The Use of Methylphenidate (e.g., Ritalin®) and Other Psychiatric Drugs in Preschool Children

Review by Stuart Teplin, M.D., Developmental-Behavioral Pediatrician

In recent years, there has been a rapidly growing trend for physicians to prescribe psychotropic medications (i.e., medications that are used to alter a patient’s behavior, mood, or ability to concentrate).  In fact, in the Greenhill article noted above, the authors mention that recent studies “have identified a three-fold increase in the prescribing of psychotropic medication to U.S. children ages 2 to 5 years…”  The three articles cited in this review, from journals in the fields of child psychology or child psychiatry, all address this issue from different perspectives.  Copies of these articles are available from the LINK library. 

DeBar and colleagues reviewed comprehensive electronic records over a recent two-year period, of all children, birth to 5 years of age, who were seen in a large Health Maintenance Organization (HMO).  Only about 16% of children identified as having emotional or behavioral problems received psychotropic medications. Of those who did receive these medications, most had significant psychosocial risk factors (e.g., 75% had parents with psychiatric or drug-abuse problems and about 30% had a documented history of abuse).  In addition to being prescribed infrequently in this population, there was also a high likelihood (83%) that the prescribing of medication was done as part of a broader treatment approach that included family psychosocial services.  Approximately 74% of the children who received medication were diagnosed as having attention-deficit hyperactivity disorder (ADHD), vs. only 11% of children who did not receive psychotropic medication. The authors conclude by emphasizing the many unknowns facing physicians and families when medications are prescribed for children so young. They state that more research into behavioral outcomes and potential side effects is necessary. 

Jaswinder and colleagues monitored a very different population.  Their 27 subjects were children with developmental disorders plus ADHD who were started on psychostimulant medications (e.g., Ritalin, Dexedrine, etc.) between 3 and 5 years of age.  Over the 24-month period of the study, psychostimulants were stopped in 3 children (11%) because of side effects, and other medications were added to the psychostimulants in 7 children (26%).  Overall, 74% of the children responded favorably to the medications by 3 months after starting them, and 70% of children were still benefiting from the medications at 12 and 24 months.  Side effects were mild; they occurred in ~60% of children at 3 months, but this percentage had decreased to 30% by 24 months.  The authors concluded that preschool children who have both developmental disorders and ADHD respond to psychostimulants, but need close monitoring because of frequent side effects. 

The final medical article (Greenberg and associates) describes key issues that were raised by a group of 156 clinical investigators who attended an interactive workshop at the annual meeting of the American Academy of Child and Adolescent Psychiatry in 2000.  These researchers were physicians, participants with Ph.D.s, and others, including community advocates. They systematically discussed obstacles and special challenges (ethical, practical, scientific, and regulatory) faced by investigators who attempt to carry out psychopharmacological research in preschoolers.  Here are a few of the obstacles and proposed solutions discussed:

•         Assessment issues: Lack of validity on psychiatric diagnoses in preschoolers makes it difficult to set meaningful inclusion and exclusion criteria for research subjects. Symptoms are less specific in this young age group, so the typical use of behavior rating scales developed for school-age children is problematic. Possible solutions: developing behavior-rating tools specifically for preschoolers, developing assessment strategies that take into account preschoolers’ special developmental issues, including protocol designs that assess both short-term and long-term adverse effects of medications.

•         Ethical challenges: Little data exist as to symptom expression, toxicity of drugs, long-range developmental effects.  etc. in this population. Little is known about non-drug interventions (.e.g., counseling, etc.) in the preschool age range. Possible solutions: inclusion of preschool and developmental specialists in investigative teams during and beyond the planning stages of studies, use of parent advisory groups to provide guidance on issues of developmental appropriateness of consent procedures and evaluation of risk.

•         Regulatory challenges: Although physicians tend to target nonspecific signs and symptoms of preschoolers (e.g., aggressive outbursts), rather than specific diagnoses when making decisions about which preschoolers to treat with medications, the FDA has traditionally worked only with diagnoses (which are more easily definable in adults) when setting requirements for pharmaceutical companies.  Investigators may be hesitant to subject preschoolers to repeated blood tests needed for determining how the drugs are metabolized in the body. Costs of developing drugs for this age group are often higher. Possible solutions: including experts in child psychiatry and psychopharmacology on the FDA’s internal advisory subcommittees, and encouraging the FDA to consider symptom complexes rather than relying only on “diagnoses.”

•         Special challenges: Preschool children can exhibit severe symptoms in one setting but not in another, making clear-cut diagnoses difficult to make.   Most pediatric psychopharmacologic studies lack input from developmental experts.  Preschool children may need breaks for rest periods and special furniture during trials.  Possible solutions: recruiting developmental specialists as co-investigators, modifying protocols to address the special needs of these young children and their families (e.g., more palatable forms of medications).

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