Conners 1971.
Methods | Design: placebo‐controlled parallel trial | |
Participants |
Participants: boys at a residential facility for delinquent offenders Sex: male only Age: mean 12.0 years; range 9 to 14 years Unit of allocation: individual participant Number randomised: 43 (30 to antiepileptic or placebo arms) Number completing: no attrition reported Setting: inpatient (residential); USA (Maryland) Inclusion criteria: not formally reported; participants described as “young juvenile offenders . . . . selected from 52 cases nominated by the training school staff as being the most aggressive or disturbed in their cottages” Exclusion criteria: any current medication; previous psychotropic medication; abnormal white blood cell count Ethnicity: not reported Baseline characteristics: not reported |
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Interventions | Three conditions: diphenylhydantoin sodium / methylphenidate / placebo (note that methylphenidate is not an antiepileptic drug)
Duration of intervention: 2 weeks Length of follow up: participants were not followed up beyond the end of the intervention period Dose adjustment: no information reported |
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Outcomes |
Primary outcomes None Secondary outcomes Impulsivity: Porteus Maze scores (see note 1) Anger: Rosenweig Picture Frustration Test categories (negative responses indicated ‘anger, aggressiveness or vengeful feeling’) Other outcomes Mean symptom scores (care staff/teachers ratings) Behavioural incidents (care staff ratings) |
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Notes | 1. Trial investigators report that the Porteus Maze test is “presumed to measure impulsiveness and ability to plan and organize response” (page 157), but later raise concerns about the degree to which scores on this test are a good measure of impulsivity. The Porteus Maze test was administered on last day of treatment one hour after medication given. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Investigators report that “boys within each cottage were randomly assigned to three treatment groups“ (p.156, col 2). No further details given. Due to age of study, unable to contact trial investigators for more information. |
Allocation concealment? | Unclear risk | No details reported. Due to age of study, unable to contact trial investigators for more information. |
Blinding? of participants | Low risk | Investigators report that medication “was supplied to cottage parents in identical matched capsules, with the staff and investigators blind to the assignment condition” (p.156, col. 2). Review authors judge that blinding of participants was adequate and that it was unlikely that this blinding could have been broken. |
Blinding? of personnel | Low risk | Investigators report that medication “was supplied to cottage parents in identical matched capsules, with the staff and investigators blind to the assignment condition” (p.156, col. 2). Review authors judge that blinding of personnel was adequate and that it was unlikely that this blinding could have been broken. |
Blinding? of outcome assessors | Low risk | Investigators report that Rosenweig Pictures were “scored blindly . . . by two independent raters” (p.157, col. 1). Review authors judge that blinding of outcome assessors was adequate and that it was unlikely that this blinding could have been broken. |
Incomplete outcome data addressed? All outcomes | Low risk | No attrition or exclusions were reported; no missing outcome data. In this review, data from 30 participants were included in the analysis. |
Free of selective reporting? | Low risk | Study protocol is not available but it seems clear that the published report includes all expected outcomes, including those that were pre‐specified |
Free of other bias? | Low risk | The study appeared to be free of other sources of bias |