What is the AWARE study?
AWARE - Autism with ADHD Research on Effectiveness
The purpose of this study is to figure out how well medicines used to treat ADHD (attention deficit hyperactivity disorder) work for children and teens with autism spectrum disorder (ASD).
You will have up to 9 study visits. Most visits can be done by phone or video call over 16 weeks. There is also the possibility for an additional 2-3 weeks if you need to reschedule any visits. These visits include answering questions, blood pressure, pulse/height/weight, reviewing medicines, and talking with your study doctor.
Your child will be assigned to receive one of two types of stimulant medications. The exact medicine will be selected by talking with the study doctor and looking at your insurance. You cannot choose which type your child will receive.
At week 8 of the study, you will be asked if you are happy with the current medicine. This will happen by answering questions and talking with the study doctor. You can continue the medicine if you are seeing improvements. Or you can stop the medicine if there is little or no improvement or side effects. If you decide to stop the study medicine, you will be randomized again. By chance, you will be given the other stimulant medicine (AMP or MPH - whichever one you did not start out using in this study) or to an alpha-2 agonist. If randomized to an alpha-2 agonist, you and the study doctor will select from two options: guanfacine (Tenex, Intuniv) or clonidine (Catapres, Kapvay).
These medicines are FDA approved, except for MPH. MPH is approved for children 6 years and older. The use of MPH in children under 6 is called “off-label”. This means doctors commonly use this medicine to help with ADHD symptoms even though it has not been approved in children under 6. There is some evidence of safety and success in this age group. Because it is common for doctors to prescribe MPH in younger children, it is important to understand how well it works for younger children.
We hope to enroll 500 people across 12 US and Canadian sites.
You will be paid for your time in this research study.
Why?
The goal of this study is to figure out how well commonly prescribed FDA-approved ADHD medicines work in children and teens with ASD. Current ADHD treatment guidelines are based on children with typical development. It is unclear if the guidelines created for the treatment of ADHD is right for children with ASD. Or if new guidelines, specific to ASD need created.
Are there any benefits?
We cannot promise any benefits to you or others by being in this study. Possible benefits to you include closer monitoring than doctors can regularly provide. Along with being in touch with your care team more often. Your care team will be able to follow you closer, review side effects, and change medicines as needed. Possible benefits to others include creating a better understanding for families and doctors of benefits and side effects for medicines used to treat ADHD in children and teens with ASD.
Are there any risks?
Possible risks are only those related to study participation. The main risks of the study are possible loss of privacy and stress from answering study questions.
Medicines used in this study are the same medicines your doctor would give you if you were not part of the study. All medicines may cause some side effects or other reactions.