Is My Child Eligible for the TEAM Study?
To participate, a child must:
- Be between 6 and15 years (up to 16 years old)
- Be in good physical health
- Show symptoms of mania and/or bipolar disorder
- Not already have been on 2 or more of the 3 study medications (Lithium, Depakote, Risperdal).
In addition, your child MAY qualify for the TEAM Study if he or she:
- Has a current diagnosis of bipolar disorder (manic or mixed phase) or mania.
- Is currently receiving medication to which he or she is having little-to-no response. (Your child may be taking medicine, but isn’t getting better.)
- Experienced complications while taking medication for bipolar disorder.
- Is experiencing symptoms of bipolar disorder and he/she has never been treated with medication.
If you are unsure or confused about whether or not your child meets the TEAM Study criteria, please contact us, and we will be happy to answer your questions.
TEAM Study Requirements
3 steps determine if your child is eligible for the TEAM Study. They are:
1) Telephone Screen: A short telephone interview with the parent of the child.
2) In-person Screen: A short in-person interview that both parent and child must attend. The interview will take place in our offices at 18 S. Kingshighway, St. Louis, MO 63108.
3) Baseline Interview: An in-person interview from 9 a.m. to 5 p.m. Parent and child must attend the all-day interview. They will be interviewed individually by two of our experienced research nurses. After the interview, we will make a final determination of your child’s eligibility for the TEAM study.
If Your Child is Eligible
Treating Psychiatrist: All children who enter the TEAM study must have a treating psychiatrist. In order for your child to receive treatment, his or her treating psychiatrist must agree to follow the child after study participation is complete. If your child does not have a treating psychiatrist, our research team will be happy to assist you in finding one.
Time commitment: The child may be in the study for either 8 or 16 weeks
Weekly Visits: Parent and child must come in together for weekly visits. This is the most important part of the study, because we will need to check medication side effects and blood levels, as well as your child’s progress. The weekly visit is also when the child’s next dosage is determined and a prescription is written. Weekly visits will take place on a weekday after 1:00 p.m. Once your weekly visit time is determined, you will need to come in on the same day every week for the duration of the study. For example, if you come in for your first weekly visit on Wednesday, all of your weekly visits will take place on Wednesday.
Blood drawing: All children must have blood drawn at the baseline interview, the week-8 follow-up and the week-16 follow-up (if applicable). Some children, depending on their study medication, may need to have blood drawn weekly. The simple procedure will take place at Children’s Hospital in St. Louis, MO, which is within walking distance of our office.
End of Study Assessment: At the end of 8 or 16 weeks, you and your child will complete another all-day, in-person interview. After this interview, your child will be released to his or her treating psychiatrist. The child’s psychiatrist will receive a letter from the study monitor indicating that the child has completed the TEAM study and is now back under his or her care. In addition, the child’s psychiatrist will be provided with a summary of the child’s study treatment.
Six Month follow-up: Six months after the beginning of your child’s study treatment, you and your child will be contacted to complete one final interview with the TEAM research nurses. If your child is at least 10 years old, she or he can complete the interview over the phone. If your child is younger than age 10, you and your child will come to our offices to complete the interview. After the six-month follow-up has been completed, a payment will be mailed to your child for his or her participation. This interview is your final obligation to the TEAM study.
