TY - JOUR
T1 - Therapeutic body wraps (TBW) for treatment of severe injurious behaviour in children with autism spectrum disorder (ASD)
T2 - A 3-month randomized controlled feasibility study
AU - Delion, Pierre
AU - Labreuche, Julien
AU - Deplanque, Dominique
AU - Cohen, David
AU - Duhamel, Alain
AU - Lallié, Céline
AU - Ravary, Maud
AU - Goeb, Jean Louis
AU - Medjkane, François
AU - Xavier, Jean
N1 - Publisher Copyright:
© 2018 Delion et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2018/6
Y1 - 2018/6
N2 - 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 < .0001), with no significant difference between the two groups (group effect: p = .55; interaction time x group: p = .27). Pooling both groups together, the mean 3-month change from baseline in ABC-irritability score was -10.90 (effect size = 1.59, p < .0001). Conclusions We found that feasibility was overall satisfactory with a slow recruitment rate and a rather good attrition rate. TBW was a safe complementary therapy in this population. There was no difference between wet and dry TBW at 3 months, and ABC-irritability significantly decreased with both wet and dry sheet TBW. To assess whether TBW may constitute an alternative to medication or behavioural intervention for treating SIB in ASD patients, a larger randomized comparative trial (e.g. TBW vs. antipsychotics) is warranted.
AB - 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 < .0001), with no significant difference between the two groups (group effect: p = .55; interaction time x group: p = .27). Pooling both groups together, the mean 3-month change from baseline in ABC-irritability score was -10.90 (effect size = 1.59, p < .0001). Conclusions We found that feasibility was overall satisfactory with a slow recruitment rate and a rather good attrition rate. TBW was a safe complementary therapy in this population. There was no difference between wet and dry TBW at 3 months, and ABC-irritability significantly decreased with both wet and dry sheet TBW. To assess whether TBW may constitute an alternative to medication or behavioural intervention for treating SIB in ASD patients, a larger randomized comparative trial (e.g. TBW vs. antipsychotics) is warranted.
UR - http://www.scopus.com/inward/record.url?scp=85049256375&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0198726
DO - 10.1371/journal.pone.0198726
M3 - Article
C2 - 29958284
AN - SCOPUS:85049256375
SN - 1932-6203
VL - 13
JO - PLoS ONE
JF - PLoS ONE
IS - 6
M1 - e0198726
ER -