Social-skills and parental training plus standard treatment versus standard treatment for children with ADHD--the randomised SOSTRA trial.

Abstract

ObjectiveTo investigate the effects of social-skills training and parental training programme for children with attention deficit hyperactivity disorder (ADHD).MethodsWe conducted a randomized two-armed, parallel group, assessor-blinded superiority trial consisting of social-skills training plus parental training and standard treatment versus standard treatment alone. A sample size calculation showed at least 52 children should be included for the trial with follow up three and six months after randomization. The primary outcome measure was ADHD symptoms and secondary outcomes were social skills and emotional competences. RESULTS 56: children (39 boys, 17 girls, mean age 10.4 years, SD 1.31) with ADHD were randomized, 28 to the experimental group and 27 to the control group. Mixed-model analyses with repeated measures showed that the time course (y = a + bt + ct(2)) of ADHD symptoms (p = 0.40), social skills (p = 0.80), and emotional competences (p = 0.14) were not significantly influenced by the intervention.ConclusionsSocial skills training plus parental training did not show any significant benefit for children with attention deficit hyperactivity disorder when compared with standard treatment. More and larger randomized trials are needed.Trial registrationClinicalTrials.gov NCT00937469.