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

Autism Spectrum Disorder Clinical Trial

— PACKING  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164746
• Other study ID #: 2007/0715
• Secondary ID: 2007-A01376-47DG
• Status: Completed
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 22, 2017
• Start date: December 2007
• Est. completion date: December 2014

Study information

• Verified date: May 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Child Autism Rating Scale (CARS)	Measure the decrease in the intensity of autistic symptoms	Baseline,1-month, 2-month and 3-months
Secondary	Clinical Global Impression-Improvement (CGI-I)	Measure the global clinical outcome	Baseline,1-month, 2-month and 3-months
Secondary	Clinical Global Impression-Severity (CGI-S)	Measure the global clinical outcome	Baseline,1-month, 2-month and 3-months