What kinds of tests or assessments will be done on my child?
The assessments will vary based on the study. Some common assessments are reviewing medical history and side effects with a doctor; examining behavior, thinking skills, or symptoms with a psychologist; and checking health with blood draws, urine samples and electrocardiograms.
Does my child need to have a diagnosis already in order to participate in a research study?
No. If your child has not been previously diagnosed, a diagnostic evaluation will be provided to you during the screening process to determine eligibility for a study.
What is the time commitment for being involved with a research study?
The length of a study varies greatly. Some studies may only last a few weeks while others last many months. You will be required to come to the Nisonger Center every few weeks or months for check-ups when participating in research. These visits may last anywhere from 30 minutes to several hours. Details about time commitment for any study you are interested in can be obtained by phone.
Will my child have to miss school to participate in research?
Maybe. A few studies conduct assessments and treatments during the school day, but most are able to offer families several other options for appointment times. Many study sessions can be arranged during after-school (or before-school) hours, and we make every effort to accommodate families’ schedules. Typically a child might miss a day or half-day of school for the screening visit, which is longer than other visits, then have the other appointments before or after school hours.
What kinds of treatments are available for my child?
There are a variety of treatment options. Though specific treatments vary by study, some types of treatments that we have used in the past include parent training, parent education, supplements, and medications. Though the specific treatments being studied change from time to time, they usually include a combination of behavioral and medicinal treatments.
What is the difference between receiving treatment in a study and receiving it from my regular health care provider?
Cost, frequency, and treatment options. Often the treatment(s) in regular care and studies are similar. Because researchers are trying to learn something new (or to confirm something), there may be more standardization and careful attention to quality in research. Assessments may be more frequent than in regular care. Usually, assessments such as safety checks are more thorough than is affordable in ordinary care. Research evaluations and treatments are usually free (and there is often some reimbursement for travel). The more frequent and/or more extensive evaluations may consume more time for the patient than in regular care. Sometimes, treatments offered in studies are novel or not widely available to the public. An example is when new treatments are being evaluated for the first time. Many studies are “controlled.” This means that one subgroup for at least part of the time receives no treatment or a standard comparison treatment. Some studies look at different amounts of treatment in dose comparisons.
Will my child have to stop taking his/her prescribed medication to participate in research at the Nisonger Center?
It depends on the study. For some studies being conducted at the Nisonger Center, your child with be able to continue his/her current medications when participating in the research study. However, for other studies, your child may be asked to discontinue his/her current medication order to evaluate the benefit of the study treatment for your child. You can find out by phone whether the study you are interested in requires stopping current medicine
Can my child be part of a study even if he/she has a serious health problem?
It depends on the study. Though most studies require children to be in generally good health, each child will be evaluated on an individual basis in order to determine eligibility.
If my child participates in a study with medication, how common are side effects and what do I do if I think they are experiencing a side effect?
The frequency and severity of side effects vary from one medicine to another. Most medicines strong enough to help are also strong enough to have side effects. In fact, one of the purposes of most studies is to learn more about possible side effects and how to relieve them. Most side effects are uncommon, although a few “nuisance” side effects (such as effect on appetite) for some medicines affect half or more, at least temporarily. Before you agree to participate in any study, you will be told all the known possible side effects and, if known, how common they are. You will be given the home phone number of a study doctor and the study coordinator so that you can call at any time for advice if a side effect should occur.
Will my child get a placebo (fake medicine or fake treatment)?
Possibly. With some exceptions, most treatment studies have a placebo treatment for part of the time for some of the participants. The chance of getting placebo is usually between 1/4 and 1/2, and it is decided by chance (like throwing dice) who gets it. Those who have placebo in the double-blind part get a chance to try the real treatment afterwards. There are important advantages to having a placebo. Many children improve with placebo treatment because of maturation, increased adult attention, positive expectations, and other helpful things going on in their lives. When this happens, the child is saved the risk of the real treatment. Even if the child does not improve with placebo, there is an important contribution to increased knowledge that can benefit all children with the problem that is being treated, including your child. Without a placebo-controlled study, we could not be sure that the risks and costs of treatment are justified by real benefit.
Will I be paid for participation?
Yes. Payment for participation varies between studies. Some reimbursement is always given for transportation and parking and in most studies the child is given a small prize. You can inquire about the financial details of the study you are interested in by calling the coordinator for that study.
Will choosing to participate or not participate hurt/help my relationship with OSU?
No. Participation/lack of participation has no effect on your relationship with OSU.
What if I (or my child) want to stop participating in the study once we have enrolled?
You and your child have the right to stop participating at any time with or without a reason. However, we request in such cases that you come for a final wrap-up visit.
Will I be penalized for leaving the study early?
What happens if the study intervention is not working for my child?
With any research treatment (or even regular clinical treatment), we cannot guarantee that a particular intervention will help your child. However, by participating in a study, your child will be closely monitored by expert clinicians. These clinicians can help you to devise an alternative treatment plan if you are unhappy with the study treatment. You always have the freedom to withdraw from a study at any time.
Will anyone know I participated in this research? Who will have access to my child’s information?
All of your child’s information is kept as confidential as possible within the federal, state, and university regulations governing research. In cases where the study needs to obtain behavior and performance ratings or other information from the child’s teacher, this will be explained and only done with your permission. In such a case, the teacher will be instructed in the need for confidentiality. Your child’s files will be kept under lock, and the only people who will have access to your child’s information are staff who are directly involved in the study, the study sponsor, and authorities who monitor research activities. There is a system to insure that all research is carried out ethically with concern for participant safety, and those authorities have the right to inspect the records to make sure all the rules are followed. There are special privacy rules regarding this, and these will be explained before you agree to participate. When results of the study are published, information from your child will be combined with information from the other children participating in the study and only group data will be reported in the publication. No identifying information about any of the individual participants (such as initials or birthdate) will ever be published.
How is my child protected?
Before a study starts, it must be reviewed and approved by an Institutional Review Board (IRB), a committee whose main responsibility is to protect the rights and welfare of research participants. We actively cooperate with this committee in order to protect participant safety and well-being.
How soon can you see my child?
Within two weeks. Though our schedules are constantly changing, you are generally able to schedule a screening visit within two weeks of contacting a staff member.
What if I am not interested in any of the current studies but would like to be considered for future studies?
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