Douglas 1986.

Study characteristics
Methods	5‐day cross‐over trial with 2 interventions: MPH (0.3 mg/kg capsules each dose, morning + afternoon) placebo (100 mg lactose capsules) Phases Screening session about a week before testing (given practice on all tasks in the test battery; appropriate level was established for each child on tasks graded for difficulty level) 5 days of testing. Children received drug (D) or placebo (P) according to 1 of 4 possible orders: (1) PDDPP: (2) DPPDD; (3) DDPPD; (4) PPDDP. Testings were received each morning according to 4 test orders: (1) ABCDEF; (2) ACBEDF; (3) ADEBCF and (4) AEDCBF Before the trial was undertaken, 16 drug and test order combinations for the morning test battery were ordered randomly. As participants entered the trial, they were assigned to these drug‐plus‐test order combinations until all 16 participants had been assigned. The order of the 2 tests in the afternoon battery (arithmetic and word discovery) was alternated over children, and each child received tests in the same order over 5 days of testing
Participants	Number of participants screened: not stated Number of participants included: 16 (15 boys, 1 girl) Number of participants followed up: 16 Number of withdrawals: not stated Diagnosis of ADHD: DSM‐III (subtypes not stated) Age: mean 9.2 years (range 6‐11.6) IQ: mean 103.19 (range 89‐125) MPH‐naive: 13 (81%) Ethnicity: not stated Country: Canada Setting: outpatient clinic Comorbidity: not stated Comedication: not stated Other sociodemographics: children’s families varied from I to V on the Hollingshead and Redlich Index (with most families falling within level III to IV (V being the poorest) Inclusion criteria Met criteria for a DSM‐III diagnosis of ADHD (American Psychiatric Association, APA 1980) Had to receive ratings > 1.5 (on a 0‐3 scale) on the Hyperactivity Index of Revised Conners' Parent and Teacher Rating Scales Participants were referred to the Hyperactivity Project at Montreal Children’s Hospital by paediatricians or school personnel. Referral was based on presence of the following symptoms: inattentiveness impulsivity hyperactivity restlessness poor compliance and poor self control Symptoms were of sufficient severity to prompt referring physicians to consider a trial on stimulant medication Exclusion criteria Psychosis Serious visual, auditory or language deficits Diagnosed as brain damaged Restless behaviour attributable to emotional problems or a stressful home environment Appearance of symptoms before age 5 and evidence that symptoms were chronic and pervasive
Interventions	Participants were randomly assigned to 1 of 4 possible orders of drug (D) or placebo (P): (1) PDDPP; (2) DPPDD; (3) DDPPD; (4) PPDDP. On days when participants were assigned to active medication, they received a capsule containing the quantity of medication closest to a calculated dose of 0.3 mg/kg for each dose (morning and afternoon) Mean MPH dosage: not stated Administration schedule: morning capsule administered approximately 1 h after breakfast and 45 min before morning test battery was administered. Second capsule, identical to the morning capsule, administered before child left for lunch and returned to school. Time between morning and afternoon capsule was approximately 3½ h Duration of each medication condition: 1 day each; in all 2 or 3 days, depending on order of drugs assigned Washout before trial initiation: 24 h before screening, 48 h before first testing day Titration period: none Treatment compliance: capsule administered by examiner
Outcomes	ADHD symptoms Hyperactivity Index from CTRS‐R: examiner‐rated, at end of each morning of individual testing Hyperactivity Index from CTRS‐R: teacher‐rated, each afternoon Score for the Index is based on the mean of item ratings on a 4‐point scale (0‐3)
Notes	Sample calculation: no Ethics approval: yes Key conclusions of trial authors Results indicate MPH‐induced improvement in most measures Drug‐induced changes reflected increased output, accuracy and efficiency and improved learning acquisition. Evidence of increased effort and self‐correcting behaviours was found It is argued that review authors have underestimated the potential of stimulants to improve performance of ADD‐H children on academic, learning and cognitive tasks Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: not stated Funding source: supported by grant number MA 6913, from the Medical Research Council of Canada Email correspondence with trial authors: July 2014. Emailed trial authors to ask for additional information. Received information on ethics approval, but first trial author was not able to provide additional data or information on the trial
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	High risk	Capsule was administered by examiner
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	In a few cases in which data were missing, scores from 1 or 2 days were used to compute means for drug and placebo conditions. No information on dropout rate Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias)	Unclear risk	No protocol obtained