"We found that a carefully diagnosed and carefully selected sample of 3- to 5-year-old children with ADHD can benefit from Ritalin," Laurence Greenhill, MD, tells WebMD. "But because young children are more sensitive to Ritalin side effects, we found a need for close monitoring of any young child taking this medication."
Greenhill, a psychiatry professor at Columbia University and director of pediatric psychopharmacology at New York State Psychiatric Institute, led the NIMH-funded study.
A previous study in older, school-age kids showed Ritalin to have "strong" effects on ADHD.Compared to older children, Greenhill says, "We found half the dose to be most effective, half the number getting really well, and more kids having to deal with adverse events in the early part of treatment."
Greenhill and colleagues report the findings in five detailed articles in the November issue of the Journal of the American Academy of Child and Adolescent Psychiatry.
Why Medicate Preschoolers?
Ritalin is a stimulant medication that can make about 75% of school-age kids with ADHD act like their peers without ADHD. It can also stunt a child's physical development. Why give such a powerful medication to small children?
A major reason is that kids with moderate to severe ADHD already are at high risk of physical harm.
"They have difficult peer relationships due to lack of reciprocity and perhaps aggression. And they are very prone to accidents," Greenhill says. "Many of them were attending emergency rooms with cuts and bruisesbruises and broken bones, because their fearlessness and activity level made life dangerous for them. They had no idea how dangerous it was to lean out a five-story window, or to speed into traffic on their roller skates. One child saw his mother cooking on the stove, and perched on the stove and turned it on to see how hot it would get. They are fearless and reckless."
Another reason for the study is an eye-opening 1999 report showing that about one in 100 preschoolers was being treated with Ritalin for ADHD -- even though the drug is not approved for this age group.
"So the NIMH asked the questions: Is this effective? Is it safe?" NIMH director Thomas Insel, MD, tells WebMD. "We had no data on these questions."
Half of Kids Get 'Strong Positive Effects'
The study didn't simply give kids a generic version of Ritalin to see what happens. The eight-stage, 70-week study gave parents the opportunity to quit at any time. They could either continue with doctor-supervised Ritalin treatment or discontinue the drug.
An early part of the study made parents attend 10 two-hour training sessions to help parents deal with their child's ADHD. For about 7% of the children, Greenhill says, this was enough.
"For the most part, the problems with Ritalin were the same as those most often seen in older kids -- appetite loss, weight lossweight loss, sleep difficulty, stomach aches, and head aches," Greenhill says. "But some had problems with irritability, more tantrums than they had before, and that was hard to interpret. From my experience, that is the kind of rockiness that you see in kids as the medication wears off."
Ritalin had "strong positive effects" in about half the kids, Greenhill says.
"They could have improved a little more -- but it was a help," he notes. "It takes more time and focus and doctor visits if someone is put on medication at that age. They will benefit -- but they will require more supervision."
"The way I see it, the efficacy is there," Insel says. "It is not as strong or robust an effect as we have seen in other randomized trials in school-age kids. If the question is, 'Does this medication work for these kids under age 6?' the answer is yes. It is an effect that is somewhat less than you would see in older kids, and comes with more side effects. But this confers some benefit in at least some of the kids."
Is Ritalin Really Safe in Preschoolers?
Insel notes that ADHD is a severe problem for children. Ritalin can help, he says, but this benefit must be balanced against the risks.
"A lot of kids are on these medications who should not be on them, and a lot of kids would benefit who don't have access to them," he says. "It will require a much closer look at who will benefit and who could just receive some behavioral intervention and just do fine. But when the medications are helpful, the kids who need them should get them. Finding the balance is the issue for us."
Finding that balance will mean learning more about Ritalin's risks for developing minds and bodies. The NIMH study has documented the short-term risks. But the long-term risks aren't yet known.
"You are giving a medication that has powerful neurochemical effects in a developing brain. What does this mean for long-term development? We don't know," Insel says. "It will take some time to know whether there will be some worrisome side effects in the future. But we have to weigh that against the consequences of not treating. Remember, you have a risk for not treating, too."
Indeed, Greenhill notes that kids with ADHD often suffer peer rejection. This is strongly linked to poor school performance and serious problems in the teenage years.
Just because kids won't do what we want them to do is no reason to medicate them, says Leslie Rubin, MD, director of developmental pediatrics at Emory University and director of the center for developmental medicine at Marcus Institute, Atlanta.
"Kids are designed to be active, to run and play and climb and tumble and explore," Rubin tells WebMD. "When you contain kids in a limited space and have them do things that are constrained and dutiful, it may be difficult for them. If kids watch a lot of TV and don't have structured play, this might result in difficulty for kids to respond to structures in preschool programs. The easiest thing to do is give medicines that control the behavior. What is more difficult is to try to understand the child, to work with the child, to provide more structure."
Insel and Greenhill second Rubin's concerns.
"These are tough problems. It's really difficult because this is a disorder the whole family feels," Insel says. "What you want to make sure you do is not write a prescription and just walk away. The medication is helpful but not sufficient. It involves a long-term relationship, including psychosocial intervention and the need for ongoing medical supervision."
Greenhill says that parent training may ultimately prove to be more effective than medication.
"We teach techniques such as the proper balance of rewards to time outs, the methods of being consistent in commands, recognizing good behavior and rewarding it even if it is rare, and not going overboard when a child loses control," he says. "The parent is literally coached in working with the child. They have a small receiver that fits in their ear, and the trainer sits behind a one-way screen and coaches them. It is very helpful."