ADHDPhase 2NCT01879644
Neurofeedback Study ADHD
A Phase 2 study testing NF, SM and PE in people with ADHD, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- ADHD
- What is being tested?
- NF, SM and PE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with ADHD aged 7 to 11
- full command of the German language.
Who cannot join
- IQ below 80
- Children with symptoms of:
- inattention,
- hyperactivity or
- impulsivity due to other medical reasons such as:
- hyperthyreosis,
Show all 10Show fewer
- autism,
- epilepsy,
- brain disorders and
- any genetic or medical disorder associated with externalizing behavior that mimics ADHD.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Philipps-University Marburg, Department of Psychology, Clinical Child and Adolescent Psychology
Marburg, Hesse, 35037
Hanna Christiansen, PhD, 0049 6421 28 ext. 23706, christih@staff.uni-marburg.de
Winfried Rief, PhD, 0049 6421 28 ext. 23641, rief@staff.uni-marburg.de
About this study
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
- ADHD
- Being tested
- NF, SM, PE, SU
- Keywords
- ADHD, Neurofeedback, Self-Management, Parental Psychoeducation, Social Support
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NFBehavioural
SMBehavioural
PEBehavioural
SUBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback with Psychoeducation (NF + PE) | Active comparator | Neurofeedback plus Parental Psychoeducation Receives: Behavioral: NF; Behavioral: PE |
| Self-Management with Psychoeducation (SM + PE) | Active comparator | Self-management + parental psychoeducation Receives: Behavioral: SM; Behavioral: PE |
| NF+PE and additional Social Support (SU) | Active comparator | Neurofeedback + parental psychoeducation enhanced with social support Receives: Behavioral: NF; Behavioral: PE; Behavioral: SU |
| SM+PE and additional Social Support (SU) | Active comparator | Self-management + parental psychoeducation enhanced with social support Receives: Behavioral: SM; Behavioral: PE; Behavioral: SU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: End of therapy after 36 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879644
- Sponsor's protocol ID
- NF-HC
- Status last verified
- Nov 2016
- First submitted
- 28 May 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25505396Korfmacher 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.
PubMed 36061275
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback Study ADHD
- ClinicalTrials.gov ID
- NCT01879644
- Acronym / sponsor ID
- NF-HC
- Conditions
- ADHD
- Keywords
- ADHD, Neurofeedback, Self-Management, Parental Psychoeducation, Social Support
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback with Psychoeducation (NF + PE) | Active comparator | Behavioral: NF, Behavioral: PENeurofeedback plus Parental Psychoeducation |
| Self-Management with Psychoeducation (SM + PE) | Active comparator | Behavioral: SM, Behavioral: PESelf-management + parental psychoeducation |
| NF+PE and additional Social Support (SU) | Active comparator | Behavioral: NF, Behavioral: PE, Behavioral: SUNeurofeedback + parental psychoeducation enhanced with social support |
| SM+PE and additional Social Support (SU) | Active comparator | Behavioral: SM, Behavioral: PE, Behavioral: SUSelf-management + parental psychoeducation enhanced with social support |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with ADHD aged 7 to 11
- full command of the German language.
Key exclusion criteria (10 listed)
- IQ below 80
- inattention,
- hyperactivity or
- impulsivity due to other medical reasons such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NF | Behavioural | NF+PE and additional Social Support (SU), Neurofeedback with Psychoeducation (NF + PE) |
| SM | Behavioural | SM+PE and additional Social Support (SU), Self-Management with Psychoeducation (SM + PE) |
| PE | Behavioural | NF+PE and additional Social Support (SU), Neurofeedback with Psychoeducation (NF + PE), SM+PE and additional Social Support (SU), Self-Management with Psychoeducation (SM + PE) |
| SU | Behavioural | NF+PE and additional Social Support (SU), SM+PE and additional Social Support (SU) |
Primary outcome
Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)
Time frame: 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
Time frame: 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
6 secondary outcomes
Social Support
Time frame: Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months
Self-Concept
Time frame: Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months
Perceived Criticism
Time frame: Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months
Parental Stress (ESF)
Time frame: Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months
Cortisol
Time frame: 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
Time frame: End of therapy after 36 sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Results publication: PubMed 25505396Christiansen 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.
- Derived from this study: PubMed 36061275Korfmacher 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.
- Comparison of Neurofeedback and Self-Management Training in an outpatient clinic.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NF, SM and PE in people with ADHD, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Christiansen, PhD (0049 6421 28 ext. 23706, christih@staff.uni-marburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera) (time frame: Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879644, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.