Neurofeedback Study ADHD
1 other identifier
interventional
120
1 country
1
Brief Summary
Neurofeedback has proved to be effective in treating Attention deficit hyperactivity disorder (ADHD) in experimental settings. This study investigates whether neurofeedback can be used as a therapeutic intervention in regular outpatient care. The investigators compare high frequent neurofeedback with high frequent self-management therapy and suppose that both result in comparable effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2011
Longer than P75 for phase_2
1 active site
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
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 28, 2013
CompletedFirst Posted
Study publicly available on registry
June 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 15, 2016
November 1, 2016
7 years
May 28, 2013
November 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)
Children perform the Qb-Test: * T1 baseline diagnostic before therapy, 1 week * T2 post assessment after 36 therapy sessions, expected average of 12 weeks * T3 catamnestic measurement 6 months after T2 * T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 months
Conners Psychopathology Scores
Conners parents \& teacher rating scales: * T1 baseline diagnostic before therapy, 1 week * T2 post assessment after 36 therapy sessions, expected average of 12 weeks * T3 catamnestic measurement 6 months after T2 * T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months
Secondary Outcomes (6)
Social Support
Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months
Self-Concept
Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months
Perceived Criticism
Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months
Parental Stress (ESF)
Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months
Cortisol
Pre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 month
- +1 more secondary outcomes
Study Arms (4)
Neurofeedback with Psychoeducation (NF + PE)
ACTIVE COMPARATORNeurofeedback plus Parental Psychoeducation
Self-Management with Psychoeducation (SM + PE)
ACTIVE COMPARATORSelf-management + parental psychoeducation
NF+PE and additional Social Support (SU)
ACTIVE COMPARATORNeurofeedback + parental psychoeducation enhanced with social support
SM+PE and additional Social Support (SU)
ACTIVE COMPARATORSelf-management + parental psychoeducation enhanced with social support
Interventions
Eligibility Criteria
You may qualify if:
- children with ADHD aged 7 to 11
- full command of the German language.
You may not qualify if:
- IQ below 80
- Children with symptoms of:
- inattention,
- hyperactivity or
- impulsivity due to other medical reasons such as:
- hyperthyreosis,
- autism,
- epilepsy,
- brain disorders and
- any genetic or medical disorder associated with externalizing behavior that mimics ADHD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Philipps-University Marburg, Department of Psychology, Clinical Child and Adolescent Psychology
Marburg, Hesse, 35037, Germany
Related Publications (2)
Christiansen H, Reh V, Schmidt MH, Rief W. Slow cortical potential neurofeedback and self-management training in outpatient care for children with ADHD: study protocol and first preliminary results of a randomized controlled trial. Front Hum Neurosci. 2014 Nov 26;8:943. doi: 10.3389/fnhum.2014.00943. eCollection 2014.
PMID: 25505396RESULTKorfmacher AK, Hirsch O, Chavanon ML, Albrecht B, Christiansen H. Self-management training vs. neurofeedback interventions for attention deficit hyperactivity disorder: Results of a randomized controlled treatment study. Front Psychiatry. 2022 Aug 18;13:969351. doi: 10.3389/fpsyt.2022.969351. eCollection 2022.
PMID: 36061275DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
May 28, 2013
First Posted
June 18, 2013
Study Start
January 1, 2011
Primary Completion
January 1, 2018
Study Completion
December 1, 2018
Last Updated
November 15, 2016
Record last verified: 2016-11