Efficacy of multiple-component cognitive training for ADHD children: a randomized controlled trial with subgroup analysis

Computerized cognitive training is a promising non-pharmacological intervention for attention-deficit/hyperactivity disorder (ADHD). This study aimed to assess the efficacy of IBT-AC01, a multicomponent cognitive training program, in improving cognitive function and clinical symptoms in children with ADHD and to explore potential treatment-responsive subgroups. In a double-blind, parallel-group randomized clinical trial, 105 participants (6–12 years) with ADHD were randomly assigned 1:1 to IBT-AC01 or a control group. Participants received daily 25-minute training sessions, five days a week for four weeks. Primary outcomes, The Attention Comparison Score (ACS) on the Test of Variables of Attention (TOVA), and the summary score of the ADHD Rating Scale-IV (ADHD-RS-IV), were assessed using regression models adjusted for baseline scores, age and sex. Exploratory subgroup analyses were conducted using model-based recursive partitioning. In the primary intention-to-treat analysis, no significant between-group treatment effects were observed. For TOVA ACS, the adjusted between-group difference was β = 0.33 (95% CI: -0.54 to 1.20, p = 0.45). For ADHD-RS-IV total score, the adjusted between-group difference was β = -1.07 (95% CI: -3.73 to 1.59, p = 0.43). Exploratory subgroup analyses suggested that younger participants, children with comorbid oppositional defiant disorder (ODD), and those with higher baseline ADHD symptom severity may derive greater benefit from IBT-AC01. IBT-AC01 did not demonstrate significant benefits in the overall sample of children with ADHD. Exploratory findings suggest treatment response may vary according to developmental and clinical characteristics. Future studies with larger samples are needed to confirm efficacy and explore underlying mechanisms. Full name of the registry: Chinese Clinical Trial Registry. Trial registration number: ChiCTR2200057306. Date of registration: 2022/03/07