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Below we have described 4 different ways that people act and feel when they
are with other people. Please read each description and rate how much you
are like each one when you are with people using the 7-point scale, ranging
from "not at all like me" to "very like me". Please also circle the letter A, B, C
or D of the description that is most like you.
Score
A. It is easy for me to feel close to people. I feel okay asking people for
help and I know that they will usually help me. When people ask me for
help, they can count on me. I don't worry about being alone and I don't ________
C. I want to be really close to people, but they don't want to get that
close to me. I am unhappy if I don't have people that I feel close to. I
sometimes think that I care about people more than they care about ________
me.
Score
11. I worry that others don't value me as much as I value them. ______
13. I'd rather not have other people depend on me. ______
15. I find that people don't want to get as close as I would like. ______
Thank you for your letter of 22 May 2008, responding to the Committee’s request for
further information on the above research and submitting revised documentation, subject
to the conditions specified below.
The further information has been considered on behalf of the Committee by the Chair,
Vice-Chair and Scientific Adviser.
On behalf of the Committee, I am pleased to confirm a favourable ethical opinion for the
above research on the basis described in the application form, protocol and supporting
documentation as revised.
The favourable opinion is subject to the following conditions being met prior to the start of
the study.
Management permission or approval must be obtained from each host organisation prior
to the start of the study at the site concerned.
Management permission at NHS sites (“R&D approval”) should be obtained from the
relevant care organisation(s) in accordance with NHS research governance arrangements.
Guidance on applying for NHS permission is available in the Integrated Research
Application System or at http://www.rdforum.nhs.uk.
Headquarters
Deaconess House 148 Pleasance Edinburgh EH8 9RS
The final list of documents reviewed and approved by the Committee is as follows:
Statement of compliance
Now that you have completed the application process please visit the National Research
Ethics Website > After Review
You are invited to give your view of the service that you have received from the National
Research Ethics Service and the application procedure. If you wish to make your views
known please use the feedback form available on the website.
The attached document “After ethical review – guidance for researchers” gives detailed
guidance on reporting requirements for studies with a favourable opinion, including:
The NRES website also provides guidance on these topics, which is updated in the light of
changes in reporting requirements or procedures.
We would also like to inform you that we consult regularly with stakeholders to improve our
service. If you would like to join our Reference Group please email
referencegroup@nres.npsa.nhs.uk.
With the Committee’s best wishes for the success of this project
Yours sincerely
pp Mr Nicholas Grier
Chair
20
15
Frequency
10
Mean =9.5186
Std. Dev. =1.81474
0
N =86
6.00 8.00 10.00 12.00 14.00
HbA1c %
10
8
Frequency
Mean =28.56
Std. Dev. =12.963
0
N =50
10 20 30 40 50 60
IIP total raw score
3) Total Anxiety Score distribution histogram
12.5
10.0
Frequency
7.5
5.0
2.5
Mean =6.0603
Std. Dev. =3.52665
0.0
N =86
0.00 2.50 5.00 7.50 10.00 12.50 15.00
20
15
Frequency
10
Mean =2.686
Std. Dev. =2.53104
0
N =86
0.00 3.00 6.00 9.00 12.00 15.00
HADs depression score
5) Substance use (FVOD% + FVA%) distribution histogram
40
30
Frequency
20
10
Mean =9.359
Std. Dev. =12.64927
0
N =65
0.00 10.00 20.00 30.00 40.00 50.00
FVOD +FVA %
20
15
Frequency
10
Mean =-1.6843
Std. Dev. =4.51879
0
N =86
-15.00 -10.00 -5.00 0.00 5.00
total attachment score
Appendix x (b)
(n=86)
score (n=65)
25
20
Frequency
15
10
Mean =0.9711
Std. Dev. =0.08
0
N =86
0.80 0.90 1.00 1.10
log HbA1c
2) Transformed (square root) HADS Anxiety distribution histogram
30
25
20
Frequency
15
10
Mean =0.4826
Std. Dev. =0.27516
0
N =86
0.00 0.20 0.40 0.60 0.80 1.00 1.20
depression +1 log
4) Substance use (FVOD + FVA%) (Square root) distribution histogram
30
25
20
Frequency
15
10
Mean =2.1261
Std. Dev. =2.21685
0
N =65
0.00 2.00 4.00 6.00
substotalsqroot
Appendix xi
ANOVAc
Total .270 38
Total .270 38
b. Predictors: (Constant), reverse back transformed TAS, square root subs, sq root anx,
depression +1 log , log iip
Model Summary
Psychology Department
St John’s Hospital
Howden Road West
Livingston
West Lothian
EH54 6PP
Version 1- 01/04/08
Date Typed:
Extension: 53627 / 53615
Direct Line: 01506 523615
Direct Fax: 01506 523001
Dear Patient,
I am currently carrying out a study at Diabetes Clinics across Lothian. The study is being
carried out in order to help us to understand what things affect the way teenagers manage
their Diabetes. By carrying out this study we hope to be able to offer more effective help to
all teenagers with Diabetes.
