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The
Duke Early Childhood Study
The
purpose of this study is to understand more about the emotional
and behavioral problems that young children
have. We want to understand how worries and fears might affect
children’s
lives at home and outside of the home. To understand how
these problems develop, we need to talk with a large number
of parents and children.
Some of these young children will have problems, but many
will not. You and your child are being asked to take part
in this study because
you participated in the Duke Preschool Child Study. In that
study, we interviewed you twice about your child. In the
past 2 years, you
may have already participated in the Duke Early Childhood
Study (DECS). In the DECS, we are continuing to follow the
children and families
who participated in the Duke Preschool Child Study so that
we can learn how young children’s emotions and behaviors develop
as they grow up. We would also like to be able to contact
you in the future to ask if you and your child would agree
to participate in other studies as your child continues to
grow and develop.
In this phase of the study, we will interview you about your
child’s feelings and emotions as we did in the previous study.
We would also like to speak with your child directly about
his/her emotions and feelings, how he/she gets along with his/her
family,
friends, and how he/she gets along at school. At this visit
we will ask you to fill out questionnaires about your child, about
being a
parent, and about your own emotional experiences, as well
as complete an interview about your emotions.
WHAT IS INVOLVED IN THIS STUDY?
If you and your child take part, two trained interviewers
will talk to you and your child either at home or at
our offices at Brightleaf Square in Durham, whichever you prefer.
We
expect to be
able to complete our tasks in one session. We will schedule
a time to return to your home (or meet you in our offices)
another time if
we are not able to complete all of the tasks in one meeting.
The tasks involved in this study are described below:
1. We will interview you and your child separately using the Child
and Adolescent Psychiatric Assessment (CAPA), an interview about children
older than 7 years. You will be interviewed with the parent version
of the CAPA, and your child will be interviewed using the child version
of the CAPA. We plan to have one interviewer talk with you, while
another interviewer talks with your child. This part will take 1 1/2
to 2 hours to complete.
2. We will ask you to complete a number of questionnaires about your
child. The purpose of these questionnaires is to get a broad picture
of how your child behaves and feels in a variety of situations. We
will also ask you to fill out questionnaires about your own emotions
and about the experiences and stress of being a parent. These questionnaires
will take about 30 to 40 minutes to complete.
3. We will also interview you about your own emotions and feelings.
This part will take about 30 to 40 minutes to complete.
4. If you and your child have not taken part in this study
in the past 2 years, we will conduct a developmental questionnaire
with your child to determine his/her language and reasoning.
Tasks include pattern recognition, pattern recall, and
word recognition. This will take about one hour to complete.
5. We will ask you to name
a teacher whom we can talk to about your child’s school behaviors
and any possible problems that your child may be having there.
6. We will contact you
by phone once every three months to complete a short 13 question
survey about your child ’s emotions.
Before the interview begins, we will ask your permission to use digital
voice recording equipment to record the interview. The voice recordings
will be identified by an ID number only. These digital voice recordings
will be destroyed at the end of the study.
HOW LONG WILL PART TWO OF THIS STUDY TAKE?
We will spend 2 1/2 to 3 hours with you and your child during
this visit.
WHAT ARE THE RISKS OF THE STUDY?
The risks of this study are the discomfort that some people
feel when answering questions about personal or emotional subjects.
There are no physical risks associated with this study. There is,
however, the potential risk of loss of confidentiality. Every effort
will be made to keep your information confidential, however, this
can not be guaranteed. Some of the questions we will ask you and
your child as a part of this study may make you feel uncomfortable.
You may refuse to answer any of the questions, and you may take
a break at any time during the study. You and your child may stop
your participation in this study at any time.
If an interviewer finds evidence of a suicidal or homicidal threat,
child abuse or neglect, the following emergency procedures will be
implemented:
1. A child psychiatrist (either Dr. Adrian Angold or Dr.
Helen Egger) will review the material. If we are concerned about a
suicide or homicide risk, we will offer you and your child a referral
to the appropriate agency for help.
2. If there is evidence of abuse or neglect, the necessary Child
Protective Services report will be filed with the Department of Social
Services.
In most cases where there is a suicidal/homicidal threat or abuse/neglect
concern, you and your child will also be offered a referral to the
appropriate agency. These procedures would not take place without
discussing them with you and your family first.
WHAT ABOUT COMPENSATION?
We will compensate you for the time that the assessments
take. You will receive $65 after you have completed the assessments.
Your child will receive $25 for his/her participation.
WHAT ABOUT YOUR RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM
THE STUDY?
You or your child may choose not to be in the study. If you and your
child agree to be in the study, you or your child may withdraw from
the study at any time. If you or your child withdraws from the study,
no new data about you or your child will be collected for study purposes
unless the data concern an adverse event (a bad effect) related to
the study. All data that have already been collected for study purposes,
and any new information about an adverse event related to the study,
will be sent to the study sponsor.
You and your child’s
decision not to participate or to withdraw from the study will not
involve any penalty or loss of benefits to
which you and your child are entitled. It will not affect
your access to health care at Duke University Health System (DUHS).
If you and
your child do decide to withdraw, we ask that you contact
Dr. Angold in writing and let him know that you are withdrawing
from the study.
His mailing address is DUMC Box 3454 Durham, NC 27710.
Project Coordinator: Brian Small
(919) 687-4686 Ext 274
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