Pelham 2002.
Study characteristics | ||
Methods | Cross‐over trial with 2 interventions:
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Participants | Number of participants screened: not stated Number of participants included: 136 (all boys) Number of participants followed up: 136 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐III‐R (therefore no subtype) Age: mean 9.7 years (range 7.6‐12.7) IQ: mean 104.5 MPH‐naive: not stated Ethnicity: white (81%), African American (15%) Country: USA Setting: Summer Treatment Program Comorbidity: ODD (53%), CD (24%) Comedication: not stated Other sociodemographics: median family income: USD 25,000, (range USD 10,000 to > USD 100,000) Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 2 possible drug condition orders of 0.3 mg/kg MPH and placebo Mean MPH dosage: 10 mg (SD 2.7) Administration schedule: twice daily at 7:45 am and 11:45 am Duration of each medication condition programme: 12 days (order randomly assigned daily over 6 weeks, doses administered over week days, except on Fridays); follow‐up: 30 days Washout before trial initiation: 2 weeks medication‐free baseline in programme, unclear for follow‐up Titration period: none Treatment compliance: not reported |
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Outcomes |
ADHD symptoms
General behaviour
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Notes | Sample calculation: no Ethics approval: yes Comment from trial authors
Key conclusion of trial 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: NIMH (Grant MH48157) Email correspondence with trial authors: June 2014. Emailed trial authors to ask for additional information but have not received a reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Capsules were identical |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Raters were blinded to medication condition |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All of the outcomes used for this review are reported for 133 of the 136 boys. The reason for the missing data is not stated. Selection bias (e.g. titration after randomisation → exclusion): Unclear |
Selective reporting (reporting bias) | Unclear risk | Although measures were rated daily, how data were aggregated/reported as a single result per phase is not clear. |