Solís‐Cámara 2004.
Methods |
Design: Parallel randomised controlled trial
Unit of randomisation: Mother/child dyads
Follow‐up: 6 months Study dates: No information provided |
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Participants |
Participants: Parents (30 mothers, 10 fathers) of children fulfilling criteria for behavioural difficulties Mean age of parents: 35.3 (SD 6.9; range: NR) years; Mean, SD, range for intervention and control and for mothers and fathers: NR Mean age of child: 3.7 (SD 0.8, range 3 to 5) years; 24 boys and 16 girls; Mean, SD, range for intervention and control: NR Ethnicity: Not reported Number randomised: 40 (intervention 20; control 20) Country & setting: Mexico; recruited from preschool settings Eligibility criteria: Not specified |
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Interventions | Two conditions: Group‐based parent training (research‐based standardised parenting programme); wait‐list control Duration of intervention: 8 (1.5 hour) sessions over 8 weeks Therapist training: Not reported | |
Outcomes |
Secondary outcomes: Social skills as measured by the Eyberg Child Behaviour Inventory ‐ social behaviour, parent‐reported (negative behaviour not added); parent‐child interaction as measured by a checklist of observations of interactions (IOI ‐ Informe de Observation de la Interaction, back‐translated and validated), observer‐rated Timing of outcomes: Outcomes reported for 6‐month follow‐up Primary outcomes/adverse events: No other outcomes relevant to this review specified |
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Notes |
Level of prevention: Secondary or tertiary Funding: No information provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study investigators reported "people were randomly assigned to two groups using a table of random numbers; subsequently with a toss of a coin it was decided which group was to receive the intervention or control (waiting list)" (p 203) |
Allocation concealment (selection bias) | Low risk | The study investigators reported "people were randomly assigned to two groups using a table of random numbers; subsequently with a toss of a coin it was decided which group was to receive the intervention or control (waiting list)" (p 203) |
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 wait 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 | Unclear risk | Information reported insufficiently for a judgement to be made |
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 | Unclear risk | There was no mention of incomplete outcome data. They stated that 50 children and parents were chosen and 10 were excluded before entering the study |
Selective reporting (reporting bias) | Unclear risk | It seems that all outcomes were reported, but not with sufficient information |
Other bias | Low risk | The study appeared to be free of other sources of bias |