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

NCT03164746 | Completed DMC

• 3 other identifiers: 2007/07152007-A01376-47DGS 2008-0070
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; Therapeutic body wraps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• ABC hyperactivity score

  Baseline,1-month, 2-month and 3-months

• ABC lethargy score

  Baseline,1-month, 2-month and 3-months

• ABC inappropriate speech score

  Baseline,1-month, 2-month and 3-months

• ABC stereotypic behavior score

  Baseline,1-month, 2-month and 3-months

• ABC Total score

  Baseline,1-month, 2-month and 3-months

Study Arms (2)

DRY group

ACTIVE COMPARATOR

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

WET Group

EXPERIMENTAL

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

Interventions

Dry sheet Therapeutic body wraps OTHER

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.

DRY group

WET sheet Therapeutic body wraps OTHER

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.

WET Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (13)

Centre de Santé Mentale Angevin

Angers, France

Location

Centre Hospitalier d'Arras

Arras, France

Location

Centre Hospitalier Robert Ballanger

Aulnay-sous-Bois, France

Location

Centre Hospitalier Montfavet

Avignon, France

Location

Institut Départemental Albert Calmette

Camiers, France

Location

Centre Hospitalier de Douai

Douai, France

Location

Etablissement Public de Santé Roger Prévot

Gennevilliers, France

Location

Centre Hospitalier de Lens

Lens, France

Location

Hôpital Fontan, CHRU

Lille, France

Location

Institut Médico-éducatif

Montigny-en-Ostrevent, France

Location

Etablissement de Santé Maison Blanche

Paris, France

Location

Groupe Hospitalier Pitier-Salpêtrière

Paris, France

Location

Etablissement Public de Santé Mentale Val de Lys-Artois

Saint-Venant, France

Location

Related Publications (2)

• 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.

  PMID: 29958284 RESULT

• 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.

  PMID: 29927930 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Pierre Delion, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: December 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (13)