Frequently Asked Questions

How do I know if my child is eligible for the study?

Answer
There are certain criteria that your child will need to meet to participate in the study. A member of the research staff will ask you some preliminary questions to determine whether or not your child may meet these criteria. If, after speaking with the research staff, it is determined that your child may be eligible, you and your child will be scheduled to come in for what is called a screening visit.

At the screening visit, you will be asked to read a consent form and a member of the research staff will answer any questions you and your child may have about the study. If you and your child choose to participate and sign the consent form, your child will receive a thorough evaluation. You will be asked questions related to the presence of ASDs and to see of he or she has ADHD symptoms. A clinician will also talk with your child to help determine presence or not of ASD and/or ADHD symptoms. In addition, you will also be asked to complete some questionnaires about your child’s behavior.

As part of the evaluation your child will also receive a physical exam, have medical lab samples drawn, and an ECG. After the screening visit is done, we will review the results of all the information gathered to determine whether it is appropriate for your child to begin receiving treatment as part of the study. If for some reason it is not desirable for your child to continue with the study, our staff will review the results of the assessment with you and assist you in finding more appropriate care.
How long will the study take?

Answer
Your child may be enrolled in the study for up to 34 weeks (families can drop out earlier if necessary). As part of the study, you and your child will be asked to return to the study clinic for up to 16 visits over a period of 34 weeks. The time it takes to complete each visit may vary slightly depending on how well things are going and individual need. Generally, the screening visit may take approximately 5 hours, the baseline visit approximately 2 to 2 ½ hours, and the 10 weekly visits approximately 1 to 2 ½ hours (depending on whether you are assigned to the Parent Training condition or not).

There are two parts: Study 1 and Study 2. Study 1 has the screen visit and the baseline visit, plus 8 visits spread over 10 weeks. The time needed for Study 2 differs depending on how well your child did in Study 1. If he or she did really well, s/he would stay on the treatment, and you would return every 4 weeks for 24 weeks (6 visits). However, if you and the research staff members feel that the treatment(s) in Study 1 were not optimal for your child, the study doctor would work with you to find the best ADHD medicine for your child. Visits might be weekly at first, and they would stretch out to every 4 weeks once the ADHD symptoms seem to be managed well. Study 2 lasts 24 weeks.
What will the assessments be like?

Answer
The nature of the assessments will vary depending on the visit. Visits may include:

• Time spent with the study staff members answering questions and completing questionnaires about your child’s behavior.

• For families assigned to the Parent Training component, parents will receive training about how to interact with their children to manage ADHD behaviors and any behavioral difficulties.

• Time spent with the study physician, who will ask you and your child questions about his or her medical and psychiatric history, perform physical examinations, review possible side effects, and make adjustments to your child’s medication.

• On occasional visits, the study members will do computer tests with your child to see how well he or she performs on tests of attention.

• Periodically, time spent with a nurse who will draw blood, obtain urine samples, and conduct ECG exams.
I have done behavior intervention before, and it has not worked. What makes CHARTS different?

Answer
Behavior intervention can come in many different forms. In CHARTS, we are using a behavior intervention program that we believe will work well for children with autism spectrum disorders plus ADHD and/or compliance problems.

This particular behavior intervention program has been used widely in other research studies and in community treatment settings, and it has led to positive results for children and families affected by ASD plus ADHD and/or compliance problems.

The program follows a specific sequence of behavior intervention strategies and encourages active participation from parents. Parents will work one-on-one with a behavior intervention clinician to develop specific, individualized strategies for their child. If one strategy is not working, the parent and clinician will develop additional ideas for coping with these difficult behaviors.
What if my child receives placebo instead of Strattera (atomoxetine)?

Answer
In order to determine if a drug really works, most treatment studies use a placebo for some of the participants. In most studies (including this one), the chance of receiving placebo is 50% (half of the participants). Whether or not your child will receive placebo is determined by chance—kind of like rolling the dice. This helps us to ensure that there are no major differences between the group of children who receive placebo and those who receive Strattera. The use of placebo is very important in treatment research. Many children improve with placebo treatment because of maturation, increased adult expectations, and other helpful things going on in their lives. This is commonly known as the "placebo effect," and is a useful and reliable kind of event.

By comparing the results from the children with placebo to the children with Strattera, we can tell how much of the improvement with Strattera is "real" and how much is due to the "placebo effect." The information we get from the group of children receiving placebo is an extremely important contribution to increased knowledge about the usefulness of Strattera, and without it, we could not be sure that the risks and costs of Strattera treatment are justified by real benefit. It is important to know that at the end of the Study 1, all children who do not have a good clinical response will have the chance to try treatment with Strattera and/or other medicines if their behavior still requires it.
What is the study schedule?

