Kaiser 2013.
Methods | Design: RCT | |
Participants |
Location: Tenessesse, USA Setting: 'clinic' location not specified, home sessions in participants' homes Child participants Sample size: 77 children with intellectual disability, 18 of whom had Down syndrome (intervention: 8, control: 10) Mean age: not reported (range 30‐54 months) IQ: intervention: mean 67 (SD 8.35), control: mean 68.5 (SD 7.65) Inclusion criteria
Comorbid conditions: none reported Number of children per family: not reported Parent participants Sample size: 18 parents (1 father (in the intervention group), 17 mothers) Mean age: intervention: 42.3 years, control: 39.8 years, range 30‐50 years across both groups Education: 3 parents had a master's degree, 8 a a bachelor's degree, 1 up to 3‐years of college, 2 up to 2‐years of college, 3 a high‐school level education, and 1 did not specify. Marital status: not reported Occupation: 9 participants were homemakers, with 8 (including the 1 father) being employed on a part‐ or full‐time basis, and 1 person did not specify Socioeconomic status: not reported, but see 'education' and 'occupation' directly above |
|
Interventions | The 18 participants were randomly assigned to 1 of 2 groups:
Most children in the intervention and control groups continued to receive regular community‐based speech‐language therapy during the study, as well as other special education services. |
|
Outcomes | The measures listed below were used to measure the outcomes immediately postintervention, 6 months postintervention and 1 month postintervention.
The study measured adherence to the intervention by the clinician, although parental dosage (intervention fidelity) was not reported. |
|
Notes |
Study start and end dates: not reported Funding source: this study was supported, in part, by the National Institute of Child Health and Human Development (grant HD45745) and by the Department of Education (grant H325D070075). Conflicts of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: children were randomly assigned to 1 of 2 experimental conditions using an automated, randomisation computer programme after the child qualified for the study. |
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: administration and scoring of norm‐referenced assessments were completed by staff members who were not blind to the experimental condition. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: although there were missing data, the reasons were unlikely to be related to the true outcome, and they were balanced across groups. |
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 |