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Personalized at‐home neurofeedback compared to long‐acting methylphenidate in children with ADHD: NEWROFEED, a European randomized noninferiority trial.
- Source :
- Journal of Child Psychology; Feb2022, Vol. 63 Issue 2, p187-198, 12p, 1 Diagram, 3 Charts
- Publication Year :
- 2022
-
Abstract
- Background: Neurofeedback is considered a promising intervention for the treatment of attention‐deficit hyperactivity disorder (ADHD). NEWROFEED is a prospective, multicentre, randomized (3:2), reference drug‐controlled trial in children with ADHD aged between 7 and 13 years. The main objective of NEWROFEED was to demonstrate the noninferiority of personalized at‐home neurofeedback (NF) training versus methylphenidate in the treatment of children with ADHD. Methods: The NF group (n = 111) underwent eight visits and two treatment phases of 16 to 20 at‐home sessions with down‐training of the theta/beta ratio (TBR) for children with high TBR and enhancing the sensorimotor rhythm (SMR) for the others. The control group (n = 67) received optimally titrated long‐acting methylphenidate. The primary endpoint was the change between baseline and endpoint in the Clinician ADHD‐RS‐IV total score in the per‐protocol population (90 NF/59 controls). Trial registration: US National Institute of Health, ClinicalTrials.gov #NCT02778360. Results: Our study failed to demonstrate noninferiority of NF versus methylphenidate (mean between‐group difference 8.09 90% CI [8.09; 10.56]). However, both treatment groups showed significant pre–post improvements in core ADHD symptoms and in a broader range of problems. Reduction in the Clinician ADHD‐RS‐IV total score between baseline and final visit (D90) was 26.7% (SMD = 0.89) in the NF and 46.9% (SMD = 2.03) in the control group. NF effects increased whereas those of methylphenidate were stable between intermediate and final visit. Conclusions: Based on clinicians' reports, the effects of at‐home NF were inferior to those of methylphenidate as a stand‐alone treatment. [ABSTRACT FROM AUTHOR]
- Subjects :
- TREATMENT of attention-deficit hyperactivity disorder
RESEARCH
METHYLPHENIDATE
CONFIDENCE intervals
HOME care services
INDIVIDUALIZED medicine
ATTENTION-deficit hyperactivity disorder
PHYSIOLOGICAL control systems
TREATMENT effectiveness
RANDOMIZED controlled trials
COMPARATIVE studies
PRE-tests & post-tests
DESCRIPTIVE statistics
STATISTICAL sampling
CONTROL groups
LONGITUDINAL method
EVALUATION
SYMPTOMS
CHILDREN
Subjects
Details
- Language :
- English
- ISSN :
- 00219630
- Volume :
- 63
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- Journal of Child Psychology
- Publication Type :
- Academic Journal
- Accession number :
- 155253977
- Full Text :
- https://doi.org/10.1111/jcpp.13462