Firestone 1981.
Study characteristics | ||
Methods | 3‐month, randomised, double‐blind, placebo‐controlled, parallel trial, wherein participants were randomly assigned to 3 arms:
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Participants | Number of participants screened: 91 Number of participants included: not stated (includes boys and girls) Number of participants followed up: intervention 18, control 13 Number of withdrawals: not stated Diagnosis of ADHD: DSM‐III Age: mean 7.32 years (range 5‐9) MPH‐naive: not stated Ethnicity: not stated Country: not stated Setting: outpatient clinic Comorbidity: not stated Comedication: not stated IQ: 116 Other sociodemographics: all children living at home with ≥ 1 parent. No significant differences in age and IQ between treatment groups. No data on remaining parameters Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to MPH + parent training (intervention group) or to placebo + parent training (control group). After the titration period MPH was given only on school days Average MPH dosage: 22 mg/d (range 10 mg/d‐30 mg/d) Titration period: first 3‐4 weeks: MPH was titrated (after randomisation), starting with 5 mg twice/d (morning, noon), 7 days a week Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
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Notes | Ethics approval: no information Key conclusions of trial authors
Comment from review 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: yes, 4 participants responded adversely and were dropped from the trial Funding source: Ministry of Health |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Children were randomly assigned; no description of how |
Allocation concealment (selection bias) | Unclear risk | No data |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Parents, teachers, therapists and those testing the children were unaware of medication conditions |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Parents, teachers, therapists and those testing the children were unaware of medication conditions |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No data Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): none |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |