Hutchings 2007.
Methods |
Design: Parallel randomised controlled trial
Unit of randomisation: Parent‐child dyads
Follow‐up: 6 months Study dates: 2002 to 2006 |
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Participants |
Participants: Socially disadvantaged parents (gender not reported) with children scoring above the clinical cut‐off on either the Eyberg Child Behaviour Inventory ‐ problem or intensity scale Mean age of parents: Not reported Mean age of child: Entire sample range 3 to 4 years (mean, SD: NR), intervention mean 46.2 (SD 4.2; range: NR) months, control 46.4 (SD 6.6; range: NR) months; 70 boys and 63 girls Ethnicity: Not reported Number randomised: 153 (intervention 104; control 49) Country & setting: UK (Wales); multi‐site; recruited from community settings; intervention delivered in the community Eligibility criteria: Families living within a designated Sure Start (socially disadvantaged, predominantly low‐income) area with a child aged three or four years scoring above the clinical cut‐off on either the problem or intensity scale of the Eyberg Child Behaviour Inventory |
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Interventions |
Two conditions: Group‐based parent training (Incredible Years BASIC parenting programme); wait‐list control
Duration of intervention: 12 weeks Therapist training: Trained leaders with supervision |
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Outcomes |
Externalising problems: Eyberg Child Behaviour Inventory ‐ intensity, parent‐reported (problem and conduct subscale data not added) Externalising problems subscale ‐ hyperactivity/inattention: Strengths and Difficulties Questionnaire ‐ hyperactivity, parent‐reported (total child deviance and conduct subscale data not added) Secondary outcomes: Parent‐child interaction as measured by Dyadic Parent‐Child Interaction Coding System ‐ child deviance, observer‐reported Data for Conners Abbreviated Parent/Teacher Rating Scale, parent‐report and Kendall Self Control Rating Scale, parent‐rated were not added to the meta‐analyses Timing of outcomes: Outcomes reported for 6 months follow‐up Adverse events: None specified |
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Notes | We are grateful to the study authors for replying to our request for additional data Level of prevention: Secondary or tertiary Funding: The Health Foundation (UK) (ref: 1583/1566) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were block randomised by area using a random number generator, after stratification by gender and age |
Allocation concealment (selection bias) | Low risk | One of the authors blindly allocated participants, further information from the study investigators confirmed this and states "...researchers kept blind as to allocation" (Hutchings 2007) |
Blinding of participants and personnel (performance bias) All outcomes | High risk |
Participants: It would not be possible to fully blind participants in this type of study (there is an obvious difference between receiving group training and waiting list. No indication of any specific additional measures taken to reduce the risk of bias that might result from differential behaviours by participants were found Personnel: The design of the study means personnel delivering the intervention would be aware which groups had been assigned to the different study conditions |
Blinding of outcome assessment (detection bias) Independent observer reported outcomes | Low risk | Study investigators reported "researchers blind to allocation carried out the interviews and observations" |
Blinding of outcome assessment (detection bias) Parent reported outcomes | High risk | Outcome assessments by parents were not blinded as parents were aware of the intervention condition |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 18 out of 104 participants in the intervention group and 2 out of 49 left the study early; reasons for leaving early were reported. An intention‐to‐treat analysis was used |
Selective reporting (reporting bias) | Low risk | The published report includes all expected outcomes, including those that were prespecified |
Other bias | High risk | The principal investigator reports a conflict of interest which could potentially lead to pro‐intervention bias in the language of the paper: “Competing interests: JH is paid by Incredible Years for running occasional training courses in the delivery of the parent programme . . ." (p 7600) |