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The problem
Intervention: Adjunctive risperidone medication added to ongoing structured behavioral intervention and parental psychoeducation
Who it was tested with: Children aged 3-12 years with moderate-to-severe ADHD and significant behavioral dysregulation refractory to behavioral intervention alone (n=94 total: 48 risperidone, 46 placebo).
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"In this 48-week randomized, placebo-controlled, assessor-blinded trial, children aged 3-12 years with moderate-to-severe ADHD and significant behavioral dysregulation refractory to behavioral intervention alone were allocated to risperidone (n = 48) or matched placebo (n = 46), both in addition to ongoing structured behavioral intervention and parental psychoeducation." The study used random allocation with a comparison group and blinded assessment of outcomes, meeting criteria for experimental evidence tier.
Study limited to carefully selected children with prominent behavioral dysregulation; results may not generalize to children with uncomplicated ADHD. Metabolic and endocrine adverse effects require ongoing monitoring. Country of conduct not specified.
Across countries and designs
1 study · 0 countries