Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism With Severe Injurious Behavior. (PACKING)

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

Severe injurious behaviors in children with autism spectrum disorder are challenging. First line treatment approaches include behavioral techniques but pharmacotherapy is frequently required despite frequent adverse effects in youths.

Therapeutic body wraps has been reported in small series or case reports, but has never been assessed in the context of a randomized controlled trial.

The present study is an exploratory, multicenter, randomized, controlled, open label with blinded outcome assessment (PROBE design) trial of the effect of wet versus dry therapeutic body wraps in children presenting with autism spectrum disorder and severe injurious behavior.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Dry sheet Therapeutic body wraps; Other: WET sheet Therapeutic body wraps

Detailed Description

Packing therapy has never been assessed, namely in children with severe injurious behavior and autism spectrum disorder.

The aim of the present study is to evaluate the beneficial effect of wet versus dry therapeutic body wraps through an exploratory randomized controlled open label blinded outcome assessment approach.

The primary objective is the comparison of change in ABC irritability scores from baseline to 3 months between the two groups. According to the potential recruitment, we plan to recruit 30 subjects in each group. This sample size could allow us to detect a minimum effect size of 0.74 between the 2 groups (considered large in literature) with a power of 80% (two-sided test and type I error of 5%).

As described elsewhere, wet or dry session will be organized through twice-a-week sessions for a 3-month duration.

Comparison in primary outcome (ABC irritability score) between the 2 groups will be performed using Analysis of Covariance (ANCOVA) adjusted for the baseline value. The standardized difference (effect size) will be computed taking into account the adjustment for baseline and its 95% confidence interval will be estimated using a bootstrap resampling. The validity of the ANCOVA model will be checked by examining the model residuals.

The same methodology will be used for the secondary outcomes.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Centre de Santé Mentale Angevin
  • Arras, France
    • Centre Hospitalier d'Arras
  • Aulnay-sous-Bois, France
    • Centre Hospitalier Robert Ballanger
  • Avignon, France
    • Centre Hospitalier Montfavet
  • Camiers, France
    • Institut Départemental Albert Calmette
  • Douai, France
    • Centre Hospitalier de Douai
  • Gennevilliers, France
    • Etablissement Public de Santé Roger Prévot
  • Lens, France
    • Centre Hospitalier de LENS
  • Lille, France
    • Hôpital Fontan, CHRU
  • Montigny-en-Ostrevent, France
    • Institut Médico-éducatif
  • Paris, France
    • Etablissement de Santé Maison Blanche
  • Paris, France
    • Groupe Hospitalier Pitier-Salpêtrière
  • Saint-Venant, France
    • Etablissement Public de Santé Mentale Val de Lys-Artois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• a current diagnosis of autism, Asperger syndrome, atypical autism according ICD-10 criteria confirmed by specialized clinical assessment;
• presenting severe behavioural disturbances such as hetero and self-injurious behaviours, automutilation, severe motor hyperactivity, severe stereotypies.
• having a systematically consultation by a neuro pediatric.

Exclusion Criteria:

• children with known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities.
• patients with stabilized seizure condition, antiepileptic medication should be stable for at least 4 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DRY group; Dry sheet therapeutic body wraps will be conducted through twice-a-week sessions for a 3-month duration. Sessions take place in the same quiet room and they usually last 45 minutes each up to 1 hour depending on the patient's response. During sessions, the patient wearied a bathing suit. Sessions were conducted under the supervision of an occupational therapist and involved at least two members of the patient's care team.	Other: Dry sheet Therapeutic body wraps; At the beginning of the session, the patient's consent to proceed was orally obtained, as no session was compulsory. The therapists checked behavioral manifestations of refusal. Then, the patient was first wrapped in Dry damp sheets (cold phase) and covered up with a rescue and a dry blanket. Afterward the body spontaneously warmed up (warm phase). The patient was then invited to freely express his feelings.
Experimental: WET Group; Wet sheet therapeutic body wraps will be conducted through twice-a-week sessions for a 3-month duration. Sessions take place in the same quiet room and they usually last 45 minutes each up to 1 hour depending on the patient's response. During sessions, the patient wearied a bathing suit. Sessions were conducted under the supervision of an occupational therapist and involved at least two members of the patient's care team.	Other: WET sheet Therapeutic body wraps; At the beginning of the session, the patient's consent to proceed was orally obtained, as no session was compulsory. The therapists checked behavioral manifestations of refusal. Then, the patient was first wrapped in wet damp sheets (cold phase) and covered up with a rescue and a dry blanket. Afterward the body spontaneously warmed up (warm phase). The patient was then invited to freely express his feelings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aberrant Behavior Checklist (ABC) irritability score	Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score Irritability of the scale ABC	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ABC hyperactivity score	Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score hyperactivity of the scale ABC	Baseline,1-month, 2-month and 3-months
ABC lethargy score	Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score lethargy of the scale ABC	Baseline,1-month, 2-month and 3-months
ABC inappropriate speech score	Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score inappropriate speech of the scale ABC	Baseline,1-month, 2-month and 3-months
ABC stereotypic behavior score	Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score stereotypic behavior of the scale ABC	Baseline,1-month, 2-month and 3-months
ABC Total score	Measure the reduction in the intensity of the behavioral disorders objectified by the total score of the scale ABC	Baseline,1-month, 2-month and 3-months
Child Autism Rating Scale (CARS)	Measure the decrease in the intensity of autistic symptoms	Baseline,1-month, 2-month and 3-months
Clinical Global Impression-Improvement (CGI-I)	Measure the global clinical outcome	Baseline,1-month, 2-month and 3-months
Clinical Global Impression-Severity (CGI-S)	Measure the global clinical outcome	Baseline,1-month, 2-month and 3-months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Pierre Delion, MD, PhD, University Hospital, Lille

Publications and helpful links

General Publications

• Huang HF, Tian JL, Yang XT, Sun L, Hu RY, Yan ZH, Li SS, Xie Q, Tian XB. Efficacy and safety of low-molecular-weight heparin after knee arthroscopy: A meta-analysis. PLoS One. 2018 Jun 21;13(6):e0197868. doi: 10.1371/journal.pone.0197868. eCollection 2018.
• Delion P, Labreuche J, Deplanque D, Cohen D, Duhamel A, Lallie C, Ravary M, Goeb JL, Medjkane F, Xavier J; Therapeutic Body Wrap Study group. Therapeutic body wraps (TBW) for treatment of severe injurious behaviour in children with autism spectrum disorder (ASD): A 3-month randomized controlled feasibility study. PLoS One. 2018 Jun 29;13(6):e0198726. doi: 10.1371/journal.pone.0198726. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Autism; Therapeutic body wraps
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: 2007/0715; 2007-A01376-47 (Other Identifier: ID-RCB number, ANSM); DGS 2008-0070 (Other Identifier: DGS number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No