Donnelly 1989.
Methods | Single‐center, randomized, double‐blind, placebo‐controlled, cross‐over trial
Country: United States Number of study sites: 1 Statistical methods: ITT |
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Participants | Sample size: 20 children/adolescents with an ADHD diagnosis according to DSM‐III criteria Dropouts: NR Psychiatric comorbid conditions: oppositional defiant disorder, conduct disorder, mental learning disorder, language disorder Age range: NR Mean age (SD): 8 (2) years Sex: 20 (100%) males ADHD subtype: NR | |
Interventions |
Three interventions (all 20 children/adolescents participated in each of the three interventions):
Duration: 63 days (3 x 21‐day treatment periods) |
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Outcomes |
Relevant outcomes:
Other outcomes:
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Notes |
ClinicalTrials identifier: not available Authors' affiliation: university and National Institute of Mental Health Study funding: NR Donnelly 1986 is a pilot study of Donnelly 1989 and therefore have overlapping data *Unpublished data on the Clinical Global Impression scale sought on three separate occasions but not obtained |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 sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All recruited children/adolescents included in analyses. Only one dropout, with reasons provided |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available and the possibility of reporting bias could not be assessed |
Other bias | Unclear risk | No information on the validity of the primary outcome measure provided |
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 |