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Participant
Information Statement
(1) What is the study about?
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Research towards treating Attention-Deficit/Hyperactivity
Disorder (AD/HD) has focused primarily on pharmacological
options through medications such as Ritalin and Dexedrine.
Less is publicly known about the use of biofeedback with
AD/HD. This study will investigate an area of biofeedback on
AD/HD that has been found to be limited. It will look at the
use of biofeedback through heart rate variability (HRV) and
skin conductance levels (SCL) in helping children manage
their AD/HD. |
(2) Who is carrying out the
study?
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This study is being conducted by
Ms. Krestina Amon and
will form the basis for a PhD degree at The University of
Sydney under the supervision of Dr. Andrew Campbell and Dr.
Gomathi Sitharthan. |
(3) What does the study
involve?
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study will proceed in two parts.
Part I:
Both the
experimental group and the control group will form two
groups. You and your child will be randomly allocated to
either group, which will determine how many sessions you
will attend.
The first group of
AD/HD children will undergo biofeedback sessions once a week
for three months (12 weeks) totaling 12 sessions of 45
minutes in length. And the second group of AD/HD children
will undergo the same biofeedback sessions three times a week
for two months (8 weeks), totaling 24 sessions, also for 45 minutes.
Sessions will each involve a small group of up to two children
undergoing biofeedback testing.
Similarly, the
control group of normally developing children will also
undergo three months of 45 minute sessions once a week
(12 sessions), and the second group of normally developing
children, three times a week for two months (24 sessions) also for 45 minutes.
This study will be
using an off the shelf product called
The Wild
Divine Project. The system will use three plastic
rings which will be placed on your children's fingers, which
will be connected to a computer. Your children will then
proceed though a series of games requiring your child to
play by focusing on certain physiological states, such as
their breathing and heart beats.
Part II:
While the children
are undergoing their biofeedback sessions, you will be asked
to complete an electronic diary asking questions regarding
your children's behaviour, their experience of the
biofeedback technology, and your own health experiences
connected to your child. You will complete four diary
entries; at the first session, the end of the first month of
sessions, end of second month of sessions, and the final
session. Questions will look to determine
any changes seen from your child, your own personal
experiences of stress and coping with your child's behaviour,
and general feedback on the use of biofeedback as a
treatment option for AD/HD.
PLEASE NOTE:
Interested participants are to be able to attend sessions
held at The Faculty of Health Sciences, in The
University of Sydney,
Cumberland Campus, Lidcombe, NSW. Participation
will require interested participants to be able to attend
sessions for a maximum duration of three months.
Click here to see current
availabilities for the next group to start sessions. |
(4) How much time will the
study take?
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Part I: each of the biofeedback sessions will be 45 minutes in length.
The duration of the study will be three months if sessions
are undertaken once a week, or two months when sessions are
attended three times a week.
Part II: the
questionnaires will take you between 15 and 20 minutes to
complete. |
(5) Can I withdraw from the
study?
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Being that this study is completely voluntary, you are not under
any obligation to consent to participate. You may withdraw
form the study at any time without giving reasons and
without consequence. |
(6) Will anyone else know the
results?
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aspects of the study, including results will be strictly
confidential. The researchers will not be able to identify
individuals. Part II of the study will require you to create
a personal 6 alpha-numeric code which will be used on your
questionnaire responses. Your code will be used to identify
your responses to the questionnaire, ensuring anonymity, so
we can remove it form our data collection if you wish to
withdraw from the study.
A report of the
study will be posted on the project website and will be
submitted for publication, but individual participants will
not be identifiable in such a report. |
(7) Will the study benefit
me?
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AD/HD children participating in the study could benefit from
the study with the use of The Wild Divine Project as
a biofeedback system, as it has the potential to improve
attention, impulse control, and speed of information
processing. |
(8) Can I tell other people
about the study?
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may tell anybody about the study. |
(9) What if I require further
information?
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When you have read this information, the research team is
available to discuss it further and answer any questions you
may have. If you would like to know more at any stage,
please feel free to contact us by e-mail at
A.Campbell@usyd.edu.au
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(10) What if I have a
complaint or concerns?
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Any person with concerns or complaints about the conduct of
a research study, can contact the Senior Ethics Officer,
Ethics Administration, University of Sydney by telephone:
(02) 9351 4811; facsimile (02) 9351 6706; or e-mail at
gbriody@mail.usyd.edu.au |
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