Therapeutic body wraps (TBW) for treatment of severe injurious behaviour in children with autism spectrum disorder (ASD): A 3-month randomized controlled feasibility study

Introduction: The use of therapeutic body wraps (TBW) has been reported in small series or case reports, but has become controversial. Objectives: This is a feasibility, multicentre, randomized, controlled, open-label trial with blinded outcome assessment (PROBE design). Setting: Children with autism and severe-injurious behaviours (SIB) were enrolled from 13 specialized clinics. Interventions: Dry-sheet TBW (DRY group) vs. wet-sheet TBW (WET group). Primary outcome measures: 3-month change in the Aberrant Behaviour Checklist irritability score (ABC-irritability) within per-protocol (PP) sample. Results: From January 2008 to January 2015, we recruited 48 children (age range: 5.9 to 9.9 years, 78.1% male). Seven patients (4 in the DRY group, 3 in the WET group) were dropped from the study early and were excluded from PP analysis. At endpoint, ABC-irritability significantly improved in both groups (means (standard deviation) = -11.15 (8.05) in the DRY group and -10.57 (9.29) in the WET group), as did the other ABC scores and the Children Autism Rating scale score. However, there was no significant difference between groups. All but 5 patients were rated as much or very much improved. A repeated-measures analysis confirmed the significant improvement in ABC-irritability scores according to time (p