Tannock 2018.
Study characteristics | ||
Methods | A 10‐week to 4 months parallel‐trial with 2 arms, which were further parted into 3 trial arms of different reading therapy:
Phases: 2 phases (open‐label titration and double‐blind intervention) |
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Participants | Number of participants screened: 221 Number of participants included: 65 (49 boys, 16 girls) Number of participants followed‐up: 49 (15 teacher ratings and 1 parent rating not completed) Number of withdrawals: 16 (15 teacher ratings and 1 parent rating not completed) 13 participants changed their allocated intervention (8 from MPH group, 5 from placebo group) Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: mean 8.5 years (SD 1.4, range 7‐11) IQ: 91.5 (SD 10.6) MPH‐naive: not stated Ethnicity: white (90%), African‐American (4%), Hispanic (1%), and Asian (5%) Country: Canada Setting: classroom laboratory in a clinical setting Comorbidity: all participants had a reading disorder. 29.3% had ODD 8.6% had CD Comedication: not stated Additional sociodemographics: socioeconomic status: 6.4 (SD 1.7) Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to receive either MPH at optimal dosage or placebo twice/d, while also receiving one of 3 reading interventions. Number randomised to each group: 39 to MPH, 26 to placebo. 13 participants changed their allocated intervention (8 from MPH group, 5 from placebo group) Mean medication dosage: not stated. Maximum oral dose of 0.7 mg/kg twice/d or 20 mg twice/d Administration schedule: twice/d, in the morning and before lunch Duration of each medication: 12‐13 weeks or 4‐5 months of MPH or placebo Washout before trial initiation: no information Titration period: 2‐3 week titration phase in which the dose of MPH or placebo was increased in 5 mg steps. Identical, scored, 10 mg pills of MPH and placebo were used Treatment compliance: research staff recorded the number of pills returned at trial completion (average of about 90%). |
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Outcomes |
ADHD symptoms
Serious AEs
General behaviour
Non‐serious AEs
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Notes | Sample calculation: no Ethics approval: no Comments from trial authors
Key conclusion of trial authors
Comments from review authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH: yes Any withdrawals due to AEs: not stated Funding source: an operating grant from the Canadian Institutes of Health Research (Grant #MT 13366), and by the donation of placebo medication from Novartis Pharmaceuticals. Email correspondence with the trial authors: September 2021. We sought supplemental information regarding details of the medical intervention through personal email correspondence with the authors in September 2021. Unfortunately the data are no longer available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | 20% of parents (n = 13) requested a change in their child’s assigned medication condition (8 from placebo to MPH; 5 from MPH to placebo) |
Allocation concealment (selection bias) | Low risk | Parents were then provided with a 4‐month supply of pills, each month packaged separately. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The MPH and placebo pills were identical in color, shape and size and were administered in a double‐blind manner twice daily (once in the morning before school and once at lunch)" Comment: 1 participant was unblinded during requested change of medication assignment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "We analysed behavioral data when both parent and teacher reports were present to ensure that results from these 2 sources could be compared" |
Incomplete outcome data (attrition bias) All outcomes | High risk | "Within the initial 2‐week dose‐adjustment phase and prior to starting the academic programs, 20% of parents (n= 13) requested a change in their child’s assigned medication condition (8 from placebo to MPH; 5 from MPH to placebo)." Comment: an ITT analysis as well as an as‐treated analysis was made Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): there was a titration phase after randomisation |
Selective reporting (reporting bias) | Unclear risk | No trial protocol identified |