Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism With Severe Injurious Behavior.
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): Dry sheet Therapeutic body wraps; WET sheet Therapeutic body wraps
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Autism; Therapeutic body wraps