Brown 1985.
Study characteristics | ||
Methods | 12‐week, randomised, parallel trial
Cognitive training programme: individual, twice‐weekly, 1‐h sessions for a total of 24 sessions spanning a 3‐month period |
|
Participants | Number of participants included: MPH + cognitive training 10, cognitive training 10 Number of participants followed up: MPH + cognitive training 10, cognitive training 10 Number of withdrawals: MPH + cognitive training 0, cognitive training 0 Diagnosis of ADHD: DSM‐III (types not stated) Age: mean 11.36 years (range 6.4‐11.9) IQ: 101.92 (range 91‐136) MPH‐naive: not stated Ethnicity: not stated Country: USA Setting: not stated Comorbidity: not stated Comedication: no. No child was receiving any psychopharmacological treatment Other sociodemographics: none. No significant differences in baseline demographics between the 2 groups Inclusion criteria
Exclusion criteria
|
|
Interventions | Participants were randomly assigned to MPH + cognitive training or to cognitive training only Mean MPH dosage: 0.3 mg/kg (range 5 mg/d‐15 mg/d) Administration schedule: twice daily (morning and lunch) Duration of intervention: 12 weeks + 3 months (only with medication) Titration period: none Treatment compliance: not stated Cognitive training programme: individual, twice‐weekly, 1‐h sessions for a total of 24 sessions spanning a 3‐month period |
|
Outcomes |
ADHD symptoms
|
|
Notes | Sample calculation: no Ethics approval: no information Key conclusion of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: no Funding source: research supported by US Public Health Services Grant from the NIMH, and by the Biomedical Research Award from the NIH. MPH provided by CIBA‐GEIGY Corporation, Summit, New Jersey |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label MPH |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants followed up Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Unclear risk | No protocol/design published |