You are invited to participate in a study designed to learn more about the sleep quality and sleep behaviors of children with an ADHD-diagnosis. This project also seeks to examine the impact of children’s sleep quality/sleep quantity on their caretaker’s sleep quality/sleep quantity and parental stress. As a caretaker, your participation is completely voluntary and you must be at least 18 years old. You have the right to deny participation and can discontinue your involvement at any time. Because this study primarily looks at children with ADHD, proof of diagnosis from the child’s licensed pediatrician, physician or psychologist maybe required if you choose to participate. Similarly, proof of the child’s medication and dosage schedule may also be requested, if he/she is prescribed medication.
Purpose of the Study
The purpose of the study is to determine whether or not a difference in sleep hygiene and sleep behaviors exists between three groups of children (age 6-10). The first group’s members all have an ADHD-diagnosis and are continuously medicated during the entire week, while the second group consists of children with ADHD who receive medication on the weekdays but not during the weekend. Youth who do not take medication and do not have an ADHD diagnosis make up the third group. This project’s protocol is designed to afford the researchers an opportunity to conceptualize how parents’ stress levels are affected and how the parent-child relationship is impacted. This is a unique aspect of research because few studies take a deeper look at children who are partially-medicated and simultaneously examines parents’ interactions and perceived stress across a multiple days (Saturday, Sunday, Monday and Tuesday).
Risks Involved with Participation in the Study
As with any research there is the potential for certain risks and inconveniences. If you are pregnant, it is highly recommended you consult with your physician prior to participating, as your normal sleep pattern could potentially be impacted over the four day timeframe you’re asked to record your child’s sleep information. Although considered minimal risk, you will be asked to answer questions about your interactions with your child that might be uncomfortable. You might experience some psychological discomfort or distress when answering potentially emotionally sensitive questions. Additionally, each parent-participant is asked to contact the researchers via email to receive a $20 gift card for participation in Phase II. While there is minimal risk in sending an email, the participant may feel this part of the study is an inconvenience. Similarly, it is not anticipated that the questionnaires will cause you any undue stress, if this does occur, you can choose not to complete the questionnaires, request to not have your data used, and terminate participation in the study at any time. Your participation in this study is voluntary. All reasonable precautions have and will be taken to reduce risk(s) and to provide for your care.
You may or may not benefit directly from participation in this research study. There are no direct health advantages to you or your child for joining, although you are welcomed to information on improving quality of sleep and sleep hygiene for you and your child. The insight we gain from you and your child might help other people with similar experiences in the future. If you complete the online questionnaire at a hospital/medical clinic or in a school setting in which one of our IRB-approved researchers are present and conducting “on-the-spot” recruitment, you will receive compensation of a $20 Target or Wal-Mart gift card at that time. They will provide a tablet or laptop for you to access and complete Phase 1. If you prefer to utilize your own electronic device (i.e., smart phone, laptop, etc.), you can and they will guide you to the secured site. Participants who complete Phase 1 during on-the-spot recruitment will also be informed about Phase 2 and invited to join this component of the study. Phase 2 requires that you be in tune with your child’s sleep behaviors and complete a brief, five minute survey online across (4) days (Saturday, Sunday, Monday and Tuesday). Once completed, you will receive a $20 Target gift card within the following two weeks. Caretakers who are not recruited through the “on-thespot” initiative, yet, participate in Phase 1 (online questionnaire) will be entered into a quarterly raffle for a Target gift card (ranging in value from $50 -$100) and invited to participate in Phase 2.
Right of Withdrawal and Conditions for Early Withdrawal
Your participation in this research study is voluntary. You may choose not to take part or you may withdraw at any time for any reason. In either case, you will not lose any benefits to which you are otherwise entitled.
Alternatives to Participation
The alternative to participating in this study is not to participate. You do not have to join this study.
The information gathered during this study will be kept confidential to the extent that the law allows and will be used only for the purposes described in this form. This information is called “data.” These data may include questionnaires and researcher notes. The records of this research will be kept private on password-protected computers and when in paper form, stored in locked file cabinets. Research records will be accessible only to members of the research team, the institutional review board responsible for protecting human participants, and regulatory agencies. This study’s findings may be presented and published for professional use; however, no identifying information about you will be used in any written or verbal form. Because the study is online, you will be asked to provide your first and last name, zip code and address (if you elect to have a gift card mailed to you). The website is secured and operated by a trusted, licensed company named Qualtrics.
Limits to Confidentiality
As described above, the information you provide in this study will be kept private. However, there are three exceptions to the confidentiality of what you tell to the researcher:
1. If you plan to hurt yourself
2. If you plan to hurt someone else
3. Child abuse or neglect
In the event that what you say to the researcher indicates that you plan to hurt yourself or someone else, the researcher will notify appropriate supervisors to assist in finding services to help you. Child abuse/neglect will be reported to appropriate Child and Family Services Agency.
There is no cost to you for participating in this study.
Treatment and/or Compensation for Study-Related Injury/ Medical Concern
Howard University does not have a program to pay you if you are hurt or have other bad results from being in the study. However, medical care at a local hospital is open to you as it is to all sick or injured people.
Services at the Howard University Counseling Service are available to all currently enrolled Howard University students at no cost. The Howard University Counseling Service can see students by walk-in from 8:00 a.m. to 5:00 p.m. or by appointment, (202) 806-6870. 24-hour emergency services can also be sought via (202) 345-6709 or (202) 714-7471.
In the event that you have any questions regarding your participation in this research study, or about your civil rights as a research participant or about any research-related injury, you can reach the Principal Investigator Dr. Linda Berg-Cross at (202) 806-9459.
If you have additional questions later or if you have questions any time that you would like to discuss with someone other than the investigators of this project, you are free to call the office of the Vice President for Research Compliance, Howard University Institutional Review Board at (202) 865-8597.
You have read the above description of the research project. Anything you did not understand, you reached out and contacted either Brandi Walker or Dr. Linda Berg –Cross. You’ve had your questions answered to your satisfaction. You agree to participate in the above-referenced project.
You acknowledge that the Principal Investigator and/or the Co-Principal Investigator or the website obtaining this consent has provided you with a brief summary of the research project and that you can print a copy of this Informed Consent Form from the Qualtrics website. Please print and keep a copy of this document in case you want to read it again.
Type in your Last Name and First Name in the space below.