Fabiano 2007.

Study characteristics
Methods	Randomised, double‐blind, within‐participant design, cross‐over trial with 2 interventions: MPH placebo Phases: 0.15 mg/kg, 0.30 mg/kg and 0.60 mg/kg. Medication was randomly assigned for each child and varied daily during a 9‐week summer treatment programme
Participants	Number of participants screened: not stated Number of participants included: 48 (44 boys, 4 girls) Number of participants followed up: 47 Number of withdrawals: 1 Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: mean 9.35 years (SD 1.98, range 5‐12) IQ: 106.33 (SD 14.61) MPH‐naive: not stated Ethnicity: white (79%); African American (12.5%); Hispanic, Native American or mixed race (8.5%) Country: USA Setting: outpatient clinic (summer treatment programme) Comorbidity: not stated Comedication: not stated Other sociodemographics: none Inclusion criteria DSM‐IV, diagnostic criteria for ADHD Estimated full‐scale IQ ≥ 80 No documented adverse response or non‐response to MPH No medical condition that would contraindicate use of MPH Exclusion criteria None stated
Interventions	Participants were randomly assigned to 1 of 3 possible drug condition orders of IR‐MPH (0.15 mg/kg, 0.30 mg/kg and 0.60 mg/kg) and placebo Mean MPH dosage: 5.03 mg (range 2.5‐10), 10.8 mg (range 5‐20) and 21 mg (range 12.5‐30) Administration schedule: 3 times daily (7:45 am, 11:45 pm and 3:45 pm) Duration of each medication condition: varied daily Washout before trial initiation: none Titration period: none Treatment compliance: not stated
Outcomes	ADHD symptoms IOWA CRS (inattention‐impulsivity‐overactivity): teacher‐ and observer‐rated, daily General behaviour IOWA CRS (oppositional defiance): teacher‐ and observer‐rated, daily Non‐serious AEs Pittsburgh Side Effects Rating Scale: teacher‐rated daily Clinically significant AEs: observer‐rated daily
Notes	Sample calculation: no Ethics approval: yes Comments from trial authors "The study was conducted in an analogue classroom setting" (as opposed to a community classroom) "The treatments used were of short duration" "Observers and raters were blind to medication condition but not to behaviour modification conditions" "Ratings from the Pittsburgh Side Effects Rating Scale were averaged across days within drug condition (regardless of behaviour modification condition) for the 47 children. One participant's medication was discontinued because of parental concerns about side effects (mainly buccal‐lingual movements) after 2 days of treatment, and 1 child's afternoon dose was reduced on 0.60 mg/kg days because of parent‐reported anxiety and mood symptoms. No other children had side effects rated by the teacher at an average level of moderate or severe" Comments of review authors This trial of placebo versus MPH was conducted during different conditions of behaviour modification. We should consider whether to use only data from the non‐behaviour modification condition or data from all conditions Inclusion of MPH responders only/exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes Any withdrawals due to AEs: yes, 1 (withdrawn by parents due to concern about side effects and not included in the analysis) Funding source: NIMH grant MH62946 Email correspondence with trial authors: April 2014. We obtained supplemental information regarding risk of bias. No further information was received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation and allocation concealment were completed with a random number generator by a researcher not involved in treatment
Allocation concealment (selection bias)	Low risk	Randomisation and allocation concealment were completed with a random number generator by a researcher not involved in treatment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Medication assessment procedure was double‐blinded" (p 201) "children, their parents, and all clinical staff members were blinded to medication condition" (p 202) Medication was prepared in opaque capsules by a pharmacist not otherwise involved in the trial. It was administered to children by research staff who were not involved in administration of behavioural treatment nor in daily activities
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Observers and raters were blinded to medication conditions
Incomplete outcome data (attrition bias) All outcomes	High risk	One child's parents elected to stop medication for the child after 2 days because of their concerns about possible side effects of the medication. This child was not included in the analyses 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 was published