Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 13
- 主要终点
- Aberrant Behavior Checklist (ABC) irritability score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
DRY group
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.
干预措施: Dry sheet Therapeutic body wraps (Other)
WET Group
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.
干预措施: WET sheet Therapeutic body wraps (Other)
结局指标
主要结局
Aberrant Behavior Checklist (ABC) irritability score
时间窗: Baseline and 3 months
Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score Irritability of the scale ABC
次要结局
- ABC hyperactivity score(Baseline,1-month, 2-month and 3-months)
- ABC Total score(Baseline,1-month, 2-month and 3-months)
- ABC lethargy score(Baseline,1-month, 2-month and 3-months)
- ABC inappropriate speech score(Baseline,1-month, 2-month and 3-months)
- ABC stereotypic behavior score(Baseline,1-month, 2-month and 3-months)
- Child Autism Rating Scale (CARS)(Baseline,1-month, 2-month and 3-months)
- Clinical Global Impression-Improvement (CGI-I)(Baseline,1-month, 2-month and 3-months)
- Clinical Global Impression-Severity (CGI-S)(Baseline,1-month, 2-month and 3-months)