A 14-Month Randomized Clinical Trial of Treatment Strategies for Attention-Deficit/Hyperactivity Disorder

TLDR

Previous research shows short‑term benefits of pharmacotherapy and behavior therapy for ADHD, but long‑term (>4 months) comparative studies are lacking. In a 14‑month randomized trial of 579 children with ADHD combined type, participants were assigned to medication management, intensive behavioral treatment, a combined approach, or standard community care, with outcomes measured repeatedly and analyzed by intent‑to‑treat random‑effects regression. All groups showed large symptom reductions, but medication management and the combined treatment outperformed intensive behavioral therapy and community care, with the combined approach offering additional benefits for oppositional, internalizing, social‑skills, parent‑child relations, and reading outcomes, though it did not significantly exceed medication alone for core ADHD symptoms.

Abstract

<h3>Background</h3> Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder (ADHD), but no longer-term (ie, &gt;4 months) investigations have compared these 2 treatments or their combination. <h3>Methods</h3> A group of 579 children with ADHD Combined Type, aged 7 to 9.9 years, were assigned to 14 months of medication management (titration followed by monthly visits); intensive behavioral treatment (parent, school, and child components, with therapist involvement gradually reduced over time); the two combined; or standard community care (treatments by community providers). Outcomes were assessed in multiple domains before and during treatment and at treatment end point (with the combined treatment and medication management groups continuing medication at all assessment points). Data were analyzed through intent-to-treat random-effects regression procedures. <h3>Results</h3> All 4 groups showed sizable reductions in symptoms over time, with significant differences among them in degrees of change. For most ADHD symptoms, children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care. Combined and medication management treatments did not differ significantly on any direct comparisons, but in several instances (oppositional/aggressive symptoms, internalizing symptoms, teacher-rated social skills, parent-child relations, and reading achievement) combined treatment proved superior to intensive behavioral treatment and/or community care while medication management did not. Study medication strategies were superior to community care treatments, despite the fact that two thirds of community-treated subjects received medication during the study period. <h3>Conclusions</h3> For ADHD symptoms, our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication. Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms, but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes.