Edelson 1999.
| Methods | Randomised controlled trial. Randomisation based on telephone number Blinding: investigator not blinded, outcome assessors blinded. Duration: 3 months | |
| Participants | Diagnosis: autism Age: 4‐39 years n=18 | |
| Interventions | 1. AIT 2 30‐min sessions for 10 consecutive days 2. Control: as above, but music unmodified | |
| Outcomes | Standardised tests assessing behaviour, auditory problems, electrophysiological recordings (P300 ERP) | |
| Notes | Data from 1 control participant excluded due to no match in the AIT group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Randomisation based on telephone number |
| Allocation concealment (selection bias) | High risk | Inadequate, following communication with the author (Edelson 2002 (pers comm)) |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Nil loss to follow‐up but results for one patient in the control group were not used as analyses were based on matched pairs. Only 5 participants able to complete electrophysiological tasks and audiometric assessments due to poor language and attention skills |
| Selective reporting (reporting bias) | High risk | Total scores presented for Aberrant Behaviour Checklist only |
| Other bias | Unclear risk | "A comparison of the pre‐assessment total scores (reflecting the number of behavioural or auditory problems) was conducted for all three questionnaires and indicated no a priori significant differences between the experimnetal (AIT) and the placebo groups)" however no raw data is provided Partial funding support provided by the Nancy Lurie Marks Charitable Trust |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Investigator provided processed or unprocessed music to each participant but "did not interact with parents, guardians or participants after group assignment was determined". Parents and guardians unaware of the group to which participants were assigned |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Evaluators unaware of group assignment for participants |