CompletedNot Applicable

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

France48 participantsStarted 2007-12

Plain-language 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.

Who can participate

Age range5 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Aberrant Behavior Checklist (ABC) irritability score

Timeframe: Baseline and 3 months

Trial details

NCT IDNCT03164746

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12