Neurofeedback and Working Memory Training for Children and Adolescents With ADHD (KITE)
Primary Purpose
Attention Deficit Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
SCP training
Live Z-score training
WM training
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder focused on measuring AD/HD in Children and Adolescents
Eligibility 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.
Sites / Locations
- Cap Bup-Kind
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
SCP training
Live Z-score training
WM training
Waiting-list
Arm Description
Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training
Neurofeedback 2 (NF2) Live Z-score training
Working Memory training (WMt)
Treatment as usual only
Outcomes
Primary Outcome Measures
The Conners 3
Self-, parents- and teachers report. Outcome measures will be conducted before and after five weeks training, and at 6 months follow-up.
Secondary Outcome Measures
Full Information
NCT ID
NCT01841151
First Posted
April 20, 2013
Last Updated
August 31, 2021
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Child and Adolescent Psychiatry, Stockholm, Stiftelsen Sunnerdahls Handikappfond, Swedish Foundation for Strategic Research
1. Study Identification
Unique Protocol Identification Number
NCT01841151
Brief Title
Neurofeedback and Working Memory Training for Children and Adolescents With ADHD
Acronym
KITE
Official Title
Does Neurofeedback and Working Memory Training Improve Core Symptoms of ADHD in Children and Adolescents? A Comparative, Randomized and Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Child and Adolescent Psychiatry, Stockholm, Stiftelsen Sunnerdahls Handikappfond, Swedish Foundation for Strategic Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder
Keywords
AD/HD in Children and Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCP training
Arm Type
Active Comparator
Arm Description
Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training
Arm Title
Live Z-score training
Arm Type
Active Comparator
Arm Description
Neurofeedback 2 (NF2) Live Z-score training
Arm Title
WM training
Arm Type
Active Comparator
Arm Description
Working Memory training (WMt)
Arm Title
Waiting-list
Arm Type
No Intervention
Arm Description
Treatment as usual only
Intervention Type
Behavioral
Intervention Name(s)
SCP training
Intervention Type
Behavioral
Intervention Name(s)
Live Z-score training
Intervention Type
Behavioral
Intervention Name(s)
WM training
Primary Outcome Measure Information:
Title
The Conners 3
Description
Self-, parents- and teachers report. Outcome measures will be conducted before and after five weeks training, and at 6 months follow-up.
Time Frame
Up to seven months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Bölte, Professor
Organizational Affiliation
Karolinska Institute, Competence Center of Neurodevelopmental Disorders (KIND)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cap Bup-Kind
City
Stockholm
ZIP/Postal Code
11330
Country
Sweden
12. IPD Sharing Statement
Links:
URL
https://ki.se/kind/center-of-neurodevelopmental-disorders-at-karolinska-institutet-kind
Description
Competence Center of Neurodevelopmental Disorders (KIND)
URL
http://ki.se/en/kind/kite-neurofeedback-and-working-memory-training
Description
Webpage for BUP KIND - the KITE-project
Learn more about this trial
Neurofeedback and Working Memory Training for Children and Adolescents With ADHD
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