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Neurofeedback and Working Memory Training for Children and Adolescents With ADHD (KITE)

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ClinicalTrials.gov Identifier: NCT01841151
Recruitment Status : Recruiting
First Posted : April 26, 2013
Last Update Posted : August 22, 2017
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Child and Adolescent Psychiatry, Stockholm
Stiftelsen Sunnerdahls Handikappfond
Swedish Foundation for Strategic Research
Information provided by (Responsible Party):
Sven Bölte, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder Behavioral: SCP training Behavioral: Live Z-score training Behavioral: WM training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Neurofeedback and Working Memory Training Improve Core Symptoms of ADHD in Children and Adolescents? A Comparative, Randomized and Controlled Study.
Study Start Date : August 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: SCP training
Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training
Behavioral: SCP training
Active Comparator: Live Z-score training
Neurofeedback 2 (NF2) Live Z-score training
Behavioral: Live Z-score training
Active Comparator: WM training
Working Memory training (WMt)
Behavioral: WM training
No Intervention: Waiting-list



Primary Outcome Measures :
  1. The Conners 3 [ Time Frame: Up to seven months ]
    Self-, parents- and teachers report. Outcome measures will be conducted before and after five weeks training, and at 6 months follow-up.



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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841151


Contacts
Contact: Sven Bölte, PhD 0046703170105 sven.bolte@ki.se
Contact: John Hasslinger, MSc 0046704849632 john.hasslinger@sll.se

Locations
Sweden
Cap Bup-Kind Recruiting
Stockholm, Sweden, 11330
Contact: John Hasslinger, MSc    0046704849632    john.hasslinger@sll.se   
Principal Investigator: Sven Bölte, PhD         
Sub-Investigator: John Hasslinger, MSc         
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Child and Adolescent Psychiatry, Stockholm
Stiftelsen Sunnerdahls Handikappfond
Swedish Foundation for Strategic Research
Investigators
Principal Investigator: Sven Bölte, Professor Karolinska Institute, Competence Center of Neurodevelopmental Disorders (KIND)

Additional Information:
Responsible Party: Sven Bölte, Professor, PhD, head of pediatric neuropsychiatry unit, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01841151     History of Changes
Other Study ID Numbers: KITE
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Sven Bölte, Karolinska Institutet:
AD/HD in Children and Adolescents

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders