Johnston 1988.
Study characteristics | ||
Methods | 2‐week cross‐over trial with 3 interventions:
Phases: to define rebound effects in 21 boys 4‐10 years of age, with a DSM‐III diagnosis of ADD and treated with MPH some days, and placebo other days |
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Participants | Number of participants screened: not stated Number of participants included: 21 Number of participants followed up: 21 (21 boys, 0 girls) Number of withdrawals: 0 Diagnosis of ADD: DSM‐III‐R (subtype not stated) Age: mean 7 years 7 months (range 4‐10 years) IQ: mean 101 (range 79‐120) MPH‐naive: not stated Ethnicity: not stated Country: USA Setting: outpatient clinic (summer treatment programme) Comorbidity: CD (n = 2), ODD (n = 17), learning disability (n = 9) Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to different drug condition orders of: 0.3 mg/kg MPH, 0.6 mg/kg MPH, 20 mg ER‐MPH, or placebo. Number randomised to each group: 0.3 mg/kg MPH twice daily: 21, 0.6 mg/kg MPH twice daily: 16 of the same 21 participants who received 0.3 mg/kg MPH, 20 mg ER‐MPH: 8, placebo, not stated. Within‐participant random sequence, condition varied daily Mean MPH dosage: not stated Administration schedule: twice daily, at breakfast and just before lunch Duration of intervention: 2 weeks. Note: it is not clear for how many days each boy received either of the MPH doses or placebo Washout before trial initiation: not stated Medication‐free period between interventions: not stated Titration period: not stated Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
Non‐serious AEs
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Notes | Sample calculation: none Ethics approval: no information Comment 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: no Funding source: not declared Email correspondence with trial authors: emailed trial authors to request additional information. Also asked whether this trial includes the Pelham 1989 reference. No answer from trial author, so we extracted data as from 2 different studies |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Order of drug condition for each child was randomly assigned over days |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Child, parent, teacher and programme counsellors were blinded to the condition. Active medication and placebo were disguised in gelatin capsules and pre‐packaged in individually 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 of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Unclear risk | No protocol available |