Cluster-randomized, controlled 12-month trial to evaluate the effect of a parental psychoeducation program on medication persistence in children with attention-deficit/hyperactivity disorder

Abstract

Alonso Montoya,1 Amaia Hervás,2 Joaquín Fuentes,3 Esther Cardo,4 Pepa Polavieja,5 Javier Quintero,6 Rosemary Tannock7 1Medical Neurosciences, Lilly Research Laboratories Canada, Toronto, ON, Canada; 2Child and Adolescent Mental Health Unit, Hospital Universitari Mutua de Terrassa, and Developmental Disorders Unit, Hospital Sant Joan de Déu, Barcelona, 3Child and Adolescent Psychiatry Unit, Policlinica Gipuzkoa, San Sebastian, 4Neuropediatric Unit, Hospital Son Llatzer, University of the Balearic Islands, Palma de Mallorca, 5Department of Clinical Research, Lilly Research Laboratories Spain, Alcobendas, 6Department of Psychiatry, Hospital Universitario Infanta Leonor, Madrid, Spain; 7Applied Psychology and Human Development, and Neurosciences and Mental Health Research Program, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada Background: This multicenter, cluster-randomized, nonblinded study evaluated the effect of parental psychoeducation on medication persistence among children and adolescents with newly diagnosed attention-deficit/hyperactivity disorder (ADHD). Methods: Patients received standard medication alone or medication plus a parental psychoeducation program, and were followed for 12 months. The primary endpoint was time to withdrawal or termination of medication due to any cause. Secondary endpoints included change in ADHD symptom severity, functional outcome, program satisfaction, and safety. Results: A total of 208 patients completed the study, which was terminated early because recruitment had ceased. At 12 months, there was no significant difference between the psychoeducation and control groups in the proportion of patients who discontinued pharmacologic treatment (13.2% versus 14.3%, respectively; size effect -0.3, P=0.34; hazard ratio 0.72, 95% confidence interval 0.36–1.43). Psychoeducation was associated with a significantly greater improvement in ADHD symptoms but not in functional outcome. Parental satisfaction with psychoeducation was high, and satisfaction with pharmacologic treatment was significantly greater in the psychoeducation group. There were no safety concerns. Conclusion: No significant advantage for parental psychoeducation plus medication over medication alone in terms of time to medication withdrawal was observed. Psychoeducation had inconsistent but interesting effects on other outcomes. Keywords: psychoeducation, medication persistence, attention-deficit/hyperactivity disorder, adjunctive psychoeducation, parents