Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

Completed

• Conditions: Autism
• Interventions: Behavioral: Integrative practices

• Registration Number: NCT02154828
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Study Start: 2014-09
• Primary Completion: 2016-12
• Study Completion: 2018-03
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Integrative practices	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.

Primary Outcome Measures

Name	Time	Method
Developmental evolution in the Psycho Educative-Profil 3 (PEP 3) scale between Month 0 and Month 12	Month 12 (score : success or failure or emergence)	The main objective is to evaluate scare practices in autism for children 3 to 6 years

Secondary Outcome Measures

Name	Time	Method
Global evolution thanks to CARS scale	Month 12 (score between 15 and 60)
Global evolution of children by ECA-R scale	Month 12 (score 0 to 4)

Trial Locations

Locations (21)

Daumezon hospital; 🇫🇷 Bouguenais, France

Brive Hospital; 🇫🇷 Brive, France

Inercomunal Center; 🇫🇷 Créteil, France

Brest University Hospital; 🇫🇷 Brest, France

CH du Vinatier; 🇫🇷 Bron, France

ARSEAA - Centre de guidance; 🇫🇷 Labege, France

Fondation Vallée; 🇫🇷 Gentilly, France

CH Gonesse; 🇫🇷 Gonesse, France

CH Saint-Marie; 🇫🇷 Le Puy-en-Velay, France

Lille University Hospital; 🇫🇷 Lille, France

EPSM de l'agglomération Lilloise; 🇫🇷 Mons en Baroeul, France

Nantes University Hospital; 🇫🇷 Nantes, France

Niort Hospital; 🇫🇷 Niort, France

Unité de soins précoces HJ René Diatkine ASM13; 🇫🇷 Paris, France

Hôpitaux de St Maurice; 🇫🇷 Paris, France

HDJ La Pomme; 🇫🇷 Paris, France

Saint-Nazaire Hospital; 🇫🇷 Saint-Nazaire, France

Centre Hospitalier CESAME; 🇫🇷 Sainte-Gemmes sur Loire, France

CHI Robert Ballanger; 🇫🇷 Aulnay sous bois, France

HDJ Les Marmousets; 🇫🇷 Haguenau, France

Rouvray Hospital; 🇫🇷 Sotteville les Rouen, France