Neurofeedback Intervention on the Development of ADHD in Children at Risk
Condition: ADHD
Study type: Interventional

Summary: 
      Forty children considered at risk for ADHD (subclinical ADHD) will be randomized to either a
      neurofeedback intervention or waiting list.
    

Detailed description: 
      Attention Deficit Hyperactive Disorder (ADHD) is one of the most common mental disorders
      among children. It is associated with an important burden to individuals, their families and
      society. ADHD is a chronic condition and the majority of affected individuals presents
      symptoms and associated functional deficit through adult life. Although pharmacological
      treatment can be easily implemented and are short-term effective, its efficacy tends to
      decrease with time and long-term effects are uncertain. Psychosocial treatments tend to be
      effective only during treatment delivery and treatment effects are not sustained. New
      treatment strategies are required in order to provide better care to ADHD patients. Early
      interventions might avoid the development of the disorder, limit its persistency or prevent
      associated deficits. The aim of this study is to evaluate the efficacy of a
      non-pharmacological intervention for children at risk for ADHD.

      This randomized controlled clinical trial has the aim of testing the efficacy of
      neurofeedback for children at increased risk for ADHD (subclinical ADHD symptoms). This is
      study is a multisite school based trial. Forty children from the 1st to the 4th grade with
      subclinical ADHD symptoms will be randomized to neurofeedback or waiting list. Subclinical
      ADHD will be defined as having 3-5 out of 9 inattention and/or hyperactivity/impulsivity
      symptoms according to parents clinical evaluation (K-SADS-PL) but less than 6 symptoms
      according to teachers report (assessed using SNAP-IV) OR 3-5 symptoms according to teachers
      report and less than 6 according to parents clinical evaluation. Exclusion criteria includes
      IQ lower than 80, severe mental disorder or neurological disease. Treatment will comprise 25
      sessions of NF using Slow Cortical Potential training. Children will be invited to attend 2
      sessions per week, each session comprises 4 blocs of 20 trials with both activation and
      deactivation challenges. Eldith Tharaprax equipment will be used in both sites. The study,
      including treatment sessions, will be conducted in schools. Two public schools were selected
      to host the study, one in São Paulo and another in Porto Alegre, Brazil. Main outcome will be
      parents rating scores for ADHD symptoms (SWAN questionnaire). To avoid bias due to the low
      literacy of our population, parents will be assisted by a staff member to fill the SWANs
      questionnaires. Second outcomes includes: 1) Performance on computerized tests designed to
      measures time processing, basic processing, inhibitory control and executive function and
      delay aversion and 2) Pre- post treatment differences on electrophysiological measures (evoke
      related potentials during two tasks that requires sustained attention, self-monitoring and
      response to attentional prime); 3) conversion to ADHD (incident cases). Outcomes measures
      will be assessed prior to treatment start, in after the 13 session, soon after the 25
      session, after 6 months of follow-up. Random regression will be used to model each subject's
      response against time (from baseline to session 12 and from 12th session to treatment end).
      For continuous variables we will compare the average slope of the regression line across the
      two groups to test whether the intervention is superior to waiting-list. Proportion of new
      cases will be compared across groups using chi square test.
    

Intervention name(s): Neurofeedback
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention