Emotional problems and dysregulation in children/youth with <scp>ADHD</scp> : predictive and moderating effects in a randomized controlled trial of methylphenidate and neurofeedback

Background Children and adolescents with Attention‐Deficit/Hyperactivity Disorder (ADHD) often show increased emotional dysregulation (ED) and internalizing emotional problems (iEP). However, the predictive and moderating role of these emotional difficulties in the treatment of ADHD—particularly regarding pharmacological (methylphenidate, MPH) and non‐pharmacological approaches (neurofeedback at home, NF@home)—remains understudied. This study aims to evaluate the effectiveness of MPH and NF@home in reducing iEP/ED in children with ADHD and to assess the predictive role of iEP/ED and neuropsychological executive function (EF) measures in treatment outcomes. Methods The per‐protocol sample included 146 children (7–13 years) diagnosed with ADHD (inattentive or combined type). iEP was measured with the Strengths and Difficulties Questionnaire (SDQ), ED via a dysregulation profile, and EF using the BRIEF and Continuous Performance Test (CPT). ADHD symptoms were assessed using the ADHD Rating Scale IV. Participants were randomized to either the MPH group ( n = 59) or the NF group ( n = 87), which included NF SMR ( n = 72) and NF TBR ( n = 15), based on individual Theta/Beta‐Ratio (TBR). Mixed‐model analyses considered symptom severity at baseline, age, gender, IQ, and study center as covariates. Results All intervention groups showed significant changes in iEP, but with different effects regarding parent (NF SMR : d = −0.396, 95% CI [−0.574, −0.217]; NF TBR : d = −0.367, 95% CI [−0.747, 0.013]; MPH: d = −0.409, 95% CI [−0.603, −0.215]) and teacher ratings (NF SMR : d = −0.211, 95% CI [−0.405, −0.017]; NF TBR : d = −0.639, 95% CI [−1.06, −0.222]; MPH: d = −0.142, 95% CI [−0.340, 0.056]). There was no between‐intervention effect, supported by non‐inferiority analyses. For ED, we also found significant effects for all interventions; however, significantly more pronounced effects were obtained for MPH. Moreover, both prediction models indicated a limited predictive value. Conclusions The findings suggest non‐inferiority of NF versus MPH treating iEP within an ADHD sample. However, due to limited predictive value, no clear clinical guidance can yet be drawn regarding personalized treatment recommendations. Further studies are needed to confirm and extend these findings.