AWARE: Management of ADHD in Autism Spectrum Disorder
The AWARE study is a research project looking into the best ways to treat ADHD in children and teenagers (aged 4-17) who also have autism. Many children with autism also experience ADHD, and it can be tricky to find the right medication for them, as they often react differently to treatments compared to others. This study will compare two common ADHD medications, methylphenidate and amphetamine, and also look at another type of medicine called alpha-2 agonists. The goal is to provide clearer guidance for doctors and parents on which medications to try first, so children can get effective treatment sooner and avoid trying many different medicines without success. This will hopefully improve the lives of children and their families.
At a glance
What is this study about?
Many children with autism spectrum disorder (ASD) also have attention deficit/hyperactivity disorder (ADHD). This can make it challenging for them and their families, as well as their doctors, to manage their symptoms effectively. It's often difficult to figure out which ADHD medications will work best for children who have both autism and ADHD, because they might react differently to treatments compared to children who only have ADHD.
Currently, there aren't clear recommendations or guidelines for doctors and parents to help them choose the best medication options. This means families sometimes go through a long process of trying different medicines that don't quite work, which can be frustrating and make things harder for the child. The AWARE study aims to change this by gathering important information that could lead to better treatment plans.
This study will compare common ADHD medicines like methylphenidate and amphetamine, and also look at a newer group of ADHD medicines called alpha-2 agonists. By carefully studying how children with autism and ADHD respond to these treatments, the researchers hope to provide better advice for doctors and parents. Ultimately, the goal is to make sure children get the most effective treatment for their ADHD symptoms as quickly as possible, improving their quality of life.
Key takeaways
- The study compares common ADHD medicines for children with autism.
- It aims to find better ways to treat ADHD in children with autism.
- Participants are aged 4-17 with both autism and ADHD.
- Parents play a key role in reporting on medication effectiveness.
- The goal is to improve guidance for doctors and parents.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, participants need to be between 4 and 17 years old. They must have a confirmed diagnosis of both autism spectrum disorder (ASD) and attention deficit/hyperactivity disorder (ADHD). It's also important that they can take medication consistently, whether it's a pill, liquid, or mixed with food.
A parent or guardian who spends a lot of time with the child must be able to regularly report on how the medication is working. If the child is already taking other common mental health medications (like SSRIs, certain antipsychotics, or epilepsy drugs), the dose needs to have been stable for at least 4 weeks, with no planned changes during the study. Also, the child must not have taken any ADHD medication in the past 7 days.
Children will not be able to join if they have taken ADHD medication in the last 7 days, if their current medications haven't been stable for 4 weeks, or if their doctor thinks taking the study medications might not be safe for them. The study welcomes children with all levels of learning ability, as ADHD in autism affects everyone differently.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child between 4 and 17 years old?
- Does your child have a confirmed diagnosis of autism spectrum disorder (ASD)?
- Does your child also have a confirmed diagnosis of ADHD?
- Can your child consistently take medication (e.g., pill, liquid, mixed with food)?
- Has your child not taken any ADHD medication in the last 7 days?
- Are you able to provide regular feedback on your child's medication?
What does participation involve?
If you decide to take part in the AWARE study, your child will be given one of the ADHD medications to try. The study uses a special method to decide which medicine your child receives, and you might hear it called a 'randomised study'. This helps compare the medicines fairly. You, as a parent or guardian, will play a key role in telling the study team how your child is doing on the medication.
Every two weeks, you'll be asked to rate how well you think the medication is working for your child. Once a month, you'll complete some questionnaires about your child's behaviour and how they are responding to the treatment. This will involve you talking with your child and observing their behaviour, then sharing this information with the study doctors.
If the first medication isn't working well enough, the study team might suggest trying a different medication, either another stimulant or an alpha-2 agonist. The total length of time your child would be involved in the study will depend on how they respond to the medications, but it will involve regular check-ins and assessments for a period of time.
Potential risks and benefits
Locations (12)
- University of California, IrvineVerified postcodeIrvine, United States· Recruiting
- Children's Hospital Los AngelesVerified postcodeLos Angeles, United States· Recruiting
- Maine Medical CenterVerified postcodePortland, United States· Recruiting
- Massachusetts General Hospital Lurie Center for AutismVerified postcodeBoston, United States· Recruiting
- University of RochesterVerified postcodeRochester, United States· Recruiting
- Cincinnati Children's Hospital Medical CenterVerified postcodeCincinnati, United States· Recruiting
- Nationwide Children's HospitalVerified postcodeColumbus, United States· Recruiting
- Children's Hospital of PhiladelphiaVerified postcodePhiladelphia, United States· Recruiting
- University of PittsburghVerified postcodePittsburgh, United States· Recruiting
- University of VirginiaVerified postcodeCharlottesville, United States· Recruiting
- University of Alberta, Glenrose Rehabilitation HospitalVerified postcodeEdmonton, Canada· Recruiting
- Holland Bloorview Kids Rehabilitation HospitalVerified postcodeToronto, Canada· Recruiting
Common questions
What is ADHD in autism?
ADHD (Attention Deficit/Hyperactivity Disorder) means having difficulties with attention, hyperactivity, and impulsiveness. When a child has both autism and ADHD, they show symptoms of both conditions.
What kind of medications will my child try?
Your child might try a stimulant medication (like methylphenidate or amphetamine) or an alpha-2 agonist. These are common and approved medications used to treat ADHD.
Will my child get the same medication everyone else gets?
No, this study uses a special method where participants are randomly assigned to one of the medications being tested, so it won't be the same for everyone.
What is expected of me as a parent?
You'll be asked to observe your child's behaviour and tell the study team how you think the medication is working by completing questionnaires every two weeks and monthly.
Can we stop participating if we want to?
Yes, you have the right to withdraw your child from the study at any time, for any reason, without it affecting their other medical care.
How to find out more
Amanda James, BS
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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