Wallander 1987.
Study characteristics | ||
Methods | Double‐blind, placebo‐controlled, cross‐over trial with 3 interventions:
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Participants | Number of participants screened: 28 (20 boys, 8 girls) Number of participants included: unclear Number of participants followed up: unclear Number of withdrawals: unclear Diagnosis of ADHD: DSM‐III (subtype not stated) Age: mean 8.4 years (range 6‐12) IQ: mean 79.64 MPH‐naive: 28 (100%) Ethnicity: not stated Country: USA Setting: outpatient clinic and inpatient ward Comorbidity: not stated Comedication: not stated Other sociodemographics: 3.52 (Hollingshead‐Redlich Index) Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of the possible drug condition orders of MPH (0.3 mg/kg and 0.6 mg/kg) and placebo Mean MPH dosage: no information Administration schedule: twice/d, 8:30 am and noon Duration of each medication condition: 12 days for inpatients and 19 days for outpatients (mean 15.25 days) Washout before trial initiation: none Medication‐free period between interventions: 68 h Titration period: none Treatment compliance: no information |
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Outcomes |
General behaviour
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Notes | Sample calculation: none Ethics approval: no information Key conclusions of trial authors
Comment from review authors
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: in part by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) grants and the University of Southern California Faculty Research and Innovation Fund. Email correspondence with trial authors: December 2013. No supplemental information available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Receiving interventions in counterbalanced orders |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Agreement of 90% across all categories had to be reached with this validity observer Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | Protocol not identified |