Clinical trial NCT03164746: Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism With Severe Injurious Behavior.
Official title: Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Therapeutic body wraps
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2017-05-24
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aberrant Behavior Checklist (ABC) irritability score
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: ABC hyperactivity score
timeFrame: Baseline,1-month, 2-month and 3-months
measure: ABC lethargy score
timeFrame: Baseline,1-month, 2-month and 3-months
measure: ABC inappropriate speech score
timeFrame: Baseline,1-month, 2-month and 3-months
measure: ABC stereotypic behavior score
timeFrame: Baseline,1-month, 2-month and 3-months
measure: ABC Total score
timeFrame: Baseline,1-month, 2-month and 3-months
measure: Child Autism Rating Scale (CARS)
timeFrame: Baseline,1-month, 2-month and 3-months
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: Baseline,1-month, 2-month and 3-months
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: Baseline,1-month, 2-month and 3-months
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre de Santé Mentale Angevin
city: Arras
country: France
facility: Centre Hospitalier d'Arras
city: Aulnay-sous-Bois
country: France
facility: Centre Hospitalier Robert Ballanger
city: Avignon
country: France
facility: Centre Hospitalier Montfavet
city: Camiers
country: France
facility: Institut Départemental Albert Calmette
city: Douai
country: France
facility: Centre Hospitalier de Douai
city: Gennevilliers
country: France
facility: Etablissement Public de Santé Roger Prévot
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Lille
country: France
facility: Hôpital Fontan, CHRU
city: Montigny-en-Ostrevent
country: France
facility: Institut Médico-éducatif
city: Paris
country: France
facility: Etablissement de Santé Maison Blanche
city: Paris
country: France
facility: Groupe Hospitalier Pitier-Salpêtrière
city: Saint-Venant
country: France
facility: Etablissement Public de Santé Mentale Val de Lys-Artois
Study officials:
affiliation: University Hospital, Lille
name: Pierre Delion, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.