NCT01841151

Brief Summary

The purpose of this study is to investigate if neurofeedback and working memory training improves core symptoms of ADHD in children and adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

6.3 years

First QC Date

April 20, 2013

Results QC Date

May 20, 2022

Last Update Submit

August 6, 2025

Conditions

Attention Deficit Disorder

Keywords

AD/HD in Children and Adolescents

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

SCP training

ACTIVE COMPARATOR

Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training

Behavioral: SCP training

Live Z-score training

ACTIVE COMPARATOR

Neurofeedback 2 (NF2) Live Z-score training

Behavioral: Live Z-score training

WM training

ACTIVE COMPARATOR

Working Memory training (WMt)

Behavioral: WM training

Waiting-list

NO INTERVENTION

Treatment as usual only

Interventions

SCP trainingBEHAVIORAL
SCP training
Live Z-score trainingBEHAVIORAL
Live Z-score training
WM trainingBEHAVIORAL
WM training

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cap Bup-Kind

Stockholm, 11330, Sweden

Location

Related Publications (4)

  • 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

    BACKGROUND

  • 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.

    PMID: 32497051RESULT

  • 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.

    PMID: 34478006RESULT

  • 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.

    PMID: 35034510RESULT

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Prof. Sven Bölte
Organization
KIND, KBH, Karolinska Institutet
sven.bolte@ki.se
0046703170105

Study Officials

  • Sven Bölte, Professor

    Karolinska Institute, Competence Center of Neurodevelopmental Disorders (KIND)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, head of pediatric neuropsychiatry unit

Study Record Dates

First Submitted

April 20, 2013

First Posted

April 26, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2019

Study Completion

October 1, 2020

Last Updated

August 7, 2025

Results First Posted

August 7, 2025

Record last verified: 2025-08

Locations

SE(1)