Ramtvedt 2013.
Methods | Multi‐center, randomized, placebo‐controlled, cross‐over trial Country: Norway Number of study sites: 4 Statistical methods: unclear | |
Participants | Sample size: 36* children/adolescents with an ADHD diagnosis according to DMS‐IV‐TR criteria Dropouts: 0 Psychiatric comorbid disorders: oppositional defiant disorder, anxiety/depression, learning disability Age range: 9 years to 14 years Mean age (SD): 11.4 (1.4) years Sex: 29 (81%) males ADHD subtype: 10 (28%) inattentive; 1 (3%) hyperactive ‐ impulsive; 25 (69%) combined | |
Interventions |
Three interventions (all 36 children/adolescents participated in each of the three interventions):
Duration: 42 days (3 x 14‐day treatment periods) |
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Outcomes |
Relevant outcomes:
Other outcomes:
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Notes |
ClinicalTrials.gov identifier: NCT01220440
Authors' affiliation: university and hospital
Study funding: public funds
Outcomes were presented across two publications *Data only provided on those children/adolescents who completed the trial; no information provided regarding number of children/adolescents randomized **Data is presented as an aggregate score of parent and teacher ratings and therefore could not be incorporated into the meta‐analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Primary analysis only included a subset of completers without any reason provided. No information on non‐completers provided |
Selective reporting (reporting bias) | High risk | Although the registered protocol stated that they would collect adverse events using the Side‐Effects Rating Scale, this was not reported in the published manuscript |
Other bias | Unclear risk | No information on the validity of the primary outcome measure provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Interventions and placebo were not identical |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessment not described |