ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Public Health

Health promotion/education

Public Health

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]

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]

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]

3 months post provision of access to the decision aid.

Secondary outcome [1]

Parenting Sense of Competence Scale (PSOC) (Johnston & Mash, 1989) will be used to measure parent self-efficacy.

Timepoint [1]

3 months post access to decision aid.

Secondary outcome [2]

Self-report likert scale measuring parent's level of confidence with decision-making.

Timepoint [2]

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

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Queensland

Address [1]

The University of Queensland
Brisbane QLD 4072 Australia

Country [1]

Australia

Funding source category [2]

University

Name [2]

The Olga Tennison Autism Research Centre. La Trobe University

Address [2]

School of Psychological Science
La Trobe University
Bundoora Victoria 3086

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Behavioural & Social Sciences Ethical Review Committee (BSSERC)

Ethics committee address [1]

Behavioural & Social Sciences Ethical Review Committee (BSSERC)
UQ Research & Innovation
Cumbrae-Stewart Building (72)
THE UNIVERSITY OF QUEENSLAND QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/08/2011

Ethics approval number [1]

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

Dr Nicole Grant

Address

29 Chesney Street
Carina QLD 4152

Country

Australia

Phone

+61 417 879 461

Fax

+61 7 3843 4084

nicole.grant@uqconnect.edu.au

Contact person for public queries

Name

Nicole Grant

Address

The University of Queensland
Brisbane QLD 4072

Country

Australia

Phone

+61 417 879 461

Fax

+61 7 3843 4084

nicole.grant@uqconnect.edu.au

Contact person for scientific queries

Name

Nicole Grant

Address

The University of Queensland
Brisbane QLD 4072

Country

Australia

Phone

+61 417 879 461

Fax

+61 7 3843 4084

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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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