Griffith 2012.
Methods |
Design: Randomised controlled trial
Unit of randomisation: Parent/child dyads
Follow‐up: 6 months Study dates: October 2007 to September 2010 |
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Participants |
Participants: Parents (87 mothers, 2 fathers) living in a designated Flying Start area (low socioeconomic area) Mean age of parents: 28.97 (SD 6.72; range: NR) years; intervention group: 28.6 (SD 7.0; range: NR) years, control group: 29.8 (SD 6.1; range: NR) years Age of child: 21.2 (SD 6.3, range 12 to 36) months; 37 girls and 52 boys Ethnicity: Not reported Number randomised: 89 (intervention 60; control 29) Country & setting: UK (Wales); multi‐site; recruited from Flying Start centres; delivery of intervention not reported Eligibility criteria: Child aged 12 to 36 months; parent and child must live within a designated Flying Start area in Wales; and families not to have been on an Incredible Years parenting programme in the past |
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Interventions |
Two conditions: Group parent training (Incredible Years Toddler parenting programme); wait‐list control
Duration of intervention: 12 (2.5 hours) sessions over 12 weeks Therapist training: Trained group leaders with mentor’s supervision |
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Outcomes |
Secondary outcomes: Parent‐child interaction as measured by the Dyadic Parent‐Child Interaction Scale, reported by observing researcher Timing of outcomes: Outcomes reported for 6 months follow‐up Primary outcomes/adverse events: No other outcomes relevant to this review specified |
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Notes |
Level of prevention: Primary Funding: the Welsh Assembly Government, Welsh Language Board, and Incredible Years Cymru |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study reported that participants were randomised using a "remote dynamic randomisation service provided by an independent trials unit" |
Allocation concealment (selection bias) | Low risk | The study reported that participants were randomised using a "remote dynamic randomisation service provided by an independent trials unit" |
Blinding of participants and personnel (performance bias) All outcomes | High risk |
Participants: It would not have been possible to fully blind participants in this type of study (there is an obvious difference between receiving group training and being placed on a 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 meant that personnel delivering the intervention were aware which groups had been assigned to the different study conditions |
Blinding of outcome assessment (detection bias) Independent observer reported outcomes | Low risk | The investigators reported that observers were blinded to the participants' experimental condition at baseline and follow‐up |
Blinding of outcome assessment (detection bias) Parent reported outcomes | Low risk | There were no parent‐reported outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 100% of participants completed the Schedule of Growing Skills assessment at follow‐up. 44/60 (73%) of the intervention group and 23/29 (79%) of the control group completed the Dyadic Parent‐Child Interaction Scale at follow‐up |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes, including those that were prespecified |
Other bias | Low risk | The study appeared to be free of other sources of bias |