At your next appointment I will be in the waiting area asking all the teenagers attending the
clinic if they would like to complete some questionnaires for me. I will be asking you if you
would like to participate. In order to give you time to think about whether or not you would
like to participate, and to help you to understand the study better, I have enclosed an
information sheet for you to read. Please take the time to read this carefully before you make
any decisions.
When you arrive at the clinic you will be given the chance to re-read the information sheet
and ask any questions before you decide whether or not to take part.
Yours sincerely,
Sally Henderson
Trainee Clinical Psychologist
Appendix v
At your next appointment at the Diabetes Clinic you will be invited to complete some
questionnaires. Before you decide if you want to it is important for you to understand
why the research is being done and what it will involve. Please read this form and talk
about it with anyone if you wish. At the clinic you will be approached by the
researcher, a Trainee Clinical Psychologist called Sally Henderson, and asked if you
would like to take part. At this stage you will be able to ask questions if there is
anything that is not clear or if you would like more information. You do not have to
take part if you do not wish to and you will be given time at the clinic to decide
whether or not you wish to take part.
Studies in the past show that the way teenagers have relationships with friends and
family may affect how well they look after their Diabetes. We also wonder if other
things, such as how much alcohol or drugs the person may be using, and how good or
bad their mood is, may also affect the way they look after their Diabetes.
You should complete the questionnaires in the time before and after your appointment
at the Diabetes Clinic. It will take you around 30- 40 minutes to complete the
questionnaires. It is best if you do this alone without help from a parent or carer who
came along with you today. Please answer the questions honestly. The person who
gave you the forms will be around so please check with her if you have any questions
as you go along.
You may wish to discuss any issues or questions that come up with the researcher
during the clinic. The researcher is more than happy to answer any questions. If this
discussion gives the researcher cause to be worried that your mood is quite low or that
you or another young person may be at risk of harm she can let someone who can
help know. If you are under sixteen years old your parent/guardian will be told that
the researcher is contacting someone who can help with the problem. This will only
happen if you discuss such things with the researcher. The information on your
questionnaires will still be kept anonymous and confidential.
At your next appointment at the Diabetes Clinic you will be invited to complete some
questionnaires. Before you decide if you want to it is important for you to understand
why the research is being done and what it will involve. Please read this form and talk
about it with anyone if you wish. At the clinic you will be approached by the
researcher, a Trainee Clinical Psychologist called Sally Henderson, and asked if you
would like to take part. At this stage you will be able to ask questions if there is
anything that is not clear or if you would like more information. You do not have to
take part if you do not wish to and you will be given time at the clinic to decide
whether or not you wish to take part.
Studies in the past show that the way teenagers have relationships with friends and
family may affect how well they look after their Diabetes. We also wonder if other
things, such as how much alcohol or drugs the person may be using, and how good or
bad their mood is, may also affect the way they look after their Diabetes.
You may wish to discuss any issues or questions that come up with the researcher
during the clinic. The researcher is more than happy to answer any questions. If this
discussion gives the researcher cause to be worried that your mood is quite low or that
you or another young person may be at risk of harm she can let someone who can
help know. If you are under sixteen years old your parent/guardian will be told that
the researcher is contacting someone who can help with the problem. This will only
happen if you discuss such things with the researcher. The information on your
questionnaires will still be kept anonymous and confidential.
At your child’s next appointment at the Diabetes Clinic he/she will be invited to take
part in a research study. Before your child decides whether or not to take part it is
important for you both to understand why the research is being done and what it will
involve, therefore you have both been provided with this information to be read prior
to the appointment. At the clinic your child will be approached by the researcher, a
Trainee Clinical Psychologist called Sally Henderson, and asked whether he/she
would like to take part. At this stage you will both be able to ask questions if there is
anything that is not clear or if you would like more information. Your child is under
no obligation to take part.
