Waxmonsky 2008.

Study characteristics
Methods	9‐week therapeutic summer camp consisting of a cross‐over trial with 4 interventions: Placebo MPH 0.15 mg/kg 3 times/d MPH 0.3 mg/kg 3 times/d MPH 0.6 mg/kg 3 times/d Varied daily within a cross‐over design of 3 intensities of behaviour modification therapy No Low High Each lasted 3 weeks
Participants	Number of participants screened: 106 participants in the 2003 and 2004 Summer Treatment Program (University of Buffalo) Number of participants included: 101 (82 boys, 19 girls) (ADHD subgroup 33, ADHD + severe mood dysregulation (SMD) subgroup 68) Number of participants followed up: 99 Number of withdrawals: 2 Diagnosis of ADHD: DSM‐IV (combined (92%), hyperactive‐impulsive (not stated), inattentive (not stated)) Age: mean 8.5 years (range 5‐12) IQ: mean: 105 MPH‐naive: not stated Ethnicity: predominantly white Country: USA Setting: outpatient clinic (Summer Treatment Program) Comorbidity: ODD (54%), CD (12%) Comedication: not stated Other sociodemographics: predominantly middle class Inclusion criteria 5‐12 years of age Participants were required to stop all psychotropic medication 1 week before intake DSM‐IV diagnosis of ADHD ADHD‐related impairment in ≥ 2 realms according to Parent and Teacher Versions of the Impairment Rating Scale (IRS) IQ > 80 Subgroups ADHD: not meeting NIMH criteria for severe mood dysregulation ADHD plus severe mood dysregulation: meeting NIMH criteria for severe mood dysregulation, and having Young Mania Rating Scale (YMRS) score ≥ 12 based on the last month's behaviour and CGI mania severity score ≥ 3 Exclusion criteria History of seizures or other neurological problems Medical history that would involve considerable risk in taking stimulant medication History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder or eating disorder Documented serious adverse reaction to MPH Significant developmental delays or autistic spectrum illness Active use of psychotropic medication for disorders besides ADHD, including use of antidepressants or mood‐stabilising medications Meeting full criteria for the narrow‐phenotype criteria of bipolar disorder or in need of urgent psychiatric treatment (active suicidal ideation). Participants newly identified with major depressive disorder or bipolar disorder on the DISC were directly assessed by an M.D.‐ or Ph.D.‐level clinician
Interventions	Participants attended a Summer Treatment Program each Monday through Friday for 9 weeks. Participants were randomly assigned possible drug condition orders of 0.15 mg/kg 3 times/d, 0.3 mg/kg 3 times/d and 0.6 mg/kg 3 times/d and placebo Average MPH dosages: 5 mg, 10 mg and 18 mg for 0.15 mg/kg, 0.3 mg/kg and 0.6 mg/kg doses, respectively Administration schedule: 7:45 am, 11:45 am and 3:45 pm Duration of each medication condition: each dose varied daily and was repeated 3 or 4 times within each behavioural treatment condition Trial duration: Monday through Friday for 9 weeks, totaling 45 days Washout before trial initiation: 1 week Medication‐free period between interventions: 0‐2 days Titration period: none Treatment compliance: not stated Cointervention: 3 behavioural conditions (no behaviour modification, low‐intensity behaviour modification and high‐intensity behaviour modification) are delivered in random order, with each condition lasting 3 weeks. Parents attended training sessions and implemented behaviour programmes at home
Outcomes	Non‐serious AEs Pittsburgh Side Effects Rating Scale: completed daily by camp staff and parents
Notes	Sample calculation: not stated Ethics approval: yes; by the Health Sciences Institutional Review Board (IRB) of the University of Buffalo Comment from trial authors Limitations: trial duration of only 9 weeks, lack of daily completion of mood assessments and limited generalisation potential due to a population of predominantly white and middle‐class participants. Key conclusion of trial authors MPH and behaviour modification therapy are tolerable and effective treatments for children with ADHD and severe mood dysregulation, but additional treatments may be needed to optimise their functioning. Inclusion of MPH responders only/exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes; excluded patients with prior serious reactions to MPH Any withdrawals due to AEs: 1 withdrew because of tic‐like movements Funding source: NIMH Grant MH62946 and a Klingenstein Third Generation Foundation Fellowship in Child and Adolescent Depression Research Email correspondence with trial authors: August 2014. Obtained supplemental information regarding randomisation, allocation concealment and handling of missing data. Not possible to retrieve safety data
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random orders were generated by computer with the restrictions that each condition occurred at least once in each week. Children were assigned to previously generated codes at enrolment
Allocation concealment (selection bias)	Low risk	Because this was a cross‐over trial in which all children received all conditions multiple times, each child's entire 9‐week schedule was assigned at once. Treatment orders were concealed in an opaque envelope and were stored in a locked cabinet in the medication lab. Only authorised staff members had access to this cabinet.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind. Children, parents and staff were blinded to medication conditions. Placebo and MPH were packaged in identical opaque capsules to maintain blinding.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double‐blind. Parents and staff were blinded to medication conditions.
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias)	Low risk	Outcomes reported according to protocol