Medicating children diagnosed with Attention Deficit Hyperactivity Disorder is one of the thorniest ethical issues in pediatric medicine. Now research by ADHD specialists at Duke and elsewhere stands to make it even tougher, suggesting that drugs such as Ritalin work to ease symptoms in toddlers as young as 3.

"We saw kids who had been kicked out of multiple preschools, parents who had not been to a restaurant or out shopping for months or years because they could not control their children, and these kids got better," said Scott Kollins, a child psychologist who led Duke's portion of the clinical trial.

It is the first large national study to examine the safety and efficacy of ADHD drugs in very young children.

"It's very clear that there's a set of kids for whom this is going to be important," said Kollins, director of Duke's ADHD Program.

The findings, published in this month's Journal of the American Academy of Child and Adolescent Psychiatry, have the potential to influence the prescribing habits of pediatricians and family doctors.

Some critics of medicating children worry the study could further swell an already high number of prescriptions for preschoolers. An article in the Journal of the American Medical Association estimated in 2000 that as many as 200,000 preschoolers were taking medicine for ADHD.

"You'll probably see more people willing to prescribe it," said Paul Brinich, a child psychologist and adjunct professor in the UNC-Chapel Hill School of Medicine's departments of psychology and psychiatry. He said most children he sees can resolve symptoms with lifestyle changes and behavioral therapy.

Younger patients

Kollins said the drug study in toddlers was a direct response to concerns about prescribing to ever-younger patients. Drugs now on the market to treat ADHD are technically approved for use only in children age 6 or older, though prescribing to younger kids is not against the law.

"People were doing this already, and they were doing it in the absence of any good clinical evidence," Kollins said.

About 8 percent of children are diagnosed with ADHD nationally, and about 3 percent of preschoolers may have it, according to the U.S. Centers for Disease Control and Prevention. The diagnosis is slightly more common in North Carolina, where nearly 10 percent of children are thought to have it, according to the CDC. There are no state data estimating ADHD in preschoolers.

Just over 6 percent of children between the ages of 4 and 17 are on medication for ADHD, according to CDC. That puts North Carolina in the top five nationally. The new drug study, which had 183 children between the ages of 3 and 5 take a generic form of Ritalin for about a year, provides the first assurance that the treatment is safe for use in children younger than 6, Kollins said.

"We can be confident we're not harming these children and we're probably helping them," he said.

Evidence that methylphenidate, the generic form of Ritalin, benefits younger children is hardly conclusive, however.

Researchers observed that the 3- to 5-year-olds did not show as much improvement on medication as older children did. And younger children appeared slightly more sensitive to side effects such as loss of appetite, difficulty sleeping, irritability and nervous tics. About 11 percent of children in the study dropped out because of side effects. Kollins said the findings suggest younger children on ADHD medicines should be monitored especially closely.

Researchers plan to follow children who participated in the study for a full five years to assess longer-term effects.

The use of ADHD drugs in older children also remains controversial. Earlier this year, a U.S. Food and Drug Administration advisory panel recommended stricter warnings on stimulant drugs such as Ritalin, Adderall and Strattera after a handful of children taking those drugs died suddenly of heart attack or stroke.

One family's success

Alyssa Bickler, whose daughter Alexandra participated in the Duke ADHD trial, wasn't crazy about putting her 3-year-old on a powerful prescription stimulant. But at the time, Bickler and her former husband had run out of ideas to control their daughter's behavior.

Alexandra couldn't go into a store without running away and hiding, Bickler said, and teachers at her Raleigh preschool reported she could not participate in group activities. Even the instructors at the girl's toddler tumbling classes suggested maybe Alexandra wasn't suited to the activity, Bickler said.

Bickler said her daughter's behavior improved dramatically when she began taking the study medication. Bickler remembers tearing up while shopping at a clothing store when Alexandra sweetly pointed out a pair of pants.

"We were having a positive interaction in a store for the first time in her life," Bickler said.

When Alexandra's participation in the study ended, Bickler went to her pediatrician for a prescription and has kept her daughter on medication ever since. She said it has enabled Alexandra, who is now 8, to function well in school, make friends and maintain more positive relationships with her parents.

"Maybe some kids can be treated differently and that's fine," said Bickler. "My daughter responds well to medication."

Multiple treatments

Still, study authors do not recommend medication alone as a cure-all for ADHD.

During the trial, investigators followed strict criteria to limit access to medication, providing it only to children with severe ADHD who failed to show improvement with behavior modification therapy. And even when medication is prescribed, Kollins, who as a psychologist does not prescribe drugs, recommends it be part of a treatment plan that also includes other approaches.

"I certainly would do everything I could not to have my child take medicine unless it was absolutely necessary," Kollins said.