From previous research that has been carried out, we think that the way teenagers
have relationships with friends and family may influence how they manage their
Diabetes self care routines. We also wonder if other factors, such as how much
alcohol or drugs the person may be using, and how good or bad their mood is, may
also affect the way they look after their Diabetes.
Your child may wish to discuss any issues or questions that arise with the researcher
during the clinic. If this discussion gives the researcher cause to be concerned about
your child’s mood or that your child or another young person may be at risk of harm,
the appropriate services will be notified. You will be informed of this action by the
researcher at the clinic. This will only happen if your child discusses such things with
the researcher. The information on the questionnaires will remain anonymous and
confidential.
CONSENT FORM
I agree that this patient is capable of understanding the reason for participation and any implications.
This patient therefore has the capacity to consent to participation in the above study.
p<.05
FVA Average Secure Fearful Preoccupie Dismissing A-RQ TAS Composite HADS HADS Total IIP
+FVOD % SASSI% Rating Rating d Rating Rating TAS Depression Anxiety score ** =
significant at
FVA+
FVOD % - - - - - - - - - - p<.005
predictors
Table of correlations between
Appendix viii
(p=.486) (p=.904) (p=.001)** (p<.001)**
Dismissing
Rating .036 .158 -.078 .262 .245 - - - - -
(p=.777) (p=.208) (p=.477) (p=.015)* (p=.023)*
A-RQ TAS
.141 -.025 .655 -.724 -.720 -.547 - - - -
(p=.264) (p=.846) (p<.001)** (p<.001)** (p<.001)** (p<.001)**
Composite
TAS .221 .032 .705 -.682 -.750 -.567 .966 - - -
(p=.176) (p=.848) (p<.001)** (p<.001)** (p<.001)** (p<.001)** (p<.001)**
HADS
depression .107 .451 -.291 .285 .280 .154 -.391 -.453 - -
(p=.397) (p<.001)** (p=.007)* (p=.008)* (p=.009)* (p=.156) (p<.001)** (p=.001)**
HADS
anxiety .032 .231 -.322 .492 .443 .173 -.440 -.568 .442 -
(p=.802) (p=.065) (p=.002)** (p<.001)** (p<.001)** (p=.111) (p<.001)** (p<.001)** (p<.001)**
Total IIP
Raw score .089 .454 -.232 .332 .321 .170 -.387 -.407 .422 .467
(p=.590) (p<.001)** (p=.104) (p=.018)* (p=.023)* (p=.239) (p=.005)* (p=.003)** (p=.002)** (p=.001)**
Appendix ix
value)
(p<.001)
(p<.001)
(p<.01)
(p<.05)
*ns= not significant at p<.05 ** within the limits of z score +/- 1.96
1) Transformed (logx) A-RQ Secure scores distribution histogram
Thank you for your letter of 22 May 2008, responding to the Committee’s request for
further information on the above research and submitting revised documentation, subject
to the conditions specified below.
The further information has been considered on behalf of the Committee by the Chair,
Vice-Chair and Scientific Adviser.
On behalf of the Committee, I am pleased to confirm a favourable ethical opinion for the
above research on the basis described in the application form, protocol and supporting
documentation as revised.
The favourable opinion is subject to the following conditions being met prior to the start of
the study.
Management permission or approval must be obtained from each host organisation prior
to the start of the study at the site concerned.
Management permission at NHS sites (“R&D approval”) should be obtained from the
relevant care organisation(s) in accordance with NHS research governance arrangements.
Guidance on applying for NHS permission is available in the Integrated Research
Application System or at http://www.rdforum.nhs.uk.
Headquarters
Deaconess House 148 Pleasance Edinburgh EH8 9RS
The final list of documents reviewed and approved by the Committee is as follows:
Statement of compliance
Now that you have completed the application process please visit the National Research
Ethics Website > After Review
You are invited to give your view of the service that you have received from the National
Research Ethics Service and the application procedure. If you wish to make your views
known please use the feedback form available on the website.
The attached document “After ethical review – guidance for researchers” gives detailed
guidance on reporting requirements for studies with a favourable opinion, including:
The NRES website also provides guidance on these topics, which is updated in the light of
changes in reporting requirements or procedures.
We would also like to inform you that we consult regularly with stakeholders to improve our
service. If you would like to join our Reference Group please email
referencegroup@nres.npsa.nhs.uk.
With the Committee’s best wishes for the success of this project
Yours sincerely
pp Mr Nicholas Grier
Chair