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Completed

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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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHI Robert Ballanger, Aulnay-sous-Bois, France

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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

Integrative practices

Behavioral

Primary outcomes

  1. 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

  1. Global evolution of children by ECA-R scale

    Time frame: Month 12 (score 0 to 4)

  2. Global evolution thanks to CARS scale

    Time frame: Month 12 (score between 15 and 60)

Sponsors and collaborators

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.

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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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