NCT02154828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

2.3 years

First QC Date

April 15, 2014

Last Update Submit

December 11, 2018

Conditions

Autism

Keywords

Childrenaged3 to 6 years

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Global evolution of children by ECA-R scale

    Month 12 (score 0 to 4)

  • Global evolution thanks to CARS scale

    Month 12 (score between 15 and 60)

Study Arms (1)

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

Interventions

Integrative practicesBEHAVIORAL
Integrative practices

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of co-morbidities such epilepsia, serious organ damage, somatic and sensory.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

CHI Robert Ballanger

Aulnay-sous-Bois, 93600, France

Location

Daumezon hospital

Bouguenais, 44340, France

Location

Brest University Hospital

Brest, 29000, France

Location

Brive Hospital

Brivé, 19312, France

Location

CH du Vinatier

Bron, 69500, France

Location

Inercomunal Center

Créteil, 94010, France

Location

Fondation Vallée

Gentilly, 94250, France

Location

CH Gonesse

Gonesse, 95500, France

Location

HDJ Les Marmousets

Haguenau, 67500, France

Location

ARSEAA - Centre de guidance

Labège, 31670, France

Location

CH Saint-Marie

Le Puy-en-Velay, 43009, France

Location

Lille University Hospital

Lille, 59037, France

Location

EPSM de l'agglomération Lilloise

Mons-en-Barœul, 59370, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Niort Hospital

Niort, 79000, France

Location

HDJ La Pomme

Paris, 75000, France

Location

Hôpitaux de St Maurice

Paris, 75000, France

Location

Unité de soins précoces HJ René Diatkine ASM13

Paris, 75000, France

Location

Saint-Nazaire Hospital

Saint-Nazaire, 44600, France

Location

Centre Hospitalier CESAME

Sainte-Gemmes-sur-Loire, 49130, France

Location

Rouvray Hospital

Sotteville-lès-Rouen, 76301, France

Location

Related Publications (1)

  • Bettencourt C, Garret-Gloanec N, Pellerin H, Pere M, Squillante M, Roos-Weil F, Ferrand L, Pernel AS, Apter G, Cohen D. Migration is associated with baseline severity and progress over time in autism spectrum disorder: Evidence from a French prospective longitudinal study. PLoS One. 2022 Oct 6;17(10):e0272693. doi: 10.1371/journal.pone.0272693. eCollection 2022.

    PMID: 36201564DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nicole GARRET-GLOANEC, PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

June 3, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2016

Study Completion

March 1, 2018

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

FR(21)