Pelham 1989.
Study characteristics | ||
Methods | Cross‐over trial with 2 interventions:
Phases
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Participants | Number of participants screened: not stated Number of participants included: 24 (12 boys, 12 girls) Number followed up: not stated Number of withdrawals: not stated Diagnosis of ADHD: DSM‐III (combined (not stated), hyperactive‐impulsive (19/24), inattentive (2/24)) Age: mean not reported (range: boys 5 years 6 months‐11 years; girls 5 years 8 months‐11 years 3 months) IQ: boys 100.8 (SD 14.23), girls 104.0 (SD 16.52) MPH‐naive: not stated Ethnicity: not stated Country: USA Setting: outpatient clinic (summer treatment programme) Comorbidity: attention deficit disorder (1/24), CD (5/24), ODD (15/24), learning disability (6/25) Comedication: yes; other doses of stimulants reported but not on trial days Other sociodemographics: none 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 methylphenidate and placebo. "Each child received, in random order with condition varied daily, placebo twice a day and 0.3 mg MPH/kg twice a day." Mean MPH dosage: boys 9.8 mg (range 5.3‐16.9), girls 9.5 mg (range 5.2‐13.1) Administration schedule: twice daily at breakfast and at lunchtime Duration of each medication condition: not stated Washout before trial initiation: not stated Medication‐free period between interventions: no Titration period: none Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
General behaviour
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Notes | Sample calculation: no
Ethics approval: not stated Comment from trial authors
Key conclusions of trial authors
Comments from review authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: not stated Any withdrawals due to AEs: not stated Funding source: not declared Email correspondence with trial authors: October 2014. We received no supplemental information/data from trial authors. We asked authors whether this article was part of the Johnston 1988 trial but received no response, so we extracted the data as from 2 separate studies |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Each child received, in random order with condition varied daily, placebo and MPH |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Active medication and placebo were disguised in gelatin capsules and were pre‐packaged in individual, dated envelopes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated Selection bias (e.g. titration after randomisation → exclusion): unclear |
Selective reporting (reporting bias) | Unclear risk | No protocol found |