Karaaslan 2013a.
Methods | Design: RCT | |
Participants |
Location: Turkey Setting: participants were drawn from 2 special education rehabilitation centres Child participants Sample size: 15 children (intervention: 7, control: 8) with Down syndrome Mean age: intervention: 55.1 months, control: 44.1 months, range 2‐6 months across both groups IQ: the overall IQs of the children were not clear. Inclusion criteria: children had to be under 6 years of age, with a diagnosis of Down syndrome, and their mothers must not have been previously involved in a parenting intervention Comorbid conditions: not reported Number of children per family: not reported Parent participants Sample size: 15 mothers Mean age: intervention: 42.4 years, control: 42.4 years Education(mean level): intervention: 8.9 years, control: 9.6 years Marital status: all married Occupation: not reported Socioeconomic status: not reported but see 'education level' above |
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Interventions | The 15 participants were randomly assigned to 1 of 2 groups.
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Outcomes | The measures listed below were used to measure the outcomes, 2 months following the intervention.
The study measured adherence to the intervention by the clinician, although parental dosage (intervention fidelity) was not reported. |
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Notes |
Study start and end dates: not reported Funding source: not reported Conflicts of interest: not reported, although the 2nd author was one of the authors of the intervention programme |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: children were randomly assigned to the treatment or control group using a computer‐generated list of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Comment: did not report if this was conducted |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not possible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: 2 of the assessments used were totally or partially based on parent report, and parents were not blind to the group assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: seemed to be no missing outcome data |
Selective reporting (reporting bias) | Low risk | Comment: reported all pre‐specified outcomes |
Other bias | Low risk | Comment: appears to be free of other sources of bias |
EMT: enhanced milieu teaching; IPSyn: Index of Productivity of Syntax; MLU: mean length of utterances; NDW: number of different words; RCT: randomised controlled trial; SICD: sequenced inventory of communication development.