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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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