Clinical trial NCT01879644: Neurofeedback Study ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: ADHD
Keywords: ADHD
Neurofeedback
Self-Management
Parental Psychoeducation
Social Support
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)
timeFrame: Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 months
measure: Conners Psychopathology Scores
timeFrame: Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months
Secondary outcomes:
measure: Social Support
timeFrame: Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months
measure: Self-Concept
timeFrame: Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months
measure: Perceived Criticism
timeFrame: Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months
measure: Parental Stress (ESF)
timeFrame: Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months
measure: Cortisol
timeFrame: Pre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 month
measure: Blood/saliva samples for possible genetic correlates of therapy response
timeFrame: End of therapy after 36 sessions
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps-University Marburg, Department of Psychology, Clinical Child and Adolescent Psychology
state: Hessen
Study officials:
References:
citation: 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.
citation: Korfmacher 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.