Autism Spectrum DisorderPACKINGNCT03164746
Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism With Severe Injurious Behavior.
A study testing Dry sheet Therapeutic body wraps and WET sheet Therapeutic body wraps in people with Autism Spectrum Disorder, run by University Hospital, Lille at 13 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Dry sheet Therapeutic body wraps and WET sheet Therapeutic body wraps
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 13 sitesFrance
- Study dates
- Dec 2007to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Centre de Santé Mentale Angevin
Angers
Centre Hospitalier d'Arras
Arras
Centre Hospitalier Robert Ballanger
Aulnay-sous-Bois
Centre Hospitalier Montfavet
Avignon
Institut Départemental Albert Calmette
Camiers
Centre Hospitalier de Douai
Douai
Etablissement Public de Santé Roger Prévot
Gennevilliers
Centre Hospitalier de Lens
Lens
Hôpital Fontan, CHRU
Lille
Institut Médico-éducatif
Montigny-en-Ostrevent
Etablissement de Santé Maison Blanche
Paris
Groupe Hospitalier Pitier-Salpêtrière
Paris
Etablissement Public de Santé Mentale Val de Lys-Artois
Saint-Venant
About this study
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.
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Dry sheet Therapeutic body wraps, WET sheet Therapeutic body wraps
- Keywords
- Autism, Therapeutic body wraps
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry sheet Therapeutic body wrapsOther
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.
WET sheet Therapeutic body wrapsOther
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 group | Role | What they receive |
|---|---|---|
| DRY group | Active comparator | 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. Receives: Other: Dry sheet Therapeutic body wraps |
| WET Group | Experimental | 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. Receives: Other: WET sheet Therapeutic body wraps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist (ABC) irritability score
Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score Irritability of the scale ABC
Measured: Baseline and 3 months
Secondary outcomes (8)
ABC hyperactivity score
Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score hyperactivity of the scale ABC
Measured: Baseline,1-month, 2-month and 3-months
ABC lethargy score
Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score lethargy of the scale ABC
Measured: Baseline,1-month, 2-month and 3-months
ABC inappropriate speech score
Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score inappropriate speech of the scale ABC
Measured: Baseline,1-month, 2-month and 3-months
ABC stereotypic behavior score
Measure the reduction in the intensity of the behavioral disorders objectified by the sub-score stereotypic behavior of the scale ABC
Measured: Baseline,1-month, 2-month and 3-months
ABC Total score
Measure the reduction in the intensity of the behavioral disorders objectified by the total score of the scale ABC
Measured: Baseline,1-month, 2-month and 3-months
Child Autism Rating Scale (CARS)
Measure the decrease in the intensity of autistic symptoms
Measured: Baseline,1-month, 2-month and 3-months
Clinical Global Impression-Improvement (CGI-I)
Measure the global clinical outcome
Measured: Baseline,1-month, 2-month and 3-months
Clinical Global Impression-Severity (CGI-S)
Measure the global clinical outcome
Measured: Baseline,1-month, 2-month and 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startDec 2007
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Pierre Delion, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164746
- Sponsor's protocol ID
- 2007/0715
- Other IDs
- 2007-A01376-47, DGS 2008-0070
- Acronym
- PACKING
- Status last verified
- Apr 2026
- First submitted
- 22 May 2017
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Delion P, Labreuche J, Deplanque D, Cohen D, Duhamel A, Lallie C, Ravary M, Goeb JL, Medjkane F, Xavier J; Therapeutic Body Wrap Study group. Therapeutic body wraps (TBW) for treatment of severe injurious behaviour in children with autism spectrum disorder (ASD): A 3-month randomized controlled feasibility study. PLoS One. 2018 Jun 29;13(6):e0198726. doi: 10.1371/journal.pone.0198726. eCollection 2018.
PubMed 29958284Huang HF, Tian JL, Yang XT, Sun L, Hu RY, Yan ZH, Li SS, Xie Q, Tian XB. Efficacy and safety of low-molecular-weight heparin after knee arthroscopy: A meta-analysis. PLoS One. 2018 Jun 21;13(6):e0197868. doi: 10.1371/journal.pone.0197868. eCollection 2018.
PubMed 29927930
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03164746
- Acronym / sponsor ID
- PACKING / 2007/0715
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, Therapeutic body wraps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Dec 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRY group | Active comparator | Other: Dry sheet Therapeutic body wrapsDry 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. |
| WET Group | Experimental | Other: WET sheet Therapeutic body wrapsWet 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry sheet Therapeutic body wrapsAt 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 | DRY group |
| WET sheet Therapeutic body wrapsAt 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. | Other | WET Group |
Primary outcome
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
8 secondary outcomes
ABC hyperactivity score
Time frame: Baseline,1-month, 2-month and 3-months
ABC lethargy score
Time frame: Baseline,1-month, 2-month and 3-months
ABC inappropriate speech score
Time frame: Baseline,1-month, 2-month and 3-months
ABC stereotypic behavior score
Time frame: Baseline,1-month, 2-month and 3-months
ABC Total score
Time frame: Baseline,1-month, 2-month and 3-months
Child Autism Rating Scale (CARS)
Time frame: Baseline,1-month, 2-month and 3-months
Clinical Global Impression-Improvement (CGI-I)
Time frame: Baseline,1-month, 2-month and 3-months
Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline,1-month, 2-month and 3-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 29958284Delion P, Labreuche J, Deplanque D, Cohen D, Duhamel A, Lallie C, Ravary M, Goeb JL, Medjkane F, Xavier J; Therapeutic Body Wrap Study group. Therapeutic body wraps (TBW) for treatment of severe injurious behaviour in children with autism spectrum disorder (ASD): A 3-month randomized controlled feasibility study. PLoS One. 2018 Jun 29;13(6):e0198726. doi: 10.1371/journal.pone.0198726. eCollection 2018.
- Derived from this study: PubMed 29927930Huang HF, Tian JL, Yang XT, Sun L, Hu RY, Yan ZH, Li SS, Xie Q, Tian XB. Efficacy and safety of low-molecular-weight heparin after knee arthroscopy: A meta-analysis. PLoS One. 2018 Jun 21;13(6):e0197868. doi: 10.1371/journal.pone.0197868. eCollection 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Delion, MD, PhD principal investigator
University Hospital, Lille
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry sheet Therapeutic body wraps and WET sheet Therapeutic body wraps in people with Autism Spectrum Disorder, run by University Hospital, Lille at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist (ABC) irritability score (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164746, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.