Frequently Asked Questions About Research Studies
Mental Health Terms
Referring Provider Info
Frequently Asked Questions
Child & Adolescent Psychiatry research
There are several questions you should ask when considering participation in a research study. Here are some of the commonly asked questions.
|Q:||What are the risks and benefits?|
|Q:||Does my child have to already have the diagnosis before we contact your clinic?|
No. Study participants may or may not have ever been diagnosed prior to their participation in research. Interested individuals will be screened on the phone for eligibility. If a patient enrolls in a study, an extensive interview process will formally determine diagnosis.
|Q:||Is the study covered under my insurance? Will I have to pay for anything?|
Most of our studies have funding that allows us to have patients participate at no cost to the patient or family. However, some studies do not have this option, and regular clinical fees will be charged. In particular, the first visit to our clinic is a regular clinic visit, resulting in charges to you and/or your insurance. Further, expenses related to standard medical care are your responsibility (or the responsibility of your insurance provider or government program). Some third party payers (insurance companies, HMOs, etc.) may not pay for hospitalization, treatments or procedures that are determined to be experimental. If your child requires hospitalization, this will be the financial responsibility of you and/or your insurance company. All costs not paid by your insurance will be your financial responsibility. Please ask about financial arrangements for any study before you become involved in it. Financial counselors are available to discuss insurance, costs and other issues.
|Q:||How will appointments work?|
The majority of appointments will take place at Children's Hospital of Wisconsin. Appointments for some studies may be scheduled at other area locations. Research clinic appointments are held Monday and Thursday afternoons from 1 p.m. to 5 p.m. Scheduling is handled directly through the research personnel.
|Q:||How often will we be seen?|
Appointments vary from once a week to once every other week in most studies. Longer-term studies often begin with visits once a week and change to once every other month over time.
|Q:||What medications might my child receive and what are the side effects?|
Medications vary widely and a decision about an appropriate medication will be made between you, your child and your doctor. Each medication has different side effects, and these side effects will be reviewed with you and your child before you consent to participate in a study. All study participants and their parents are encouraged to ask questions while considering whether or not to participate and throughout study participation.
In general, the medications used to treat the various disorders our research team studies fall into broad categories: mood stabilizers, atypical antipsychotics and antidepressants. Following are brief and general descriptions of these categories and some common and less common side effects. These are not comprehensive descriptions and you are encouraged to contact study staff for more information on medications used in your childÍs research.
Mood stabilizersare used to decrease the excessive states of mania and depression. Side effects vary widely with each medication, but may include upset stomach, nausea, tremors, weight gain, headache and lower white blood cell count.
Atypical antipsychoticsare relatively newer antipsychotics used to reduce symptoms of psychosis, mania and serious behavioral problems. Side effects vary widely with each medication. Common side effects may include headache, weakness, sleepiness, weight gain, tremor and restlessness. Less common side effects may include tardive dyskinesia (repetitive, involuntary movements of face, legs or torso) and neuroleptic malignant syndrome (fever, tight muscles, changes in blood pressure and heart rate, as well as changes in thinking and understanding).
Antidepressantsare used to relieve the symptoms and prevent relapses of depressive episodes. Side effects vary widely with each medication, but may include sedation, constipation, hypotension, tachycardia, weight gain and sexual dysfunction.
|Q:||How do patients receive the study medications?|
Once a patient is assigned a study drug (or randomized), either the medicine will be distributed within the clinic or a prescription will be faxed to the Children's Hospital of Wisconsin Pharmacy. Families then can pick up the medications after their research clinic visit.
Patients and families taking part in the research study will receive ongoing education about the diagnosis and medications through one-on-one time with a physician or other health care provider and written material. Handouts discuss signs and symptoms of your childÍs disorder, possible triggers that may aggravate symptoms and information on medication therapy, possible side effects and when to notify a physician.
|Q:||What age should my child be?|
In order to be included in most clinical trials, children must be at least 3 years old but not older than 17 years and 11 months. Age requirements for our currently active studies can be found atCurrent Research Studies.
|Q:||What will happen to my child when participation ends?|
Your child's care will be returned to his or her mental health care provider. If your child does not have a provider, we will help with the referral process.
|Q:||How can I prepare my child for participation in a clinical trial?|
Preparing for participating in a clinical trial can vary depending on the trial, but there are several things you can do for any trial. First, be prepared to ask questions so that you can make an educated decision about whether or not you would like to participate. Make sure that you take time to read the consent form thoroughly and understand what will be expected of your child as a voluntary participant. Take time to think things over with friends, relatives and loved ones before making the decision to participate. Things to think about include:
|Q:||What is Bipolar Disorder?|
Bipolar Disorderis a serious mental illness characterized by recurrent manic and depressive episodes or a combination of these episodes, referred to as mixed symptoms. These episodes are characterized by extreme elation, elevated mood or irritability, countered by periodic depressive symptoms. These extreme shifts in mood, energy and behavior interfere with normal healthy functioning for the individual and their entire family. Bipolar disorder also is known as manic-depressive illness.
|Q:||What is Schizophrenia?|
Schizophrenia is a serious and complex mental illness characterized by distorted thinking, strange feelings and unusual behavior and use of language. It involves severe, chronic and disabling disturbances of brain functioning.
|Q:||What is Major Depressive Disorder?|
Major Depressive Disorder is a serious mood disorder and medical condition. These mood episodes go beyond ordinary sadness and cause severe impairment in daily functioning. It is also known as clinical depression or unipolar depression.
|Q:||What is Autistic Disorder?|
Autistic Disorder is a serious neurological and developmental disorder that usually appears during the first three years of life. A child with Autistic Disorder appears to live in his or her own world, showing little interest in others and a lack of social awareness. The focus of a child with Autistic Disorder is a consistent routine and includes an interest in repeating odd and peculiar behaviors. Children with Autistic Disorder often have problems in communication, avoid eye contact and show limited attachment to others.