Pelham 1993a.
Study characteristics | ||
Methods | Cross‐over trial with 2 interventions:
Phases: 3 |
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Participants | Number of participants screened: not stated Number of participants included: 31. Number of participants followed up: 31 (all boys) Number of withdrawals: 0 Diagnosis of ADHD: DSM‐III‐R (therefore no subtype) Age: mean 98.8 months (approximately 8.2 years; range 5.42‐9.92) IQ: mean 110.7 (range not stated) MPH‐naive: not stated Ethnicity: white (93.5%), African American (6.5%) Country: USA Setting: hospital (Summer Treatment Program) Comorbidity: ODD (32%), CD (48%) Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 3 possible drug condition orders of 0.3 mg/kg and 0.6 mg/kg MPH and placebo Mean MPH dosage (SD): low 8.1 mg (range 5‐15); high 16.0 mg (range 10‐22.5) Administration schedule: twice/d morning and midday; conditions were changed daily over 6 weeks Duration of each medication condition: 2 weeks overall (individual treatment condition 1 day) Washout before trial initiation: not described Titration period: none Treatment compliance: not reported |
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Outcomes |
ADHD symptoms
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Notes | Sample calculation: no Ethics approval: not stated Key conclusion of trial authors
Inclusion of MPH responders only/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: not declared Email correspondence with trial author: June 2014. Emailed trial author to ask for additional information but have received no response |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Referred to as a randomised trial but sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Capsules were identically packaged |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Referred to as double‐blind but not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Appears to be 100% follow‐up Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | Protocol not identified |