Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism With Severe Injurious Behavior.
- Conditions
- Autism Spectrum Disorder
- Interventions
- Other: WET sheet Therapeutic body wrapsOther: Dry sheet Therapeutic body wraps
- Registration Number
- NCT03164746
- Lead Sponsor
- University Hospital, Lille
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WET Group WET sheet Therapeutic body wraps 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. DRY group Dry sheet Therapeutic body wraps 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.
- Primary Outcome Measures
Name Time Method Aberrant Behavior Checklist (ABC) irritability score Baseline and 3 months Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score Irritability of the scale ABC
- Secondary Outcome Measures
Name Time Method ABC hyperactivity score Baseline,1-month, 2-month and 3-months Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score hyperactivity of the scale ABC
ABC lethargy score Baseline,1-month, 2-month and 3-months Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score lethargy of the scale ABC
ABC inappropriate speech score Baseline,1-month, 2-month and 3-months Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score inappropriate speech of the scale ABC
ABC stereotypic behavior score Baseline,1-month, 2-month and 3-months Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score stereotypic behavior of the scale ABC
ABC Total score Baseline,1-month, 2-month and 3-months Measure the reduction in the intensity of the behavioral disorders objectified by the total score of the scale ABC
Child Autism Rating Scale (CARS) Baseline,1-month, 2-month and 3-months Measure the decrease in the intensity of autistic symptoms
Clinical Global Impression-Improvement (CGI-I) Baseline,1-month, 2-month and 3-months Measure the global clinical outcome
Clinical Global Impression-Severity (CGI-S) Baseline,1-month, 2-month and 3-months Measure the global clinical outcome
Trial Locations
- Locations (13)
Centre de Santé Mentale Angevin
🇫🇷Angers, France
Centre Hospitalier d'Arras
🇫🇷Arras, France
Etablissement de Santé Maison Blanche
🇫🇷Paris, 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
Centre Hospitalier Robert Ballanger
🇫🇷Aulnay-sous-Bois, France
Centre Hospitalier Montfavet
🇫🇷Avignon, France
Institut Départemental Albert Calmette
🇫🇷Camiers, France
Etablissement Public de Santé Mentale Val de Lys-Artois
🇫🇷Saint-Venant, France
Groupe Hospitalier Pitier-Salpêtrière
🇫🇷Paris, France
Centre Hospitalier de Douai
🇫🇷Douai, France