Answer

After completing a phone interview, one or two visits for the purpose of determining eligibility are scheduled. We refer to this as the "screen." Screen #1 will include an interview with a medical provider [this wouldn’t be with a psychiatrist in Rochester] (separately with parent and child), an assessment of IQ, and a detailed clinical interview by another staff member with the parent to review the child's development in detail. If the study is a good match for the child (all inclusion criteria are met), Screen 2 will consist of a blood draw, an electrocardiogram (EKG) reading, a physical examination, a urine sample, and further evaluations by a psychologist. (If a family lives a long way from our clinic, there is a chance that we would try to fit all screen procedures into one visit.)

We will conduct brief assessments at each weekly clinic visit to rate progress toward meeting your goals and changes in your child’s behavior.

After 10 weeks of clinic visits, all of the questionnaires, interviews, and tests from the Screen visits will be repeated. The blood draw, EKG, urine sample, and physical and psychological examinations also will be repeated.

If your child has a good response in "Study 1" (Screens + 10 weeks; first part of this investigation), monthly visits can be scheduled for "Study 2" (second part of the investigation). If your child does not have a satisfactory response in "Study 1," we would look at a variety of medication options with you, the parents, and continue to follow your child in "Study 2." Depending on the medication response (end of "Study 1) and choice of medicine in "Study 2," we would see you and your child weekly or monthly (or a mix of weekly and monthly) in the second part of the investigation. Naturally, if we are evaluating a new medicine, then we would want to see your child more frequently.
What is PMT?

Answer
Parent Training (PT) has a long history of use in the field of autism and other developmental disorders. PT involves having a clinician work one-on-one with a family to teach specific skills and strategies to address behavioral concerns at home as well as to teach new, adaptive skills. In the CHARTS study, parents meet weekly with a PT clinician for the first 10 weeks of the study and then monthly thereafter. Each session lasts 60-90 minutes, depending upon the content covered, and is highly interactive. The PT materials are adapted to the specific needs of the child and family. In addition to face-to-face meetings, the PT clinician talks with families via phone to address any concerns and also conducts 1-2 home visits.
Is Staterra a new drug?

Answer

Strattera, also known as atomoxetine, was approved by the FDA in 2002 for the treatment of symptoms of attention deficit disorder in typically-developing children ages 6-18. In this study, we are using this medication for the treatment of attention deficit disorder symptoms in children with autism spectrum disorders. So while the drug has been around for over 8 years, we are evaluating its effects with a different group of children.
Is it fair for my child to be on placebo?

Answer

Some people think it is unlucky to be randomly assigned (by chance) to placebo (fake medicine), but in some ways it is actually an advantage. Some children actually improve on placebo without side effects. If this happens, it may not be necessary to try the real medicine with its risks. If they don’t improve, they will still have the opportunity to try the real medicine later in the study. To understand this better, we need to review the reasons for having a placebo in a treatment research study.

It has been well-known for a long time that some people improve significantly from placebo. We don’t know exactly how it works, but brain imaging studies confirm that changes actually take place in the brain. It may have something to do with hope, expectation, and the feeling of being cared for. Increasingly, the clinical literature is recognizing the placebo effect as a valuable treatment in itself. One of its advantages is lack of side effects and other risk.

As good as the placebo response is in itself, it does complicate the study of new treatments. Without a placebo group to compare to, one could not be sure that any improvement observed is really due to the new treatment. Therefore, it is necessary to have a comparison group who get placebo so that the measured placebo benefit can be subtracted from the measured benefit of the active treatment. The difference between placebo and active medication is the specific pharmacological benefit of the medication. Medicines that are no better than placebo should not be widely used because they carry risk without additional benefit.

The reason for using placebo in a study is that we are not sure the medicine is any better than placebo. In this case, atomoxetine has FDA approval as safe and effective for typically developing children with ADHD, but we don’t know how well it works in children with autism spectrum disorders. (Children with autism spectrum disorders respond differently than other children to many medications.) We do know that atomoxetine has some side effects, so those who are assigned to active atomoxetine are getting a real risk with possible but unknown benefit. In this light, one of the investigators has said that if he were going into a study, he would want to be assigned first to placebo to see if he could get a good placebo response without risk, and then if placebo didn’t work, try the real medication.

The double-blind part of this study is 10 weeks, with a half chance of getting placebo. Those who don’t respond by 10 weeks have their medication unblinded, and if it is placebo, they switch to real atomoxetine. A study doctor or coordinator can explain more about how this works. Contact the site nearest you for more information. (OSU -- 614-688-8214; Pittsburgh -- 412-235-5447; Rochester - 585-275-0953)
What happens if my child drops out of the study?

Answer
As with any research, you may withdraw, at any time, your consent for your child’s participation in this research study.

Your decision to withdraw from the study will have no effect on your child’s current or future relationship with the University of Pittsburgh, Ohio State University or the University of Rochester and will not affect your child’s current or future medical care at any affiliated clinics or with any related service providers. If you need a referral to a health care provider the study staff will discuss possible options with you and help you find a provider for your child.

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Frequently Asked Questions