Can Stimulant Medications Help Children with Fetal Alcohol Spectrum Disorder and ADHD?

What you need to know

• Fetal alcohol spectrum disorder (FASD) is caused by alcohol exposure during pregnancy and often comes with attention problems.
• This study will test if stimulant medications help improve attention and behavior in children with both FASD and ADHD.
• The researchers will use a special trial design to determine if the medication works for each individual child.

Background on FASD and ADHD

Fetal alcohol spectrum disorder (FASD) is a condition that can occur when a developing baby is exposed to alcohol before birth. This exposure can lead to various developmental problems as the child grows up. One of the most common issues seen in children with FASD is difficulty with attention and hyperactivity. In fact, studies have found that 50-94% of children with FASD also meet the criteria for attention deficit hyperactivity disorder (ADHD).

ADHD is a condition characterized by ongoing problems with paying attention, being overly active, and acting impulsively. These symptoms can significantly impact a child’s ability to function at home and school. While stimulant medications like methylphenidate and amphetamines are commonly used to treat ADHD in children, there hasn’t been much research on how well these medications work specifically for children who have both FASD and ADHD.

Why This Study is Important

Children with FASD may have different underlying brain differences compared to children with ADHD alone. This means that medications that work well for typical ADHD may not have the same effects in children with FASD. Additionally, children with FASD often have more complex needs and may be more sensitive to medication side effects.

Currently, there is very little scientific evidence to guide doctors in prescribing ADHD medications for children with FASD. This study aims to start filling that knowledge gap by carefully testing if stimulant medications actually improve ADHD symptoms in this specific group of children.

How the Study Will Work

The researchers will use a special study design called an “N-of-1” trial. Here’s how it works:

1. Each child in the study will go through multiple 2-week cycles where they take either their usual stimulant medication or a placebo (a pill with no active medication).

2. Neither the child, parents, teachers, nor researchers will know which weeks the child is on the real medication versus the placebo. This helps prevent bias in how the effects are reported.

3. Throughout the 8-week study period, teachers and parents will complete daily ratings of the child’s ADHD symptoms and behaviors.

4. At the end of the study, researchers will “unblind” the results to see how each individual child responded during medication weeks compared to placebo weeks.

This design allows the researchers to determine if the medication is truly helpful for each specific child, rather than just looking at average effects across a group. It also accounts for the fact that children with FASD can be quite different from each other in terms of their symptoms and needs.

What Will Be Measured

The main thing the researchers want to know is if teachers observe improvements in the child’s attention, hyperactivity, and impulsivity when on the medication compared to the placebo. They will also look at:

• Parent ratings of ADHD symptoms
• How well the child functions at home and school
• Any problematic behaviors
• The child’s performance on attention tests
• Any side effects from the medication

Potential Benefits and Risks

If successful, this study could help doctors make more informed decisions about prescribing stimulant medications to children with both FASD and ADHD. For the individual children in the study, it may provide clear evidence about whether the medication is truly helping them or not.

The main risks involve potential medication side effects, which will be closely monitored. There’s also a chance that ADHD symptoms may temporarily worsen during placebo weeks when the child is not receiving their usual medication.

Conclusions

• This study will provide much-needed evidence about whether stimulant medications help children with both FASD and ADHD.
• The special N-of-1 design allows researchers to determine if the medication works for each individual child.
• Results could help doctors and families make more informed decisions about ADHD treatment for children with FASD.

While this is just a pilot study with a small number of children, it’s an important first step in improving care for this unique group of patients. The researchers hope that this work will lead to larger studies and eventually clearer treatment guidelines for managing ADHD symptoms in children with FASD.