Bradley 2003.
Methods | Parallel randomised controlled trial. | |
Participants |
Participants: parents of preschoolers with behavioural problems, recruited through advertisements placed in community locations. Sex: 184 mothers; 14 fathers. Age of parents: mean 35.20 years (SD 5.51) intervention; mean 35.88 years (SD 5.73) control. Unit of allocation: individual participant. Number randomised: 198 (89 intervention; 109 control). Number used in analysis: number available for analysis n=174 (81 intervention; 93 control)*. Country & setting: Canada; multi‐site (number unclear); recruited from community settings; intervention delivered in the community. Inclusion criteria: parents experiencing problems managing the behaviour of their 3 or 4 year old children. Exclusion criteria: not stated. Ethnicity: not stated. Baseline characteristics: described as largely middle‐class parents; >80% had post‐secondary education; significantly more boys (121) than girls (77); no significant differences between experimental and control groups on age of parents, age of child, or intactness of family. |
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Interventions | Two conditions: Psychoeducational programme with videotape modelling (behavioural parenting programme); wait‐list control. Duration of intervention: 7 weeks. Length of follow‐up: 12 months. |
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Outcomes | Depressive symptoms (Brief Symptom Inventory)*. Stress (Brief Symptom Inventory)*. |
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Notes | *Insufficient data to calculate effect sizes. Clarification was requested from the trial investigators but no further information was available at the time this review was prepared. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information reported insufficient for a judgement to be made. We requested clarification from the trial investigators, but no further information was available at the time this review was prepared. |
Allocation concealment (selection bias) | Unclear risk | Information reported insufficient for a judgement to be made. We requested clarification from the trial investigators, but no further information was available at the time this review was prepared. |
Blinding (performance bias and detection bias) Participants | High risk | Review authors judged that it would not be possible to fully blind participants in this type of study, and 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) Personnel | Unclear risk | Information reported insufficient for a judgement to be made. We requested clarification from the trial investigators, but no further information was available at the time this review was prepared. |
Blinding (performance bias and detection bias) Outcome assessors | Unclear risk | Information reported insufficient for a judgement to be made. We requested clarification from the trial investigators, but no further information was available at the time this review was prepared. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data for 8/89 (9%) missing from the intervention condition, and for 16/89 (15%) from the control condition. Reasons for dropout not given. Overall attrition was 11.8% at post‐intervention. Review authors considered the numbers of and reasons for missing data reasonably likely to be balanced across the treatment conditions. |
Selective reporting (reporting bias) | High risk | Investigators do not report endpoint / follow‐up data for depressive symptoms from the BSI subscale outcomes. Clarification has been requested, but the trial investigators (email from SJ Bradley to CB on 07/07/10) states that they "are unable to find the data". |
Other bias | Low risk | The study appeared to be free of other sources of bias. |