Borcherding 1990.
Methods | Single‐center, randomized, double‐blind, placebo‐controlled, cross‐over trial Country: United States Number of study sites: 1 Statistical methods: ITT (all randomized children/adolescents are included in the analysis, with any missing data imputed with the group mean value) | |
Participants | Sample size: 46 children/adolescents with an ADHD diagnosis according to DSM‐III criteria Dropouts: NR Psychiatric comorbid conditions: oppositional defiant disorder, conduct disorder, reading developmental disorder, arithmetic disorder, dysthymic disorder Age range: 6 years to 12 years Mean age (SD): 8.6 (1.7) years Sex: 46 (100%) males ADHD subtype: NR | |
Interventions |
Three interventions (all 46 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.gov identifier: not available
Authors' affiliation: National Institute of Mental Health
Study funding: NR Outcomes were presented across four publications with varying sample sizes *Unpublished data on the ADHD symptoms as rated by the Conners' Teacher Rating Scale ‐ Short Form were sought on three separate occasions but were not obtained |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 | High risk | This study has four associated publications, and all reports have varying numbers of participants. Upon communication with the corresponding author of these reports, it was confirmed that the numbers of participants vary in the four publications due to missing data and dropouts. Reasons for missing data not 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 |