Abstract
BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder often managed with medication. Improving cognitive functions alongside medication treatment is crucial for better outcomes. This study mainly aimed to investigate the therapeutic effects of combining digitally targeted cognitive training with medication compared to medication monotherapy on ADHD core symptoms. We hypothesized that targeted cognitive training could enhance treatment efficacy when combined with medication. METHODS: This was a randomized parallel-group controlled trial. A total of 124 children with ADHD were randomly allocated to two groups: 64 received medication treatment alone (M), including atomoxetine (ATX) and methylphenidate (MPH); 60 received targeted cognitive training combined with medication (TCT + M), including TCT + ATX and TCT + MPH. Both groups received 8 weeks of treatment. The primary outcome was the changes in ADHD core symptoms measured by the ADHD Rating Scale (ADHD-RS). The secondary outcomes were parent-reported ecological executive functions, social functions, and laboratory cognitive functions. RESULTS: Main results: When compared with M treatment, the TCT + M treatment did not show significant greater improvements in ADHD core symptoms, ecological executive functions, social functions, or laboratory cognitive functions. Post-hoc exploratory analysis results: (1) In patients who received ATX treatment, TCT + ATX led to greater improvement in ADHD-RS total, inattention, and hyperactivity/impulsivity symptoms. Similar between-group differences were observed in ecological executive functions, and the improvements were significantly correlated with changes of ADHD core symptoms. (2) In patients who received MPH treatment, no significant differences in the improvement of primary or secondary outcomes were observed between MPH monotherapy and TCT + MPH groups. CONCLUSIONS: These findings demonstrated that, in comparison to medication monotherapy, the TCT + M treatment did not lead to more improvements in the core symptoms of ADHD, nor did it show superiority in other secondary outcomes. Specifically in children treated with atomoxetine, there's a potential promoting effect of targeted cognitive training on medication treatment in terms of the alleviation of ADHD core symptoms. TRIAL REGISTRATION: This study was pre-registered with the Chinese Clinical Trial Registry under the identifier ChiCTR2100043525.