Clinical trial NCT02154828: Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
Official title: Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism
Keywords: Children
aged
3 to 6 years
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 103
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Presence of co-morbidities such epilepsia, serious organ damage, somatic and sensory.

Primary outcomes:
measure: Developmental evolution in the Psycho Educative-Profil 3 (PEP 3) scale between Month 0 and Month 12
timeFrame: Month 12 (score : success or failure or emergence)
Secondary outcomes:
measure: Global evolution of children by ECA-R scale
timeFrame: Month 12 (score 0 to 4)
measure: Global evolution thanks to CARS scale
timeFrame: Month 12 (score between 15 and 60)
Other outcomes:
Locations:
city: Aulnay sous bois
country: France
facility: CHI Robert Ballanger
city: Bouguenais
country: France
facility: Daumezon hospital
city: Brest
country: France
facility: Brest University Hospital
city: Brive
country: France
facility: Brive Hospital
city: Bron
country: France
facility: CH du Vinatier
city: Créteil
country: France
facility: Inercomunal Center
city: Gentilly
country: France
facility: Fondation Vallée
city: Gonesse
country: France
facility: CH Gonesse
city: Haguenau
country: France
facility: HDJ Les Marmousets
city: Labege
country: France
facility: ARSEAA - Centre de guidance
city: Le Puy-en-Velay
country: France
facility: CH Saint-Marie
city: Lille
country: France
facility: Lille University Hospital
city: Mons en Baroeul
country: France
facility: EPSM de l'agglomération Lilloise
city: Nantes
country: France
facility: Nantes University Hospital
city: Niort
country: France
facility: Niort Hospital
city: Paris
country: France
facility: HDJ La Pomme
city: Paris
country: France
facility: Hôpitaux de St Maurice
city: Paris
country: France
facility: Unité de soins précoces HJ René Diatkine ASM13
city: Saint-Nazaire
country: France
facility: Saint-Nazaire Hospital
city: Sainte-Gemmes sur Loire
country: France
facility: Centre Hospitalier CESAME
city: Sotteville les Rouen
country: France
facility: Rouvray Hospital
Study officials:
affiliation: Nantes University Hospital
name: Nicole GARRET-GLOANEC, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.