blinding
Research Papers
EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial
Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) ADHD were randomized to active NF versus sham-NF and to 2X versus 3X/week treatment frequency. Frequency switch was allowed after Treatment 24. Results: In two school years, 39 participants were recruited and 34 (87%) completed all 40 treatments. Child/parent guesses about assigned treatment were no better than chance. At Treatment 24, 38% chose 2X/week and 62% chose 3X/week. Both active NF and sham yielded large pre–post improvement on parent ratings but NF no more than sham. Conclusion: Blinding appears to work, and sham does not prevent recruitment/retention. Treatment frequency of 3X/week seems preferred over 2X/week and was as effective. A large double-blind RCT is feasible and necessary to test specific NF effectiveness.
View Full Paper →A Review of Neurofeedback Treatment for Pediatric ADHD
Objective: The aim of this paper was to review all randomized published trials and unpublished conference presentations on the neurofeedback (NF) treatment of pediatric ADHD, and their relevance, strengths, and limitations. Method: Via PsychInfo and Medline searches and contacts with NF researchers 14 studies were identified and reviewed. Results: The majority were conducted from 1994 to 2010, with 5- to 15-year-olds, usually male and White with the combined type of ADHD. Most studies used theta/beta NF with a unipolar-electrode placement at Cz and demonstrated, where reported, an overall ADHD mean effect size of d = 0.69, a medium effect. Main study strengths, within some studies, include use of randomization, treatment control conditions, Diagnostic and Statistical Manual of Mental Disorders criteria, evidence-based assessment of ADHD, standard treatment outcome measures, multidomain assessment, and, for some studies, moderate sample size, some type of blind and the identification of medication as a concomitant treatment. Main study limitations (and directions for future research) include the lack of adequate blinding of participants, raters and NF trainers, a sham-NF/blinded control treatment condition, posttreatment follow-up, generalizability, specific details about delivery of NF, identification and control of comorbidity, and the identification, measurement, and control of concomitant treatments and potential side effects. Conclusion: Based on the results and methodologies of published studies, this review concludes that NF for pediatric ADHD can be currently considered as “probably efficacious.”
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