Skip to content

Neurofeedback Study ADHD

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01879644
Enrollment
120
Registered
2013-06-18
Start date
2011-01-31
Completion date
2018-12-31
Last updated
2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, Neurofeedback, Self-Management, Parental Psychoeducation, Social Support

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.

Interventions

BEHAVIORALNF
BEHAVIORALSM
BEHAVIORALPE
BEHAVIORALSU

Sponsors

Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

* children with ADHD aged 7 to 11 * full command of the German language.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 monthsChildren 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
Conners Psychopathology ScoresPre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 monthsConners 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

Secondary

MeasureTime frameDescription
Perceived CriticismPre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 monthsAssessment of children's perceived criticism: * 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
Parental Stress (ESF)Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 monthsParent Stress Questionnaire: * 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
Social SupportPre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 monthsChildren's social support scale: * 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
Blood/saliva samples for possible genetic correlates of therapy responseEnd of therapy after 36 sessionsEither saliva sampling or blood samples for genotyping of ADHD candidate genes to establish possible correlates of therapy response
CortisolPre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 monthAssessed with hair-samples: * 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
Self-ConceptPre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 monthsChildren's self-concept interview: * 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

Countries

Germany

Contacts

Primary ContactHanna Christiansen, PhD
christih@staff.uni-marburg.de0049 6421 28
Backup ContactWinfried Rief, PhD
rief@staff.uni-marburg.de0049 6421 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026