Ialongo 1994.

Study characteristics
Methods	14‐week, parallel trial with 3 arms: placebo LD‐MPH (stimulant therapy) HD‐MPH (stimulant therapy)
Participants	Number of participants screened: not stated Number of participants included: 48 (35 boys, 13 girls). A sample of 21 non‐clinical controls (13 boys and 8 girls) was also included in the trial Number of withdrawals: 7 families dropped out from pre‐test to post‐test: HD‐MPH 3, placebo 4 Numper of participants followed up: LD‐MPH 16, HD‐MPH 13, placebo 12 Diagnosis of ADHD: DSM‐III‐R (subtype not stated) Age: mean 7.97 years (SD 1.4, range 7‐11) IQ: ≤ 70 MPH‐naive: 98% Ethnicity: white (78.0%), African American (12.2%), Hispanic (9.8%) Country: USA Setting: outpatient clinic Comorbidity: CD 5, ODD 12 Comedication: no Other sociodemographics: middle‐income families. No significant differences between treatment groups or between treatment groups and dropouts in any participant and/or demographic characteristics at pre‐test, with the exception of ethnicity. A significantly greater proportion of African American children were included in the placebo condition than in the high‐dose condition Inclusion criteria Diagnosis of ADHD according to DSM‐III‐R Exact agreement between 2 assessors (paediatrician and psychologist) with respect to ADHD diagnosis Score on Hyperkinesis Indices of the CPRS and CTRS ≥ 2 SD above published means Exclusion criteria Comorbid anxiety and/or depressive disorder Gross physical impairment Intellectual deficits Psychosis in child or parents IQ < 70 (measured with the Peabody Picture Vocabulary Test ‐ Revised)
Interventions	Participants were randomly assigned to 3 treatment conditions: medication placebo alone (n = 16), LD‐MPH (0.4 mg/kg) stimulant therapy (16) or HD‐MPH (0.8 mg/kg) stimulant therapy 16 Duration of intervention: 14 weeks Titration period: no Treatment compliance: 1 check on medication compliance consisted of periodic dispensing of medication over the course of the trial during follow‐up visits to staff paediatricians. In addition, a medical compliance questionnaire was completed anonymously by parents 1 month after post‐test assessments. 91.9% of parents in the medication conditions indicated that their child took the stimulant medication almost every day throughout the trial, whereas nearly all remaining families reported average usage of 3‐4 days a week
Outcomes	ADHD symptoms CPRS CTRS General behaviour CTRS, Conduct problems
Notes	Sample calculation: no information Ethics approval: no information Key conclusion of trial authors In contrast to placebo, although MPH resulted in significantly greater amelioration of many of the core features of ADHD, we found no evidence of a decrease in perceived competence, or of an increase in external or unknown explanations of control or dysphoria at post‐test (i.e. 14 weeks later) Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: yes, 7 families dropped out due to intolerable side effects or lack of treatment efficacy Funding source: not declared Email correspondence with trial authors: August 2013 and January 2014. We emailed trial authors to request a copy of the protocol and additional information on, for example, the randomisation procedure and funding (Ramstad 2013a [pers comm]).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomly assigned
Allocation concealment (selection bias)	Unclear risk	No information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	All medication was dispensed in a double‐blinded fashion
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All medication was dispensed in a double‐blinded fashion
Incomplete outcome data (attrition bias) All outcomes	High risk	No description of imputation method Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias)	Unclear risk	No protocol identified