PLAIN LANGUAGE STATEMENT To:
Adult Participants Full Project Title:
EVALUATION OF THE PSYCHOMETRIC PROPERTIES OF OLAMIND Principal Researcher(s):
A/Prof Mark Stokes, Rachelle Lavi Approval:
This study has received Deakin University ethics approval (reference number: 2019-430).
Autism spectrum disorder is a neuro-developmental disorder. Autism is diagnosed according to the presence of certain difficulties with social communication together with restricted or repetitive behaviors or sensory sensitives.
Although over 40% of children and adolescents with autism are verbal and have normal intelligence, this group is particularly at risk of being misdiagnosed or missed altogether. The OlaMind system was developed to help to identify the need for full assessment for possible autism in children and adolescents aged 4–18 years. The proposed study seeks to test how well it achieves this.
The study will be recruiting one or both parents/guardians of approximately 260 children and adolescents between the ages of 4 and 18 years who either have or do not have a diagnosis of autism.
Participants will complete a questionnaire that asks about things like the child’s or adolescent’s age, sex, and other diagnoses, about the mother tongue of the child’s mother/parent_1, and how many years of education the parents have. To help the researchers analyze the overall results of the research project, this part also asks two set of questions (identified by the words "Optional question") that seek to identify when different sets of results relate to the same child or to siblings. If you are aware that your child’s other parent/guardian is also intending to participate in this research, you may choose to provide them with the questionnaire number
that will be sent to you by email, for them to pass on to the researchers. This will inform the researchers that your responses relate to the same child. Your responses will in any case remain entirely confidential. It is entirely voluntary whether you choose to share this number, and if you choose not to, then no other person, other than the researchers, will know that you have participated in the research. Similarly, if you are aware that your child’s other parent/guardian has already participated in the research, and they have chosen to share the questionnaire number with you
, the researchers would be grateful if you provided it when answering these questions. Please note that it is entirely voluntary whether any participant shares the knowledge of their own participation with any other person, and in no circumstances will the researchers divulge details of any participants’ involvement in the research. This part of the research will take about 5–10 minutes of your time. Participants will then use the OlaMind system to assess the social communication, restricted and repetitive behaviors, and sensory sensitivities of the child or adolescent. Responses are “Agree” or “Disagree.” This will take about 10–15 minutes of your time. You can spread your answers out over up to seven days if you need to check the child or adolescent’s behavior before answering. When you finish and click ‘send,’ you can choose to view or download a report of the results. A few weeks later, we will send you an email inviting you to complete the OlaMind questionnaire a second time, if you so choose. Parents/guardians of any child or adolescent aged 4 to 18 years may use the OlaMind system, however the study will analyze only data concerning children/adolescents who both speak in sentences and do not have an intellectual disability.
By marking the check-box below, you are stating that you have read and understood this Plain Language Statement and that you agree to participate in the study as described here. If you do not wish to participate, please do not check the box. Since all the questionnaires are digital and you cannot sign that you agree, your agreement will be linked to your email address and IP address. The researchers will not reveal your identity or personal details.
If you have any questions, please contact Rachelle at firstname.lastname@example.org
(in Hebrew or English). If you change your mind about participating, please email us at email@example.com
(in English) or at firstname.lastname@example.org
(in Hebrew or English) asking to withdraw from the study, and we will ensure your data are deleted. Withdrawal WILL NOT jeopardize your relationship with Deakin University or the researchers.
Risks and potential benefits to participants:
No benefits are provided to participants in this study.
There are some risks to parents/guardians associated with participating in this study. Agreeing or disagreeing with statements about your child’s behavior may bring to mind behavior that you have previously found distressing and lead to new reflections that awaken or sharpen a concern that your child may be on the autism spectrum. If you think that this may happen to you, please give careful consideration to whether you wish to participate. To help you decide, one statement and an accompanying example that you will encounter asks you to agree or disagree that your child: has difficulties making and/or keeping friends with others of about the same age.
And gives, as an example, that: others of about the same age that [the child] wants to be friends with mostly do not want to be friends with [the child].
If you decide to participate but later find that you become distressed, you are free to discontinue at any time.
The OlaMind system makes a report available to all participants. Where the OlaMind system detects potentially concerning levels of traits associated with difficulties in social communication, then the report suggests what that may mean and tabulates all concerning traits together with any comments you chose to make. Therefore, reading the report risks awakening or sharpening a concern that your child could be on the autism spectrum. You can choose not to view/download the report. If you choose to view the report and become distressed, please discuss its contents with a trusted healthcare provider, such as your child’s doctor. In the event that the results in the report raise a suspicion of difficulties with social communication such as those seen in the autism spectrum, you may also seek advice from associations that support individuals with autism and their families. These associations, which are entirely unassociated
with the current research, include Alut (open line for parents: 03-6709094) and EffieAsperger Israel (office: 03-5446046).
If you have any complaints about any aspect of the project, the way it is being conducted or any questions about your rights as research participants, then you may contact:
The Manager, Office of Research Integrity, Deakin University, 221 Burwood Highway, Burwood, Victoria 3215, Telephone: (03) 9251 7129, Facsimile: (03) 9224 6581; Email: email@example.com
Please quote Deakin University ethics approval reference number: 2019-430. Thank you