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

December 11, 2018 updated by: Nantes University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aulnay sous bois, France, 93600
        • Chi Robert Ballanger
      • Bouguenais, France, 44340
        • Daumezon hospital
      • Brest, France, 29000
        • Brest University Hospital
      • Brive, France, 19312
        • Brive Hospital
      • Bron, France, 69500
        • CH du Vinatier
      • Créteil, France, 94010
        • Inercomunal Center
      • Gentilly, France, 94250
        • Fondation Vallée
      • Gonesse, France, 95500
        • CH Gonesse
      • Haguenau, France, 67500
        • HDJ Les Marmousets
      • Labege, France, 31670
        • ARSEAA - Centre de guidance
      • Le Puy-en-Velay, France, 43009
        • CH Saint-Marie
      • Lille, France, 59037
        • Lille University Hospital
      • Mons en Baroeul, France, 59370
        • EPSM de l'agglomération Lilloise
      • Nantes, France, 44093
        • Nantes University Hospital
      • Niort, France, 79000
        • Niort Hospital
      • Paris, France, 75000
        • HDJ La Pomme
      • Paris, France, 75000
        • Hôpitaux de St Maurice
      • Paris, France, 75000
        • Unité de soins précoces HJ René Diatkine ASM13
      • Saint-Nazaire, France, 44600
        • Saint-Nazaire Hospital
      • Sainte-Gemmes sur Loire, France, 49130
        • Centre Hospitalier CESAME
      • Sotteville les Rouen, France, 76301
        • Rouvray Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children 3 to 6 years with a diagnosis F84.0 and F84.1 according to CIM-10, supported in care units that meet the criteria defined integrative practices.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: Integrative practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 12 (score : success or failure or emergence)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Nicole GARRET-GLOANEC, PH, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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