Whalen 1990.
Study characteristics | ||
Methods | 2‐day cross‐over trial with 2 interventions
In a connected trial 25 children were randomised to the same interventions. The outcome of this trial included the social judgement processes during the different drug conditions. Outcomes from the trial included in this review were reported in this connected trial. |
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Participants | Number of participants screened: unknown Number of participants included: 24 Number of participants followed up: 24 (22 boys, 2 girls) Number of withdrawals: 0 ADHD diagnosis: trial 1 DSM‐III‐R Age: trial one mean 9 years 8 months (range 6.4‐13.2 years) IQ: no mental disability MPH‐naive: 0% Ethnicity: white (92%), African American (4%), Hispanic (4%) Country: USA Setting: outpatient clinic (Summer Treatment Program) Comorbidity: not stated Comedication: not stated Other sociodemographics: all were from middle‐ or low middle‐income backgrounds Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of the possible drug condition orders of 0.3 mg/kg MPH or placebo. Mean MPH dosage: 8.75 mg Administration schedule: twice/d, morning and lunchtime Duration of each medication condition: 1 day Washout before trial initiation: unknown Medication‐free period between interventions: medication and placebo were given on 2 consecutive days Titration period: none Treatment compliance: good (2 staff dispensed the medication for ingestion) |
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Outcomes |
General behaviour
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Notes | Sample calculation: no Ethics approval: no information Key conclusions of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes; only participants taking maintenance dosage of MPH or well titrated Any withdrawals due to AEs: no Funding source: not stated Email correspondence with trial authors: January 2014. No supplemental information has been received |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both active medication and placebo were placed in opaque gelatin capsules. 2 staff, blinded to medication status, dispensed medication |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessments were made by independent healthy controls through video tapes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Low risk | No indication of selective reporting |