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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03164746
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE May 22, 2017
First Posted Date  ICMJE May 24, 2017
Last Update Posted Date May 24, 2017
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
Aberrant Behavior Checklist (ABC) irritability score [ Time Frame: Baseline and 3 months ]
Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score Irritability of the scale ABC
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • ABC hyperactivity score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Baseline,1-month, 2-month and 3-months ]
    Measure the decrease in the intensity of autistic symptoms
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Baseline,1-month, 2-month and 3-months ]
    Measure the global clinical outcome
  • Clinical Global Impression-Severity (CGI-S) [ Time Frame: Baseline,1-month, 2-month and 3-months ]
    Measure the global clinical outcome
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism With Severe Injurious Behavior.
Official Title  ICMJE Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • Other: Dry sheet Therapeutic body wraps
    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.
  • Other: WET sheet Therapeutic body wraps
    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.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Other: Dry sheet Therapeutic body wraps
  • Experimental: 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.
    Intervention: Other: WET sheet Therapeutic body wraps
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2017)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03164746
Other Study ID Numbers  ICMJE 2007/0715
2007-A01376-47 ( Other Identifier: ID-RCB number, ANSM )
DGS 2008-0070 ( Other Identifier: DGS number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Pierre Delion, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP