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Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is an impairing condition that widely affects a child's life. Current treatment guidelines for preschool-aged children suggest prescribing evidence-based parent or teacher-administered behavior therapy (BT) as the first line of treatment. Psychostimulants can be prescribed for non-respondents and moderate-to-severe cases, but they have side effects. Alternative therapy is neurofeedback, which has already shown effectiveness in the older children population but not in preschoolers. Objective: To evaluate if neurofeedback associated with behavioral therapy is superior in efficacy compared to sham neurofeedback plus behavioral therapy for treating newly diagnosed ADHD in preschoolers.
Methods: This will be a multicenter, randomized, single-blinded, parallel-group, superiority phase III study including 274 patients in five sites. Participants are children aged 4 to 6 years old with a confirmed diagnosis of moderate-severe ADHD by a treating physician. Both groups will receive 48 neurofeedback or sham sessions in 24 weeks plus BT, with 6-month follow-up up to 36 months. The primary outcome is the improvement of ADHD symptoms measured by the ADHD Rating Scale-IV (ADHD-RS-IV). After six months, participants will be allowed to use medication if needed. Therefore, one of our secondary endpoints will be time-to-medication. Two hundred seventy-four participants will be enrolled.
Discussion: The NeFAP study is an innovative study of NF to treat symptoms of ADHD in preschoolers. If positive results are obtained, it may change the treatment landscape for preschoolers who typically have difficulty adhering to drug-based treatments.