Zollweg 1997.
Methods | Randomised controlled trial. Randomised using a random numbers table Blinding: investigators and outcomes assessors blinded Duration: 9 months | |
Participants | Diagnosis: cognitive impairment including autism spectrum disorder. Age: 7‐24 years n=30 | |
Interventions | 1. AIT 2 30 min sessions for 10 consecutive days 2. Control: as above but music unmodified |
|
Outcomes | Standardised tests of behaviour, sound sensitivity, measurement of pure tone thresholds | |
Notes | 28 analysed for ABC at 9mths 22 analysed for loudness discomfort 14 analysed for pure tone thresholds | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table |
Allocation concealment (selection bias) | High risk | Inadequate, following communication with study author (Zollweg 2002 (pers comm)) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 2 patients lost to follow‐up (1 from each group) prior to completion of study. There were fewer participants for audiological and sound sensitivity data due to illness or poor cooperation |
Selective reporting (reporting bias) | Low risk | The outcomes listed in the methods are reported in the results |
Other bias | Unclear risk | Treatment group included 9 cognitively impaired and 6 autistic patients, control group included 12 cognitively impaired and 3 autistic patients. Correspondence with author confirmed that all participants had been diagnosed with autism |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Investigators blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes assessors blinded |