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

This study is currently recruiting participants.
Verified August 2017 by Sven Bölte, Karolinska Institutet
Sponsor:
ClinicalTrials.gov Identifier:
NCT01841151
First Posted: April 26, 2013
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  Purpose
The purpose of this study is to investigate if neurofeedback and working memory training improves core symptoms of ADHD in children and adolescents.

Condition Intervention
Attention Deficit Disorder Behavioral: SCP training Behavioral: Live Z-score training Behavioral: WM training

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Sven Bölte, Karolinska Institutet:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 220
Study Start Date: August 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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)
  More Information

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 Submitted: April 20, 2013
First Posted: April 26, 2013
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