WASHINGTON – Behavior modification can reduce the level of medication needed in school-aged children with attention-deficit hyperactivity disorder, William E. Pelham Jr., Ph.D., said at the annual meeting of the Association for Behavioral and Cognitive Therapies.
Few studies have addressed the issue of how behavioral and pharmacologic therapies should be sequenced in children, said Dr. Pelham, a professor of pediatrics and psychiatry at the State University of New York, Buffalo.
Dr. Pelham and his colleagues have completed two studies funded by the National Institutes of Health that examined dosing and sequencing of behavior modification and medication. “We measured impairment–not core symptoms–because impairment is what you want to focus on; that is what causes the most problems for kids,” said Dr. Pelham, who is also a professor of psychology at the university.
The first study included 154 children aged 5–12 years (130 boys and 24 girls) who participated in a summer day camp program. They were divided for 3 weeks into three behavior modification groups–no behavior modification, low-intensity behavior modification, and high-intensity behavior modification. In addition, the children were divided into four dosage groups for methylphenidate (placebo, 0.15 mg/kg, 0.3 mg/kg, and 0.6 mg/kg, three times daily).
Medication was randomized each day, and the program counselors recorded the children's behavior in areas such as failing to comply with staff requests, following activity rules, and exhibiting conduct problems.
When the data were reviewed at summer's end, the lowest dose of medication–0.15 mg/kg three times daily–had a surprising and substantial effect on reducing ADHD impairment. In fact, the maximum incremental value of medication to behavior modification occurred at this low dose.
“There was no incremental value for most children beyond the 0.15-mg/kg dose in combination with behavior modification, but the highest dose–0.6 mg/kg–produced the largest effects in the absence of behavior modification,” Dr. Pelham said. This dosage normalized the largest number of children when combined with behavior modification. The effects of behavior modification alone and medication alone were comparable.
“Medication alone does not normalize the children's performance,” he explained. “Even at the highest dose of 0.6 mg/kg three times daily, many children were not normalized; the effect of behavior modification is as strong as the effect of medication.” Lower doses produce a substantially lower level of side effects–a benefit of using behavior modification as the first-line intervention.
Parents also evaluated the treatment conditions; they ranked a high level of behavior modification therapy, either alone or in combination with medication, as their first choice for managing ADHD, compared with medication alone or with a lower level of behavior modification alone.
The investigators conducted a follow-up study to assess the effectiveness of sequencing medication and behavior modification in a school setting. The primary outcome measure was the maintenance of acceptable behavior without medication after summer exposure to both medication and behavioral therapy.
The study included 128 of the children from the summer program who were randomly assigned to one of three groups. A total of 44 children received high behavior modification treatment, 43 received low behavior modification treatment, and 41 received no behavior modification treatment.
Overall, nearly twice the number of children who received some level of behavior modification remained off medication at school during the fall semester, compared with children who received no behavior modification (60% vs. 30%).
In addition, about 80% of children who had received behavior modification remained off medication at home. A caveat, however, was that almost all the children (75%) had been taking medication before enrollment in the summer study, which influenced their ability to remain unmedicated, Dr. Pelham noted.
Children who received no behavior modification started taking medication during the school day after 13 weeks, compared with 19 weeks for the low-intensity behavioral therapy group and 20 weeks for the high-intensity behavioral therapy group. Similarly, children who received no behavior modification therapy started taking medication at home after 27 weeks, compared with 38 weeks for the low behavior modification group and 32 weeks for the high behavior modification group.
Future research will include younger, medication-naive children, recruited at age 5–6 years, he said. “If we could use a low level of behavior modification therapy in this group, we may be able to keep them off medication,” Dr. Pelham said.
Dr. Pelham has been a consultant, scientific adviser, speaker, and grant recipient for the following companies: McNeil Consumer Healthcare/ALZA (developers and marketers of the methylphenidate product known as Concerta), Abbott, Shire, Noven, Eli Lilly, and Cephalon.