治疗性身体包裹（TBW）治疗自闭症谱系障碍（ASD）儿童严重伤害行为：一项为期 3 个月的随机对照可行性研究。
Therapeutic body wraps (TBW) for treatment of severe injurious behaviour in children with autism spectrum disorder (ASD): A 3-month randomized controlled feasibility study.
机构信息
Département de Psychiatrie de l'Enfant et de l'Adolescent, Centre Hospitalier Universitaire de Lille, Lille, France.
Université de Lille, Centre Hospitalier Universitaire de Lille, Equipe d'Accueil A2694-Santé publique: épidémiologie et qualité des soins, Lille, France.
出版信息
PLoS One. 2018 Jun 29;13(6):e0198726. doi: 10.1371/journal.pone.0198726. eCollection 2018.
INTRODUCTION
The use of therapeutic body wraps (TBW) has been reported in small series or case reports, but has become controversial.
OBJECTIVES
This is a feasibility, multicentre, randomized, controlled, open-label trial with blinded outcome assessment (PROBE design).
SETTING
Children with autism and severe-injurious behaviours (SIB) were enrolled from 13 specialized clinics.
INTERVENTIONS
Dry-sheet TBW (DRY group) vs. wet-sheet TBW (WET group).
PRIMARY OUTCOME MEASURES
3-month change in the Aberrant Behaviour Checklist irritability score (ABC-irritability) within per-protocol (PP) sample.
RESULTS
From January 2008 to January 2015, we recruited 48 children (age range: 5.9 to 9.9 years, 78.1% male). Seven patients (4 in the DRY group, 3 in the WET group) were dropped from the study early and were excluded from PP analysis. At endpoint, ABC-irritability significantly improved in both groups (means (standard deviation) = -11.15 (8.05) in the DRY group and -10.57 (9.29) in the WET group), as did the other ABC scores and the Children Autism Rating scale score. However, there was no significant difference between groups. All but 5 patients were rated as much or very much improved. A repeated-measures analysis confirmed the significant improvement in ABC-irritability scores according to time (p < .0001), with no significant difference between the two groups (group effect: p = .55; interaction time x group: p = .27). Pooling both groups together, the mean 3-month change from baseline in ABC-irritability score was -10.90 (effect size = 1.59, p < .0001).
CONCLUSIONS
We found that feasibility was overall satisfactory with a slow recruitment rate and a rather good attrition rate. TBW was a safe complementary therapy in this population. There was no difference between wet and dry TBW at 3 months, and ABC-irritability significantly decreased with both wet and dry sheet TBW. To assess whether TBW may constitute an alternative to medication or behavioural intervention for treating SIB in ASD patients, a larger randomized comparative trial (e.g. TBW vs. antipsychotics) is warranted.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03164746.
简介
治疗性身体包裹（TBW）的使用已在小系列或病例报告中报道，但已引起争议。
目的
这是一项可行性、多中心、随机、对照、开放标签、结局评估盲法（PROBE 设计）试验。
设置
从 13 个专门诊所招募自闭症和严重伤害行为（SIB）的儿童。
干预措施
干片 TBW（DRY 组）与湿片 TBW（WET 组）。
主要结局测量
在符合方案（PP）样本中，3 个月时异常行为检查表烦躁评分（ABC-irritability）的变化。
结果
从 2008 年 1 月至 2015 年 1 月，我们招募了 48 名儿童（年龄范围：5.9 至 9.9 岁，78.1%为男性）。7 名患者（DRY 组 4 名，WET 组 3 名）提前退出研究并被排除在 PP 分析之外。在终点时，两组的 ABC-irritability 均显著改善（DRY 组平均值（标准差）为-11.15（8.05），WET 组为-10.57（9.29）），其他 ABC 评分和儿童自闭症评定量表评分也是如此。然而，两组之间没有显著差异。除 5 名患者外，其余患者均被评为明显或非常明显改善。重复测量分析证实，根据时间 ABC-irritability 评分显著改善（p<0.0001），两组间无显著差异（组效应：p=0.55；时间 x 组交互作用：p=0.27）。将两组合并，ABC-irritability 评分从基线的 3 个月平均变化为-10.90（效应量=1.59，p<0.0001）。
结论
我们发现，尽管招募速度较慢且脱落率较高，但总体而言，可行性令人满意。TBW 是该人群中一种安全的补充治疗方法。在 3 个月时，湿 TBW 和干 TBW 之间没有差异，湿和干 TBW 均显著降低 ABC-irritability。为了评估 TBW 是否可以替代 ASD 患者的药物治疗或行为干预来治疗 SIB，需要进行更大的随机对照试验（例如，TBW 与抗精神病药）。
试验注册
ClinicalTrials.gov NCT03164746。
Zotero 插件