Evidence map›Paper›PMID 29958284›Full record

Trial reportPloS one2018

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

Pierre Delion, Julien Labreuche, Dominique Deplanque, David Cohen, Alain Duhamel, Céline Lallié, Maud Ravary, Jean-Louis Goeb, François Medjkane, Jean Xavier and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03164746 (Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03164746 nacompletednot on this map

Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.

TypeinterventionalSponsorUniversity Hospital, LilleRan2007 to 2014Enrolled48ConditionsAutism Spectrum DisorderArmsDry sheet Therapeutic body wraps, WET sheet Therapeutic body wraps
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 23 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Pierre DelionDépartement de Psychiatrie de l'Enfant et de l'Adolescent, Centre Hospitalier Universitaire de Lille, Lille, France.ORCID 0000-0001-8265-6756
Julien LabreucheUniversité de Lille, Centre Hospitalier Universitaire de Lille, Equipe d'Accueil A2694-Santé publique: épidémiologie et qualité des soins, Lille, France.
Dominique DeplanqueUniversité de Lille, Inserm, Centre Hospitalier Universitaire de Lille, CIC1403-Centre d'investigation clinique, Lille, France.
David CohenDépartement de Psychiatrie de l'Enfant et de l'Adolescent, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France.
Alain DuhamelUniversité de Lille, Centre Hospitalier Universitaire de Lille, Equipe d'Accueil A2694-Santé publique: épidémiologie et qualité des soins, Lille, France.
Céline LalliéDépartement de Psychiatrie de l'Enfant et de l'Adolescent, Centre Hospitalier Universitaire de Lille, Lille, France.
Maud RavaryDépartement de Psychiatrie de l'Enfant et de l'Adolescent, Centre Hospitalier Universitaire de Lille, Lille, France.
Jean-Louis GoebPôle 59i03, Département de Psychiatrie de l'Enfant et de l'Adolescent, Etablissement Public de Santé Mentale Lille-Métropole, Armentières, France.
François MedjkaneDépartement de Psychiatrie de l'Enfant et de l'Adolescent, Centre Hospitalier Universitaire de Lille, Lille, France.
Jean XavierDépartement de Psychiatrie de l'Enfant et de l'Adolescent, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France.
Therapeutic Body Wrap Study group
Centre Hospitalier Universitaire de Lille · FRCentre National de la Recherche Scientifique · FRUniversité de Lille · FREtablissements de Santé Mentale · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe use of therapeutic body wraps (TBW) has been reported in small series or case reports, but has become controversial.

objectivesThis is a feasibility, multicentre, randomized, controlled, open-label trial with blinded outcome assessment (PROBE design).

settingChildren with autism and severe-injurious behaviours (SIB) were enrolled from 13 specialized clinics.

interventionsDry-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.

resultsFrom 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).

conclusionsWe 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.

trial registrationClinicalTrials.gov NCT03164746.

Indexed as

Attention Deficit and Disruptive Behavior DisordersAutistic DisorderClothingChildChild, PreschoolFemaleHumansMaleTime Factors

Identifiers

PMID29958284
PMCPMC6025870
OpenAlexW2810360929

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.