- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01841151
Neurofeedback and Working Memory Training for Children and Adolescents With ADHD (KITE)
Does Neurofeedback and Working Memory Training Improve Core Symptoms of ADHD in Children and Adolescents? A Comparative, Randomized and Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study investigates two types of Neurofeedback (NF), one well-established and well-researched protocol called Slow Cortical Potential NF (SCP), and a newer and less researched, yet popular among private clinicians, the so-called live z-score training (LZT). These methods are compared to working memory training (WMT) and a passive control condition, treatment-as-usual only (TAU). The active conditions (SCP/LZT/WMT) are delivered high frequent, with 5 sessions/week, for a total of 25 sessions.
Outcomes measures are taken at Preintervention and Postintervention, as well as at a 6-month follow-up assessment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Stockholm, Sweden, 11330
- Cap Bup-Kind
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical AD/HD diagnose according to DSM-IV-TR and K-SADS interview, 9-17 years old, unmedicated or under stable medication with stimulants or corresponding since at least one month.
Exclusion Criteria:
- IQ <70 (WISC-IV or WAIS-IV), clinically instable psychiatric state e.g. severe depression, OCD, self-injurious behaviour, bipolar disorder, severe somatic (neurologic) disease, very limited knowledge in the Swedish language.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SCP training
Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training
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|
|
Active Comparator: Live Z-score training
Neurofeedback 2 (NF2) Live Z-score training
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|
|
Active Comparator: WM training
Working Memory training (WMt)
|
|
|
No Intervention: Waiting-list
Treatment as usual only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conners 3 ADHD-index
Time Frame: Up to seven months
|
Presented below are the within-group differences from baseline to 6-month follow up, for the ADHD-index of the Conners-3. Positive numbers indicate symptom improvements. *The ADHD-index raw score can range from 0-20, with higher score indicating greater symptom severity. The Reliable Change Index (RCI) is 2.88. |
Up to seven months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sven Bölte, Professor, Karolinska Institute, Competence Center of Neurodevelopmental Disorders (KIND)
Publications and helpful links
General Publications
- Hasslinger, J., Sirviö, S., Berggren, S., Myers, L., Flygare, O., Tammimies, K., & Bölte, S. (2016). A comparative randomized controlled pragmatic trial of neurofeedback and working memory training for children with attention-deficit/hyperactivity disorder: protocol. Translational Developmental Psychiatry, 4(1). https://doi.org/10.3402/tdp.v4.30556
- Hasslinger J, D'Agostini Souto M, Folkesson Hellstadius L, Bolte S. Neurofeedback in ADHD: A qualitative study of strategy use in slow cortical potential training. PLoS One. 2020 Jun 4;15(6):e0233343. doi: 10.1371/journal.pone.0233343. eCollection 2020.
- Hasslinger J, Bolte S, Jonsson U. Slow Cortical Potential Versus Live Z-score Neurofeedback in Children and Adolescents with ADHD: A Multi-arm Pragmatic Randomized Controlled Trial with Active and Passive Comparators. Res Child Adolesc Psychopathol. 2022 Apr;50(4):447-462. doi: 10.1007/s10802-021-00858-1. Epub 2021 Sep 3.
- Hasslinger J, Jonsson U, Bolte S. Immediate and Sustained Effects of Neurofeedback and Working Memory Training on Cognitive Functions in Children and Adolescents with ADHD: A Multi-Arm Pragmatic Randomized Controlled Trial. J Atten Disord. 2022 Sep;26(11):1492-1506. doi: 10.1177/10870547211063645. Epub 2022 Jan 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KITE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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