Neurofeedback Study ADHD

Study Overview
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Brief Summary
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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.

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: NF
* Behavioral: SM
* Behavioral: PE
* Behavioral: SU


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neurofeedback with Psychoeducation (NF + PE)<br>Neurofeedback plus Parental Psychoeducation | Behavioral: NF<br> <br> Behavioral: PE<br> <br> |
| Active Comparator: Self-Management with Psychoeducation (SM + PE)<br>Self-management + parental psychoeducation | Behavioral: SM<br> <br> Behavioral: PE<br> <br> |
| Active Comparator: NF+PE and additional Social Support (SU)<br>Neurofeedback + parental psychoeducation enhanced with social support | Behavioral: NF<br> <br> Behavioral: PE<br> <br> Behavioral: SU<br> <br> |
| Active Comparator: SM+PE and additional Social Support (SU)<br>Self-management + parental psychoeducation enhanced with social support | Behavioral: SM<br> <br> Behavioral: PE<br> <br> Behavioral: SU<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Support | Children'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 | Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months | 
| Self-Concept | Children'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 | Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months | 
| Perceived Criticism | Assessment 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 | Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months | 
| Parental Stress (ESF) | Parent 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 | Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months | 
| Cortisol | Assessed 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 | Pre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 month | 
| Blood/saliva samples for possible genetic correlates of therapy response | Either saliva sampling or blood samples for genotyping of ADHD candidate genes to establish possible correlates of therapy response | End of therapy after 36 sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Neurofeedback, Self-Management, Parental Psychoeducation, Social Support