Chronis 2003.

Study characteristics
Methods	8‐week within‐participant, placebo‐controlled, randomised, cross‐over trial (summer treatment camp) with 3 interventions: MPH MAS (Adderall) placebo Phases: 2‐week baseline assessment followed by 6‐week medication trial
Participants	Number of participants screened: 48 Number of participants included: 21 (19 boys, 2 girls) Number of participants followed up: not stated Number of withdrawals: not stated Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: mean 10.3 years (±1.9, range 6‐12) IQ: mean 109.9 (± 18.8) MPH‐naive: 14 children had received MPH before start of the trial Ethnicity: white (100%) Country: USA Setting: outpatient clinic (summer treatment programme) Comorbidity: learning problems (42.9%), ODD (66.7%), CD (23.8%) Comedication: not stated Other sociodemographics: (median family income = USD 35,000/year (< USD 15,000/year to > USD 100,000/year); 66.7% of parents married Inclusion criteria DSM‐IV diagnosis of ADHD Exclusion criteria None stated
Interventions	Participants were randomly assigned to 1 of 7 possible drug condition orders of IR‐MPH, MAS (Adderall) and placebo Placebo at 7:30 am, 11: 30 am and 3:30 pm 0.3 mg/kg MPH at 7:30 am, 11:30 am and 3:30 pm 0.3 mg/kg MPH at 7:30 am and 11:30 am with 0.15 mg/kg at 3:30 pm 0.3 mg/kg MPH at 7:30 am only 0.3 mg/kg MAS at 7:30 am and at 3:30 pm 0.3 mg/kg MAS at 7:30 am with 0.15 mg/kg received at 3:30 pm 0.3 mg/kg MAS at 7:30 am only Mean MPH dosage: not stated Administration schedule: MPH once, twice or 3 times daily according to the randomisation procedure Duration of each medication condition: all participants received medication each Monday through Friday throughout a period of 6 weeks for a 24‐day clinical assessment period. Assessment period was divided into three, 8‐day segments. Within each segment, placebo occurred twice and each other condition occurred once, with the order of conditions randomly assigned on a daily basis Washout before trial initiation: not stated Medication‐free period between interventions: none Titration period: none Treatment compliance: not stated
Outcomes	ADHD symptoms IOWA CRS: rated by counsellors at the end of each day, by teachers after the classroom period each day and by parents in the evening Non‐serious AEs Pittsburgh Side Effects Rating Scale: rated by counsellors and teachers daily, rated by parents each evening with the addition of an item assessing difficulty falling asleep
Notes	Sample calculation: no Ethics approval: yes Comments from trial authors Additional (late‐afternoon) stimulant dose has beneficial effects on parent‐child interactions At the end of the summer treatment programme for the 21 children, it was determined that 5 children did not show a sufficient positive response Key conclusions of trial authors Single morning dose of MAS (Adderall) had effects for an entire school day Single dose of MAS (Adderall) was equivalent to IR‐MPH twice/d Comments from review authors No mean MPH dose Behavioural intervention was also implemented during the entire 8‐week trial period As intervention sequences were switched on a daily basis according to randomisation, we did not ask about first‐period data from this trial 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: a grant from Shire‐Richwood Pharmaceuticals, Incorporated ‐ manufacturer of Adderall ‐ and from the NIMH Email correspondence with trial authors: July 2014. Emailed trial authors twice to request additional information. Trial author was not able to provide us with additional data
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Randomized by day”, no description of how randomisation took place
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	To ensure blinding, placebo capsules were given at 11:30 am in the MAS conditions and for applicable doses in the other conditions. Active medication and placebo were disguised in opaque gelation capsules by a local pharmacy and were dispensed in daily pill reminders by the trial doctor. Furthermore, children were informed that they would be receiving 2 different kinds of medication to see how well they worked, and that some days they would receive inactive pills, but that they, their counsellors or teachers and their parents would not know what kind of pill they would get each day
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Children were informed that they would be receiving 2 different kinds of medication to see how well they worked, and that some days they would receive inactive pills, but that they, their counsellors or teachers and their parents would not know what kind of pill they would get each day
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No mention of dropout Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias)	Low risk	All outcomes reported