Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
| Child and Adolescent Psychiatry, Stockholm | INDUSTRY |
| Stiftelsen Sunnerdahls Handikappfond | OTHER |
| Swedish Foundation for Strategic Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate if neurofeedback and working memory training improves core symptoms of ADHD in children and adolescents.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCP training | Active Comparator | Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training |
|
| Live Z-score training | Active Comparator | Neurofeedback 2 (NF2) Live Z-score training |
|
| WM training | Active Comparator | Working Memory training (WMt) |
|
| Waiting-list | No Intervention | Treatment as usual only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCP training | Behavioral |
| ||
| Live Z-score training |
| Measure | Description | Time Frame |
|---|---|---|
| Conners 3 ADHD-index | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sven Bölte, Professor | Karolinska Institute, Competence Center of Neurodevelopmental Disorders (KIND) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cap Bup-Kind | Stockholm | 11330 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 32497051 | Result | 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. | |
| 34478006 |
| Label | URL |
|---|---|
| Competence Center of Neurodevelopmental Disorders (KIND) | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SCP Training | Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training SCP training |
| FG001 | Live Z-score Training | Neurofeedback 2 (NF2) Live Z-score training (LZT) Live Z-score training |
| FG002 | WM Training | Working Memory training (WMt) WM training |
| FG003 | Waiting-list | Treatment as usual only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SCP Training | Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training SCP training |
| BG001 | Live Z-score Training | Neurofeedback 2 (NF2) Live Z-score training (LZT) Live Z-score training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Conners 3 ADHD-index | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to seven months |
|
Adverse Events were monitored using the Pediatric Side Effects Checklist (Pavuluri & Janicak, 2004) during the five-week training period. Additionally adverse events were assessed during the baseline-assessment (week 0), at the post-assessment (week 7) and at the follow-up assessment (6-month after post-assessment).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SCP Training | Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training SCP training |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Sven Bölte | KIND, KBH, Karolinska Institutet | 0046703170105 | sven.bolte@ki.se |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2013 | Aug 5, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| WM training | Behavioral |
|
| Result |
| 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. |
| 35034510 | Result | 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. |
| Webpage for BUP KIND - the KITE-project | View source |
| BG002 | WM Training | Working Memory training (WMt) WM training |
| BG003 | Waiting-list | Treatment as usual only |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Symptom Severity - Conners3 ADHD-index | Conners-3, ADHD-index, T-scores Scores range from 40-90 (swedish norms) Higher score indicate greater symptom severity. | Mean | Standard Deviation | units on a scale |
|
| Symptom Severity (Range) | Conners-3, adhd-index, T-scores Scores range from 40-90 (swedish norms) | Median | Full Range | units on a scale |
|
| OG002 |
| WM Training |
Working Memory training (WMt) WM training |
| OG003 | Waiting-list | Treatment as usual only |
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Live Z-score Training | Neurofeedback 2 (NF2) Live Z-score training Live Z-score training | 0 | 50 | 0 | 50 | 0 | 50 |
| EG002 | WM Training | Working Memory training (WMt) WM training | 0 | 51 | 0 | 51 | 0 | 51 |
| EG003 | Waiting-list | Treatment as usual only | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
Not provided
| Male |
|
|
|
|
|