Brown 1984a.

Study characteristics
Methods	4‐week cross‐over trial with 2 interventions: MPH placebo Phases: 2 weeks of placebo and 2 weeks of MPH treatment with sequence according to randomisation
Participants	Number of participants screened: not stated Number of participants included: 11 (all boys) Number of participants followed up: 11 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐III Age: mean 10 years, 5 months (range 9 years 1 month‐12 years 1 month) IQ: > 80 MPH‐naive: not stated Ethnicity: not stated Country: USA Setting: outpatient clinic Comorbidity: not stated Comedication: not stated Other sociodemographics: none Inclusion criteria DSM‐III diagnosis of ADD Exclusion criteria Known neurological or sensory impairment IQ > 80
Interventions	Participants were randomly assigned to 1 of 2 possible drug condition orders of 0.3 mg/kg MPH and placebo Mean MPH dosage: not stated Administration schedule: twice/d Duration of each medication condition: 2 weeks Washout before trial initiation: not stated Medication‐free period between interventions: time of day the pills were taken not stated Titration period: none Treatment compliance: not stated
Outcomes	ADHD symptoms CPRS: rated at the end of each school week CTRS: rated at the end of each school week Non‐serious AEs Cardiovascular measures: heart rate, SBO and DBP. Heart rate was recorded after the child had rested for 5 min by placing a stethoscope over the precordium and measuring the rate for 1 minute. BP was obtained with a sphygmomanometer with the child seated after he had rested 5 minutes. Tested at the end of each 2‐week drug period “No deleterious side effects”
Notes	Sample calculation: no Ethics approval: yes Comments from trial authors Of additional importance in the present trial was the finding that MPH had no deleterious side effects and was well tolerated by all children participating in the research project Table 3 shows that individual variations in heart rate and BP associated with MPH trials are quite large Key conclusions of trial authors Results demonstrated significant improvement in sustained attention and impulse control, as well as in ratings of social behaviour, by both teachers and parents Cardiovascular functioning did not significantly increase as a function of MPH 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: funded by NIMH and NIH. Placebo and MPH were supplied by CIBA‐GEIGY Corporation, Summit, New Jersey Email correspondence with trial authors: November 2013. We received additional information regarding ethics approval, sample calculation, etc., from trial authors. However, it was not possible to receive all requested data, as the trial author no longer possessed raw data from the trial.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The sequence of the 2 medication conditions was randomly assigned, but no information was provided on methods
Allocation concealment (selection bias)	Low risk	Triple blinding; dosage was administered twice daily in the form of opaque capsules packaged by hospital pharmacists to conceal the contents
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Child and parent, teacher and the physician were blinded to the child’s medication condition
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Physician was blinded to the child’s medication concealment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data provided on all 11 participants Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias)	Low risk	No indication of selective reporting