Woodall 2007.
Study characteristics | ||
Methods | Design: parallel randomised controlled trial | |
Participants |
Participants: incarcerated drink‐driving offenders with AsPD sentenced to a Driving While Intoxicated (DWI) treatment programme Sex: (for AsPD subgroup) 45/52 (87%) males; 7/52 (13%) females Age: (for AsPD subgroup) mean = 26.5 years (SD = 7.9) Unit of allocation: individual participant Number randomised: 52 (n = 36 intervention group; n = 16 control group) Number completing: 52 (n = 36 intervention group; n = 16 control group) Setting: prison, single site, USA (New Mexico) Inclusion criteria: court‐defined first offenders sentenced to the Driving While Intoxicated (DWI) treatment programme whilst in prison; diagnosis of AsPD (DSM‐III‐R, Diagnostic Interview Schedule) Exclusion criteria: none reported Ethnicity: (for AsPD subgroup) 37/52 (71%) Native American; 12/52 (23%) Non‐Hispanic white; 3/52 (6%) Hispanic or other Baseline characteristics: 42/52 (89%) met DSM‐III‐R criteria for alcohol dependency using the Diagnostic Interview Schedule; mean DrinC score = 23.8 (SD 9.9); mean number of days drinking in past 30 days = 9.2 (SD 8.4) days; mean number of days in last 30 days when had drank and then driven = 3.9 (SD 5.3) days; mean number of drinks per drinking day = 5.9 (SD 5.1); mean number of days with 5 or more drinks = 5.9 (SD 6.9); mean number of days driving after 5 or more drinks = 2.9 (SD 4.3); Form 90 measures of drinking over past 90 days: total standard ethyl‐alcohol consumption (SEC) = 328.0 (SD 431.3), drinking days = 25.7 (SD 26.3), mean blood alcohol content (BAC) = 0.043 (SD 0.058) |
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Interventions | Two conditions: 'driving whilst intoxicated' programme (DWI) + incarceration; or incarceration only
Details of conditions:
Duration of intervention: 28 days Duration of trial: 25 months (1 month of intervention and 24 months of follow‐up) Length of follow‐up: 6, 12 and 24 months Dose adjustment: n/a |
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Outcomes |
Primary outcomes
Secondary outcomes
Other outcomes
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Notes |
Study funding: National Institute on Alcohol Abuse and Alcoholism Declaration of interests: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: No information provided. Insufficient reporting to permit judgement of Yes or No. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared. |
Allocation concealment (selection bias) | Unclear risk | Comment: No information provided. Insufficient reporting to permit judgement of Yes or No. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared. |
Blinding (performance bias and detection bias) of participants | Unclear risk | Comment: In a study such as this, full blinding is difficult to achieve because participants would be aware whether or not they were participating in a psychological intervention and may also be aware of the nature of this intervention. The review authors judged that it would thus not be possible to fully blind participants in this type of study. We found no indication of any specific additional measures taken to reduce the risk of bias that might result from differential behaviours by participants. |
Blinding (performance bias and detection bias) of personnel | Unclear risk | Comment: In a study such as this, full blinding is difficult to achieve because personnel would be aware whether or not they were participating in a psychological intervention and may also be aware of the nature of this intervention. The review authors judged that it would thus not be possible to fully blind personnel in this type of study. |
Blinding (performance bias and detection bias) of outcome assessors | Unclear risk | Comment: Insufficient information to allow a judgement to be made. Clarification about blinding of outcome assessors has been requested from the trial investigators, but no further information was available at the time this review was prepared. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: For the outcome of self‐reported drink‐driving behaviour, data missing for 6/36 (17%) of the intervention group and for 3/16 (19%) of control group. Although these numbers appear similar, reasons for this missing data were not provided. For the outcome of alcohol use, the amount of missing self‐report data was not reported but review authors judged it reasonable to assume that the above figures also applied to this as it was measured similarly. For the outcome of drink‐driving recidivism, it was unclear what numbers of missing data occurred in the AsPD subgroup, although for the entire sample missing data on this item was reported as 31/305 (10%). Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared. |
Selective reporting (reporting bias) | Low risk | Comment: Study protocol was not available but it seemed clear that the published report included all expected outcomes. No evidence of selective reporting. All prospectively stated outcomes were reported. |
Other bias | Unclear risk | Comment: In terms of baseline imbalance, the intervention group was significantly more likely to have histories of drinking and driving in comparison with the controls, although it was unclear if this applied to the AsPD subgroup. |