Attention Deficit Disorder
Conditions
Keywords
AD/HD in Children and Adolescents
Brief summary
The purpose of this study is to investigate if neurofeedback and working memory training improves core symptoms of ADHD in children and adolescents.
Detailed description
This study investigates two types of Neurofeedback (NF), one well-established and well-researched protocol called Slow Cortical Potential NF (SCP), and a newer and less researched, yet popular among private clinicians, the so-called live z-score training (LZT). These methods are compared to working memory training (WMT) and a passive control condition, treatment-as-usual only (TAU). The active conditions (SCP/LZT/WMT) are delivered high frequent, with 5 sessions/week, for a total of 25 sessions. Outcomes measures are taken at Preintervention and Postintervention, as well as at a 6-month follow-up assessment.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Clinical AD/HD diagnose according to DSM-IV-TR and K-SADS interview, 9-17 years old, unmedicated or under stable medication with stimulants or corresponding since at least one month.
Exclusion criteria
* IQ \<70 (WISC-IV or WAIS-IV), clinically instable psychiatric state e.g. severe depression, OCD, self-injurious behaviour, bipolar disorder, severe somatic (neurologic) disease, very limited knowledge in the Swedish language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conners 3 ADHD-index | Up to seven months | Presented below are the within-group differences from baseline to 6-month follow up, for the ADHD-index of the Conners-3. Positive numbers indicate symptom improvements. \*The ADHD-index raw score can range from 0-20, with higher score indicating greater symptom severity. The Reliable Change Index (RCI) is 2.88. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SCP Training Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training
SCP training | 51 |
| Live Z-score Training Neurofeedback 2 (NF2) Live Z-score training (LZT)
Live Z-score training | 50 |
| WM Training Working Memory training (WMt)
WM training | 51 |
| Waiting-list Treatment as usual only | 50 |
| Total | 202 |
Baseline characteristics
| Characteristic | Total | Waiting-list | Live Z-score Training | WM Training | SCP Training |
|---|---|---|---|---|---|
| Age, Continuous Range | 12.40 years | 12.21 years | 12.41 years | 12.61 years | 12.35 years |
| Age, Customized Mean (Sd) | 12.40 years STANDARD_DEVIATION 2.51 | 12.21 years STANDARD_DEVIATION 2.41 | 12.41 years STANDARD_DEVIATION 2.3 | 12.61 years STANDARD_DEVIATION 2.74 | 12.35 years STANDARD_DEVIATION 2.65 |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Sex: Female, Male Female | 49 Participants | 14 Participants | 13 Participants | 9 Participants | 13 Participants |
| Sex: Female, Male Male | 153 Participants | 36 Participants | 37 Participants | 42 Participants | 38 Participants |
| Symptom Severity - Conners3 ADHD-index Conners-3 Parent-rating | 81.86 units on a scale STANDARD_DEVIATION 11.82 | 82.84 units on a scale STANDARD_DEVIATION 10.91 | 82.84 units on a scale STANDARD_DEVIATION 9.16 | 81.32 units on a scale STANDARD_DEVIATION 12.85 | 80.51 units on a scale STANDARD_DEVIATION 13.91 |
| Symptom Severity - Conners3 ADHD-index Conners-3 Self-rating | 69.67 units on a scale STANDARD_DEVIATION 15.94 | 70.06 units on a scale STANDARD_DEVIATION 15.79 | 67.12 units on a scale STANDARD_DEVIATION 15.15 | 72.26 units on a scale STANDARD_DEVIATION 16.67 | 69.24 units on a scale STANDARD_DEVIATION 16.15 |
| Symptom Severity - Conners3 ADHD-index Conners-3 Teacher-rating | 64.92 units on a scale STANDARD_DEVIATION 14.55 | 66.67 units on a scale STANDARD_DEVIATION 14.61 | 65.83 units on a scale STANDARD_DEVIATION 14.88 | 64.27 units on a scale STANDARD_DEVIATION 15.47 | 62.76 units on a scale STANDARD_DEVIATION 13.37 |
| Symptom Severity (Range) Parent-Rating | 89 units on a scale | 89 units on a scale | 88.5 units on a scale | 89 units on a scale | 89 units on a scale |
| Symptom Severity (Range) Self-Rating | 69 units on a scale | 72 units on a scale | 62.5 units on a scale | 72.5 units on a scale | 67 units on a scale |
| Symptom Severity (Range) Teacher-Rating | 64 units on a scale | 67 units on a scale | 65 units on a scale | 65 units on a scale | 59 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 50 | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 0 / 51 | 0 / 50 | 0 / 51 | 0 / 50 |
| serious Total, serious adverse events | 0 / 51 | 0 / 50 | 0 / 51 | 0 / 50 |
Outcome results
Conners 3 ADHD-index
Presented below are the within-group differences from baseline to 6-month follow up, for the ADHD-index of the Conners-3. Positive numbers indicate symptom improvements. \*The ADHD-index raw score can range from 0-20, with higher score indicating greater symptom severity. The Reliable Change Index (RCI) is 2.88.
Time frame: Up to seven months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SCP Training | Conners 3 ADHD-index | Conners3-ADHD-index Teacher-rating | 1.32 score on a scale |
| SCP Training | Conners 3 ADHD-index | Conners3-ADHD-index Self-rating | 1.21 score on a scale |
| SCP Training | Conners 3 ADHD-index | Conners3-ADHD-index Parent-rating | 1.81 score on a scale |
| Live Z-score Training | Conners 3 ADHD-index | Conners3-ADHD-index Teacher-rating | 3.37 score on a scale |
| Live Z-score Training | Conners 3 ADHD-index | Conners3-ADHD-index Parent-rating | 2.26 score on a scale |
| Live Z-score Training | Conners 3 ADHD-index | Conners3-ADHD-index Self-rating | 1.37 score on a scale |
| WM Training | Conners 3 ADHD-index | Conners3-ADHD-index Self-rating | 1.44 score on a scale |
| WM Training | Conners 3 ADHD-index | Conners3-ADHD-index Parent-rating | 2.22 score on a scale |
| WM Training | Conners 3 ADHD-index | Conners3-ADHD-index Teacher-rating | 2.80 score on a scale |
| Waiting-list | Conners 3 ADHD-index | Conners3-ADHD-index Teacher-rating | -0.66 score on a scale |
| Waiting-list | Conners 3 ADHD-index | Conners3-ADHD-index Self-rating | 0.78 score on a scale |
| Waiting-list | Conners 3 ADHD-index | Conners3-ADHD-index Parent-rating | 0.60 score on a scale |