NCT Number: NCT02154828
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
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.
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Notify MeKey information
Conditions
Age range
3 year–6 year
Sex eligibility
All sexes
Study type
Observational
Primary location
CHI Robert Ballanger, Aulnay-sous-Bois, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
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 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)
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Lead sponsor
Nantes University Hospital
Other
Registry information
Acronym: AUTISM
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2018
- First posted
- Jun 3, 2014
- Registry last updated
- Dec 12, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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