Neurofeedback Study ADHD

Phase 2

• Conditions: ADHD
• Interventions: Behavioral: NF; Behavioral: SM; Behavioral: PE; Behavioral: SU

• Registration Number: NCT01879644
• Lead Sponsor: Philipps University Marburg Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-18
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15
• Primary Completion: 2018-01
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NF+PE and additional Social Support (SU)	PE	Neurofeedback + parental psychoeducation enhanced with social support
Neurofeedback with Psychoeducation (NF + PE)	NF	Neurofeedback plus Parental Psychoeducation
SM+PE and additional Social Support (SU)	PE	Self-management + parental psychoeducation enhanced with social support
NF+PE and additional Social Support (SU)	NF	Neurofeedback + parental psychoeducation enhanced with social support
SM+PE and additional Social Support (SU)	SU	Self-management + parental psychoeducation enhanced with social support
Neurofeedback with Psychoeducation (NF + PE)	PE	Neurofeedback plus Parental Psychoeducation
Self-Management with Psychoeducation (SM + PE)	SM	Self-management + parental psychoeducation
Self-Management with Psychoeducation (SM + PE)	PE	Self-management + parental psychoeducation
NF+PE and additional Social Support (SU)	SU	Neurofeedback + parental psychoeducation enhanced with social support
SM+PE and additional Social Support (SU)	SM	Self-management + parental psychoeducation enhanced with social support

Primary Outcome Measures

Name	Time	Method
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 months	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
Conners Psychopathology Scores	Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Philipps-University Marburg, Department of Psychology, Clinical Child and Adolescent Psychology; 🇩🇪 Marburg, Hessen, Germany