Symons 2007.

Study characteristics
Methods	Prospective, randomised, double‐blind, placebo‐controlled, cross‐over, single‐case designs were used to evaluate MPH administration for 3 school‐aged children with cerebral palsy and comorbid ADHD symptoms LD‐MPH HD‐MPH placebo Phases: 4 (including baseline)
Participants	Number of participants screened: not stated Number of participants included: 2 (1 boy, 1 girl) Number of participants followed up: 2 Number of withdrawals: none Diagnosis of ADHD: DSM‐IV (combined (100%), hyperactive‐impulsive (0%), inattentive (0%)) Age: mean 10.4 years (range 9‐11) IQ: > 70. Participant 2 = 92 non‐verbal and 96 performance non‐verbal (range not stated) MPH‐naive: not stated Ethnicity: not stated Country: USA Setting: outpatient clinic Comorbidity: cerebral palsy (100%), mild cognitive impairment (100%), autism spectrum disorder (50%), physical impairment (50%), learning disability (50%), other health impairment (50%) Comedication: not stated Other sociodemographics: none Inclusion criteria DSM‐IV diagnosis of ADHD Cerebral palsy Attending public elementary schools Exclusion criteria None stated
Interventions	Participants were randomly assigned to 1 of 3 possible drug condition orders of MPH (low or high dose) and placebo Mean MPH dosage: 2 doses of MPH administered: LD‐MPH (0.3 mg/kg) and HD‐MPH (0.5 mg/kg) Administration schedule: once daily, mornings, before the child’s school arrival Duration of each medication condition: order of drug/placebo administration was randomly assigned, and administration was provided for 5 consecutive school days in each condition. Drug treatment was not administered on weekends For participant 2, the order of administration was as follows: baseline, LD, placebo, HD For participant 3, the order of administration was as follows: baseline, placebo, LD, HD Washout before trial initiation: not stated Medication‐free period between interventions: weekends Titration period: not stated Treatment compliance: not stated
Outcomes	General behaviour Direct observation protocol based on a 10‐s partial interval (1/0) for stereotyped and disruptive behaviours and time sampling for task‐related behaviour was used to code data collected directly from each child’s classroom for two 30‐min sessions on 2 separate days for each week of the trial. Student and teaching staff behaviours were recorded using handheld digital cameras. An observer designated as the primary observer coded all videotaped sessions for that target student. A secondary observer independently coded 20% of randomly selected videotaped sessions for each student Non‐serious AEs No parent or teacher reports described significant side effects associated with either dose level (e.g. changes in sleep, eating, etc.)
Notes	Sample calculation: no Ethics approval: not stated Key conclusions of trial authors LD but not HD‐MPH administration resulted in clinically significant reductions in directly observed stereotyped and disruptive behaviours for 3 elementary school–aged children with cerebral palsy For 2 of the children, stereotyped behaviour was exacerbated during high‐dose administration Finally, no change in attending, as measured by direct observation of task‐related behaviour, was noted Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: not stated Any withdrawals due to AEs: no Funding source: McKnight LandGrant Professorship to the first author Email correspondence with trial authors: May 2014. Emailed trial author to request additional information but have not received a reply
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Order of drug/placebo administration was randomly assigned
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Parents, school personnel (i.e. teachers, teacher assistants) and research assistants responsible for observational data collection and coding were kept blind to drug/placebo conditions
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not stated Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias)	Unclear risk	No protocol