Rochester Probes Drug Therapy, Parent Training for Kids with both Autism, ADHD
June 05, 2008
Throughout the study, researchers will track children to see if their hyperactive behavior becomes less severe and their cooperation improves.
A National Institutes of Health grant awarded earlier today will empower a team of University of Rochester investigators studying if a blend of drug and behavioral therapy can bring relief to the nearly one-fourth of children with autism who also live with symptoms of ADHD, or attention deficit hyperactivity disorder.
The Rochester team is joined by counterparts at Ohio State University Medical Center and the University of Pittsburgh Medical Center. Together, the three sites will split the $3 million dollar award over the next five years to conduct clinical trials testing if a combination of Strattera, the first non-stimulant medicine approved by the FDA for treatment of ADHD, and parent management training techniques can confer help to such kids who are “doubly diagnosed.”
“ADHD is one of the most common co-morbidities associated with autism, and nearly 1 in 600 kids in this country have both conditions,” said Tristram Smith, Ph.D., associate professor of Pediatrics, who will lead the Rochester cohort. “The disorders can be difficult to tease apart. For instance, repetitive behaviors associated with autism might resemble over-activity, or a child who fidgets might simply not understand what others are asking him or her to do. Sorting through this confluence of symptoms in search of the best therapies can be a real challenge.”
Unfortunately, to this point, the best frontline ADHD medicines haven’t worked very well. Many children with autism and ADHD don’t benefit at all, and close to 20 percent suffered side effects that made them quit treatment, leaving only about half who really enjoyed any sort of advantage. Behavioral treatments have proven quite helpful for other challenges faced by children with autism, but they haven’t been tested carefully for their aid for ADHD symptoms.
Since Strattera, manufactured by Eli Lilly and Company, isn’t a stimulant, it works differently from the other ADHD medications available: it blocks norepinephrine – a stress hormone that influences parts of the brain controlling attention and “flight or fight” responses – from being sponged up by cells. That way, more remains in the central nervous system, where it helps boost attention and curb hyperactivity and impulsivity.
“We hope this will bring more help to more children, but again, medication is only half the equation,” Smith said. “We’re eager to gain insight into the effectiveness of pairing two approaches – pharmacology with parent management training. We particularly want to know whether one or the other, or a combination of both, will prove most beneficial to most kids, and we hope that, in the end, we can offer families more choices.”
Parent management training (PMT) teaches moms and dads how to deal with their child’s impulsivity, acting out, inattention or hyperactivity. Ideally, by shifting focus from the child’s negative behaviors to the positive ones, parents help kids learn to be more cooperative, and this in turn helps the kids learn other important skills.
The large, double-blind study will enroll 144 kids (48 at each study site) between 5 and 14 years old. Each child will receive either a placebo or Stattera; he or she will also receive or forgo PMT, thereby creating four unique study groups.
Throughout the study, researchers will track children to see if their hyperactive behavior becomes less severe and their cooperation improves. Cognitive/performance tests will gauge how well they can pay attention to a computer screen (e.g., children will be told to watch a string of changing pictures, and hit the keyboard when they see the witch), how flexible their thinking is (e.g., children will be asked to shift tasks in a shape-sorting game), and if they can delay gratification (e.g., children will told that, if they wait four seconds before pressing a key, a star will appear on screen). Researchers will also test if children are more amenable to cooperating with a parent when intentionally interrupted, as well as if the medication is well-tolerated.
Smith, principal investigator for the trial, will work in conjunction with co-principal investigator Susan Hyman, M.D., and co-investigator Jennifer Zarcone, Ph.D. Smith, Hyman, and Zarcone work together in the University of Rochester Medical Center’s pediatric Division of Developmental Disabilities.
For more information, or to enroll at the Rochester site, contact study coordinator Carol Stamm at (585) 275-0953, or Carol_Stamm@URMC.Rochester.edu.