A dose-ranging study of behavioral and pharmacological treatment in social settings for children with ADHD

Abstract

Placebo and three doses of methylphenidate (MPH) were crossed with 3 levels of behavioral modification (no behavioral modification, NBM; low-intensity behavioral modification, LBM; and high-intensity behavior modification, HBM) in the context of a summer treatment program (STP). Participants were 48 children with ADHD, aged 5-12. Behavior was examined in a variety of social settings (sports activities, art class, lunch) that are typical of elementary school, neighborhood, and after-school settings. Children received each behavioral condition for 3 weeks, order counterbalanced across groups. Children concurrently received in random order placebo, 0.15 mg/kg/dose, 0.3 mg/kg/dose, or 0.6 mg/kg/dose MPH, 3 times daily with dose manipulated on a daily basis in random order for each child. Both behavioral and medication treatments produced highly significant and positive effects on children's behavior. The treatment modalities also interacted significantly. Whereas there was a linear dose-response curve for medication in NBM, the dose-response curves flattened considerably in LBM and HBM. Behavior modification produced effects as large as moderate doses, and on some measures, high doses of medication. These results replicate and extend to social-recreational settings previously reported results in a classroom setting from the same sample (Fabiano et al., School Psychology Review, 36, 195-216, 2007). Results illustrate the importance of taking dosage/intensity into account when evaluating combined treatments; there were no benefits of combined treatments when the dosage of either treatment was high but combination of the low-dose treatments produced substantial incremental improvement over unimodal treatment.

Figure 1

Study design. Each child experienced three weeks of each behavioral condition, in counterbalanced order. Within each week, each child received 4 different doses of medication with order randomized such that each condition occurred at least once during each week.

Figure 2

Daily rates of noncompliance as a function of medication dose and behavior modification intensity.

Figure 3

Mean (+SD) standard effect sizes for each treatment compared with no-treatment (no behavior modification/placebo) on activity rule violations. ES were significantly different in pairwise tests with the exception of those connected by arrows.

Figure 4

Mean (+SD) effect sizes for each combined treatment compared with baseline of the other modality (e.g., behavior modification + medication compared with behavior modification alone) on activity rule violations.

Figure 5

Proportion of sample experiencing low, moderate or high effects sizes by treatment condition on activity rule violations.