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The Preschool Health and Wellbeing Study

      The purpose of the study is to understand more about the emotional and behavioral problems that very 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.

WHAT IS INVOLVED IN THIS STUDY?

If you take part, a trained interviewer will talk to you either at home or at our offices at Brightleaf Square in Durham, whichever you prefer. We will interview you about your child, yourself, and your family. Your child does not need to be present at this interview. As your child grows and develops, we would also like to contact you in the future to ask if you and your child would agree to speak with us again.


The tasks involved in this visit are described below:

1. We will interview you about your child using the Preschool Age Psychiatric Assessment (PAPA), which is an interview for parents of children ages 2 - 5 years. Before the interview begins, we will ask for your permission to digitally record the interview. These digital recordings (identified by an ID number only) will be destroyed at the end of the study. Recording is used only for evaluating interviewer competence and for review of the information collected to determine the ratings.


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.

3. We will ask you to fill out questionnaires about your own emotions and about the experiences and stress of being a parent.

We will ask about half of the parents who complete this interview to participate in an observational assessment with their child at our offices. If you are asked to participate in this part of the study, we will ask for your consent again.

HOW LONG WILL PART TWO OF THIS STUDY TAKE?

We will spend two to two and half-hours with you during this visit.

WHAT ARE THE COSTS?

There will be no cost to you or your insurance for taking part in the study.

WHAT ABOUT COMPENSATION?

We will compensate you for the time that the assessments take. You will receive $75 after you have completed the interview. If you are asked to take part in the second part of this study you will receive $100 after you have completed the tasks at our office in Brightleaf Square.

WHAT ABOUT YOUR RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM THE STUDY?
If we ask you to be in any other part of this study, we will ask again for your consent to join in that part of the study. Even if you don’t want to be in the other parts of the study, it will still be very helpful to us if you would be in this part

You may choose not to be in the study, or, if you agree to be in the study, you may withdraw from the study at any time. If you withdraw from the study, no new data about you 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.

Your decision not to participate or to withdraw from the study will not involve any penalty or loss of benefits to which you are entitled, and will not affect your access to health care at Duke. If you 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: Box 3454, Duke University Medical Center, Durham, NC 27710.

WHOM DO I CALL IF I HAVE QUESTION OR PROBLEMS?

For questions about the study or a research-related injury, contact Dr. Adrian Angold at 919-956-8496 or (919) 687-4686 ext 228.

For question about your rights as a research participant, contact the Duke University Health System Institutional Review Board (IRB) at (919) 668-5111.

Project Coordinator: Brian Small
(919) 687-4686 Ext 274

 

 

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