Giblin 2011.
Methods | Single‐center, randomized, double‐blind, placebo‐controlled, parallel‐group trial
Country: United States Number of study sites: 1 Statistical methods: modified ITT (all randomized children/adolescents who had both a baseline and a post‐randomization primary outcome assessment) |
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Participants | Sample size: 24 children/adolescents with an ADHD diagnosis according to DSM‐IV‐TR criteria Dropouts: 0 Psychiatric comorbid conditions: NR Age range: 6 years to 12 years Mean age (SD): 9.65 (2.2) years Sex: 10 (42%) males ADHD subtype: NR | |
Interventions |
Four interventions (24 children/adolescents participated in one of four interventions):
Duration: 28 days |
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Outcomes |
Relevant outcomes:
Other outcomes:
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Notes |
ClinicalTrials.gov identifier: not available Authors' affiliation: private organization and pharmaceutical industry Study funding: pharmaceutical industry *Unpublished data sought on both outcome measures on three separate occasions but not obtained |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Incomplete outcome data not addressed; number of completers not reported |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available and the possibility of reporting bias could not be assessed |
Other bias | Low risk | Study appears to be free of other biases |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants and personnel not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessment not described |