Pliszka 2000.
Methods | Single‐center, randomized, double‐blind, placebo‐controlled, parallel‐group trial
Country: United States Number of study sites: 1 Statistical methods: modified ITT (last observation carried forward) |
|
Participants | Sample size: 59* children/adolescents with an ADHD diagnosis according to the Diagnostic Interview Schedule for Children Dropouts: 5 Psychiatric comorbid disorders: oppositional defiant disorder, conduct disorder, anxiety Age range: 6 years to 10 years Mean age (SD): 8.2 (1.6) years Sex: NR ADHD subtype: NR | |
Interventions |
Three interventions (58 children/adolescents participated in one of three interventions):
Duration: 21 days |
|
Outcomes |
Relevant outcomes:
Other outcomes:
|
|
Notes |
ClinicalTrials.gov identifier: not available Author's affiliation: university and pharmaceutical industry Study funding: pharmaceutical industry *1 participant dropped out before the end of the study, and was not accounted for in the participant characteristic description (data only provided on 58 participants) |
|
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 | Low attrition (10%), and reasons provided. All randomized children/adolescents included in primary analysis |
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 | Low risk | Intervention and placebo are described as identical |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessment not described |