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

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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

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: Dry sheet Therapeutic body wraps Other: WET sheet Therapeutic body wraps Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.
Study Start Date : December 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Child Autism Rating Scale (CARS) [ Time Frame: Baseline,1-month, 2-month and 3-months ]
    Measure the decrease in the intensity of autistic symptoms

  7. Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Baseline,1-month, 2-month and 3-months ]
    Measure the global clinical outcome

  8. Clinical Global Impression-Severity (CGI-S) [ Time Frame: Baseline,1-month, 2-month and 3-months ]
    Measure the global clinical outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164746


Locations
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France
Centre de Santé Mentale Angevin
Angers, France
Centre Hospitalier d'Arras
Arras, France
Centre Hospitalier Robert Ballanger
Aulnay-sous-Bois, France
Centre Hospitalier Montfavet
Avignon, France
Institut Départemental Albert Calmette
Camiers, France
Centre Hospitalier de Douai
Douai, 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
Etablissement de Santé Maison Blanche
Paris, France
Groupe Hospitalier Pitier-Salpêtrière
Paris, France
Etablissement Public de Santé Mentale Val de Lys-Artois
Saint-Venant, France
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Pierre Delion, MD, PhD University Hospital, Lille

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03164746     History of Changes
Other Study ID Numbers: 2007/0715
2007-A01376-47 ( Other Identifier: ID-RCB number, ANSM )
DGS 2008-0070 ( Other Identifier: DGS number )
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Autism
Therapeutic body wraps
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders