Gruber 2007.

Study characteristics
Methods	14‐day, double‐blind, placebo‐controlled, cross‐over trial with 2 interventions: placebo MPH
Participants	Number of participants screened: not stated Number of participants included: 37 (31 boys, 6 girls) Number of participants followed up: 37 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (combined (70%), hyperactive‐impulsive (11%), inattentive (19%)) Age: mean 9.2 years (range 6‐12) IQ: mean 96.7 MPH‐naive: not stated Ethnicity: white (94%), other (6%) Country: Canada Setting: outpatient clinic Comorbidity: ODD (30%), CD (46%), major depressive disorder (5%), general anxiety disorder (3%) Comedication: no Other sociodemographics: none Inclusion criteria ADHD according to DSM‐IV Patient at the Disruptive Behavior Disorders Program and in the outpatient department of Douglas Mental Health University Institute in Montreal Between 6 and 12 years of age Exclusion criteria Score < 80 on the WISC‐III Diagnosis of psychosis Diagnosis of Tourette's syndrome Pervasive developmental disorder Taking any medication other than MPH Previous intolerance/allergic reaction to any psychostimulant
Interventions	Participants were randomly assigned to 1 of 2 possible drug condition orders of MPH and placebo Mean MPH dosage: 0.5 mg/kg/d Administration schedule: twice daily, morning and noon Duration of each medication condition: 7 days Washout before trial initiation: no Medication‐free period between interventions: no Titration period: none Treatment compliance: not stated
Outcomes	General behaviour CBCL, daily Non‐serious AEs Sleep assessment using miniature Antigraphs, measured daily
Notes	Ethics approval: trial was approved by the Research Ethics Board of Douglas Mental Health University Institute Key conclusion of trial authors "Findings of the present trial support the hypothesis that sleep moderates performance on the Continuous Performance Test in children with ADHD receiving placebo or MPH" Comment from review authors Unfortunately, the data are not useable because of how the trial is set up Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes (see exclusion criteria) Any withdrawals due to AEs: no Funding source: this was not an industry‐supported trial Email correspondence with trial authors: February and March 2014. Emailed trial author twice but have not received a reply
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Order of administration (MPH or placebo) was determined by random assignment
Allocation concealment (selection bias)	Unclear risk	No information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"MPH and placebo were prepared in identical coloured gelatin capsules by the hospital’s clinical pharmacist, who was not involved in the study in any other way. Capsules were sealed in individual, daily‐dose envelopes to help control accurate administration"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information
Incomplete outcome data (attrition bias) All outcomes	Low risk	Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias)	Unclear risk	No protocol identified