AutismAUTISMNCT02154828
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
An observational study of Autism, run by Nantes University Hospital at 21 sites in France.
Trial summary
The research project is part of the evaluation of the therapeutic approaches in mental health. Its framework infant and juvenile units that have developed "integrative devices," taking into account recent advances in knowledge and providing care, education and pedagogical approach. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Autism
- What is being tested?
- Integrative practices
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 103 participants
- Where
- 21 sitesFrance
- Study dates
- Sep 2014to Mar 2018
- Phase
- Observational
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 3 to 6 years with a diagnosis F84.0 and F84.1 according to CIM-10, supported in care units that meet the criteria defined integrative practices.
Who may be able to join
- Children 3 to 6 years with diagnosis F84.0 and F84.1 according to ICD-10. The diagnosis should be made according to the criteria established by the recommendations on the diagnosis (FFP / HAS 2005).
- Children supported in care units that meet the criteria defined integrative practices.
- Children receiving a volume of hours of intervention between two and four half-days per week.
- Written parental consent collection.
Who cannot join
- Presence of co-morbidities such epilepsia, serious organ damage, somatic and sensory.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CHI Robert Ballanger
Aulnay-sous-Bois, 93600
Daumezon hospital
Bouguenais, 44340
Brest University Hospital
Brest, 29000
Brive Hospital
Brivé, 19312
CH du Vinatier
Bron, 69500
Inercomunal Center
Créteil, 94010
Fondation Vallée
Gentilly, 94250
CH Gonesse
Gonesse, 95500
HDJ Les Marmousets
Haguenau, 67500
ARSEAA - Centre de guidance
Labège, 31670
CH Saint-Marie
Le Puy-en-Velay, 43009
Lille University Hospital
Lille, 59037
EPSM de l'agglomération Lilloise
Mons-en-Barœul, 59370
Nantes University Hospital
Nantes, 44093
Niort Hospital
Niort, 79000
HDJ La Pomme
Paris, 75000
Hôpitaux de St Maurice
Paris, 75000
Unité de soins précoces HJ René Diatkine ASM13
Paris, 75000
Saint-Nazaire Hospital
Saint-Nazaire, 44600
Centre Hospitalier CESAME
Sainte-Gemmes-sur-Loire, 49130
Rouvray Hospital
Sotteville-lès-Rouen, 76301
About this study
The research project is part of the evaluation of the therapeutic approaches in mental health. Its framework infant and juvenile units that have developed "integrative devices," taking into account recent advances in knowledge and providing care, education and pedagogical approach. The evolution of autistic children receiving these integrative devices is studied to determine the validity of the devices mentioned. The methodology is based on case studies in a natural situation. Clinicians are committed to network among themselves and with researchers in a multicenter study.
- Conditions
- Autism
- Being tested
- Integrative practices
- Keywords
- Children, aged, 3 to 6 years
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative practicesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Integrative practices | Children included in this project are children 3 to 6 years with diagnosis F84.0 F84.1 according to CIM-10.
these children must be supported in care units that meet the criteria defined integrative practices. Receives: Behavioral: Integrative practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental evolution in the Psycho Educative-Profil 3 (PEP 3) scale between Month 0 and Month 12
The main objective is to evaluate scare practices in autism for children 3 to 6 years
Measured: Month 12 (score : success or failure or emergence)
Secondary outcomes (2)
Global evolution of children by ECA-R scale
Measured: Month 12 (score 0 to 4)
Global evolution thanks to CARS scale
Measured: Month 12 (score between 15 and 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole GARRET-GLOANEC, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154828
- Sponsor's protocol ID
- RC14_0029
- Acronym
- AUTISM
- Status last verified
- Dec 2018
- First submitted
- 15 Apr 2014
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bettencourt C, Garret-Gloanec N, Pellerin H, Pere M, Squillante M, Roos-Weil F, Ferrand L, Pernel AS, Apter G, Cohen D. Migration is associated with baseline severity and progress over time in autism spectrum disorder: Evidence from a French prospective longitudinal study. PLoS One. 2022 Oct 6;17(10):e0272693. doi: 10.1371/journal.pone.0272693. eCollection 2022.
PubMed 36201564
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
- ClinicalTrials.gov ID
- NCT02154828
- Acronym / sponsor ID
- AUTISM / RC14_0029
- Conditions
- Autism
- Keywords
- Children, aged, 3 to 6 years
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 3 Jun 2014 (estimated)
- 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.
The research project is part of the evaluation of the therapeutic approaches in mental health. Its framework infant and juvenile units that have developed "integrative devices," taking into account recent advances in knowledge and providing care, education and pedagogical approach. The evolution of autistic children receiving these integrative devices is studied to determine the validity of the devices mentioned. The methodology is based on case studies in a natural situation. Clinicians are committed to network among themselves and with researchers in a multicenter study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative practices | – | Behavioral: Integrative practicesChildren included in this project are children 3 to 6 years with diagnosis F84.0 F84.1 according to CIM-10. these children must be supported in care units that meet the criteria defined integrative practices. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 3 to 6 years with a diagnosis F84.0 and F84.1 according to CIM-10, supported in care units that meet the criteria defined integrative practices.
Key inclusion criteria (4 listed)
- Children 3 to 6 years with diagnosis F84.0 and F84.1 according to ICD-10. The diagnosis should be made according to the criteria established by the recommendations on the diagnosis (FFP / HAS 2005).
- Children supported in care units that meet the criteria defined integrative practices.
- Children receiving a volume of hours of intervention between two and four half-days per week.
- Written parental consent collection.
Key exclusion criteria (1 listed)
- Presence of co-morbidities such epilepsia, serious organ damage, somatic and sensory.
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 |
|---|---|---|
| Integrative practices | Behavioural | Integrative practices |
Primary outcome
Developmental evolution in the Psycho Educative-Profil 3 (PEP 3) scale between Month 0 and Month 12
Time frame: Month 12 (score : success or failure or emergence)
The main objective is to evaluate scare practices in autism for children 3 to 6 years
2 secondary outcomes
Global evolution of children by ECA-R scale
Time frame: Month 12 (score 0 to 4)
Global evolution thanks to CARS scale
Time frame: Month 12 (score between 15 and 60)
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 12 Dec 2018.
- Derived from this study: PubMed 36201564Bettencourt C, Garret-Gloanec N, Pellerin H, Pere M, Squillante M, Roos-Weil F, Ferrand L, Pernel AS, Apter G, Cohen D. Migration is associated with baseline severity and progress over time in autism spectrum disorder: Evidence from a French prospective longitudinal study. PLoS One. 2022 Oct 6;17(10):e0272693. doi: 10.1371/journal.pone.0272693. eCollection 2022.
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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.
Nicole GARRET-GLOANEC, PH principal investigator
Nantes University Hospital
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by Nantes University Hospital at 21 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 4 inclusion and 1 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 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Developmental evolution in the Psycho Educative-Profil 3 (PEP 3) scale between Month 0 and Month 12 (time frame: Month 12 (score : success or failure or emergence)). 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 NCT02154828, which also lists 1 linked publication.
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 12 Dec 2018.