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

Autism Clinical Trial

— AUTISM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154828
• Other study ID #: RC14_0029
• Status: Completed
• Start date: September 2014
• Est. completion date: March 2018

Study information

• Verified date: December 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Behavioral:
• Integrative practices

Locations

Country	Name	City	State
France	CHI Robert Ballanger	Aulnay sous bois
France	Daumezon hospital	Bouguenais
France	Brest University Hospital	Brest
France	Brive Hospital	Brive
France	CH du Vinatier	Bron
France	Inercomunal Center	Créteil
France	Fondation Vallée	Gentilly
France	CH Gonesse	Gonesse
France	HDJ Les Marmousets	Haguenau
France	ARSEAA - Centre de guidance	Labege
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	HDJ La Pomme	Paris
France	Hôpitaux de St Maurice	Paris
France	Unité de soins précoces HJ René Diatkine ASM13	Paris
France	Saint-Nazaire Hospital	Saint-Nazaire
France	Centre Hospitalier CESAME	Sainte-Gemmes sur Loire
France	Rouvray Hospital	Sotteville les Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Month 12 (score : success or failure or emergence)
Secondary	Global evolution of children by ECA-R scale		Month 12 (score 0 to 4)
Secondary	Global evolution thanks to CARS scale		Month 12 (score between 15 and 60)