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Clinical Trials/NCT02154828
NCT02154828
Completed
Not Applicable

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

Nantes University Hospital21 sites in 1 country103 target enrollmentSeptember 2014
ConditionsAutism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Nantes University Hospital
Enrollment
103
Locations
21
Primary Endpoint
Developmental evolution in the Psycho Educative-Profil 3 (PEP 3) scale between Month 0 and Month 12
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
March 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children 3 to 6 years with diagnosis F84.0 and F84.1 according to ICD-
  • 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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))

Study Sites (21)

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