Corbett 2008.
Methods | Randomised controlled trial (cross‐over) | |
Participants | Diagnosis: autistic disorder based on DSM‐IV criteria, Autism Diagnostic Observation Schedule‐Generic (ADOS‐G) and clinical judgement Age: 3‐7 years n=11 |
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Interventions | 1. Tomatis Method: filtered music, "Electronic Ear" headphone, auditory feedback, specially produced compact discs of Mozart and Gregorian chants 4 three‐week treatment blocks, total duration: 18 weeks 2. Placebo: commercially produced Mozart and Gregorian chant compact discs, no active microphone or "Electronic Ear", schedule as for treatment group |
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Outcomes | Standardised tests assessing core features of autism, cognitive ability and language | |
Notes | No loss to follow‐up | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generation table provided by a independent statistician (personal communication with study author) |
Allocation concealment (selection bias) | Low risk | Sequence table held in a sealed envelope in locked filing cabinet until study completion |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | The outcomes listed in the methods are reported in the results |
Other bias | High risk | The authors report that "although the participants were randomly assigned to the groups, the developmental level appeared to be different for each in that the placebo/treatment group was higher functioning than the treatment/placebo group." The study was a crossover design and it is unclear whether there was sufficient washout between each treatment period |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Parents blinded until conclusion of the study. Individuals administering the music were not blinded but were not affiliated with the M.I.N.D. institute (Corbett 2011) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | M.I.N.D. institute researchers remained blind until the conclusion of the study |