informed decisions, will be distributed by the health professional or health care team involved in supporting parents during and after autism diagnosis. The resource will also be made available freely online. The website hosting the decision-aid will be optimised to ensure that parents seeking information on the internet using frequently used keywords, will find the relevant webpage within the top search results.
Trial website
www.autismdecisionaid.com.au
Trial related presentations / publications
Grant, Nicole Elizabeth (2016). Assisting parents of children with autism to make intervention decisions by improving their health literacy about evidence PhD Thesis, School of Health and Rehabilitation Sciences, The University of Queensland. doi:10.14264/uql.2016.218
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
Dr 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
Dr 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
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