Oesterheld 1998.

Study characteristics
Methods	Cross‐over trial with 3 interventions: MPH lactose placebo vitamin C placebo Phases: 5‐day trial lasting for 3 consecutive weeks, with 2 medication‐free days between phases
Participants	Number of participants screened: 30 Number of participants included: 4 Number followed up: 4 (2 boys, 2 girls) Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (combined (66.7%), hyperactive‐impulsive (0%), inattentive (33.3%)) Age: mean 8.25 years (range 5‐11) IQ: mean 72.5 (range 63‐79) MPH‐naive: 100% Ethnicity: Native American (100%) Country: USA Setting: outpatient clinic (residential school, laboratory classroom) Comorbidity: not stated Comedication: no Other sociodemographics: not living with family Inclusion criteria Native Americans 5‐12 years of age Residing at the residential school for 6 months DSM‐IV ADHD diagnosis Diagnosis of foetal alcohol syndrome, partial foetal alcohol syndrome or alcohol‐related birth defects according to criteria from the Fetal Alcohol Study Group of the Research Society of Alcoholism (1989) Exclusion criteria Pregnancy Lactose intolerance Prior psychotropic medication use Bipolar disorder Acute and chronic medical or neurological disorders Current history of seizures Lead levels > 9 mcg/dL Height and weight ≤ 3rd percentile IQ < 60
Interventions	Participants were randomly assigned to different possible drug condition orders of MPH (0.6 mg/kg), lactose placebo and vitamin C placebo Mean MPH dosage: not stated (range 10 mg/d to 17.5 mg/d) Administration schedule: 7:30 am, 11:00 am and 2:00 pm Duration of each medication condition: 5 days for 3 consecutive weeks Washout before trial initiation: not stated Medication‐free period between interventions: 2 days Titration period: none. Fixed dose Treatment compliance: medication given by nurse (directly observed treatment)
Outcomes	ADHD symptoms CPRS (48 items) and CTRS (39 items): both completed daily in each trial period by carers and teachers, respectively Non‐serious AEs Barkley Side Effects Questionnaire was completed by both teacher and carer before treatment
Notes	Sample calculation: no Ethics approval: yes; Human Subjects Committee of the University of South Dakota's School of Medicine and the Research Committee of the Black Hills Children's Home Society Key conclusion of trial authors When foetal alcohol syndrome and ADHD co‐exist, ADHD symptoms of native children may respond to standard treatment with MPH without major side effects Comment from review authors MPH was prepared to the nearest 2.5 mg using regular 5 mg and 10 mg MPH tablets that had been crushed and placed within gelatin capsules, which may result in uncertainty of actual dose administered 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 University of South Dakota/USF‐Mini Grant Email correspondence with trial authors: not able to find email addresses for trial authors because information is missing from the paper. Not possible to find on the Internet, etc.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The order of the trials was randomly determined
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	School carers, nurses, teachers and researchers were blinded as to whether treatment consisted of placebo or active agent. All agents were placed in identical capsules
Blinding of outcome assessment (detection bias) All outcomes	Low risk	On each day of each trial, a teacher, blinded to evaluation data, rated the child's behaviour in school using CTRS (39 items). The caregiver, blinded to evaluation data, completed CPRS (48 items) on a daily basis. School carers, nurses, teachers and researchers were blinded as to whether treatment consisted of placebo or active agent. All agents were placed in identical capsules
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias)	Unclear risk	No protocol identified