NCT02444117

Brief Summary

This study aims to identify clinical and biological markers which would allow to evaluate precisely the evolution of children with autism spectrum disorders throughout intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

6 years

First QC Date

February 18, 2015

Last Update Submit

November 2, 2022

Conditions

Autistic Disorder

Keywords

neurophysiology

Outcome Measures

Primary Outcomes (1)

  • Clinical changes between Baseline and Two years

    Autism Diagnostic Observation Schedule (ADOS)

    2 years

Secondary Outcomes (9)

  • neurophysiological evaluations at baseline

    baseline

  • neurophysiological evaluations at 1 year

    1 year

  • neurophysiological évaluations at 2 years

    2 years

  • Social and cognitive evaluations at baseline

    baseline

  • Social and cognitive évaluations at 1 year

    1 year

  • +4 more secondary outcomes

Interventions

functional rehabilitation of social communicationOTHER

Eligibility Criteria

Age12 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with autism spectrum disorders

You may qualify if:

  • re-education of social communication

You may not qualify if:

  • multi-handicapped associated to ASD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Tours

Tours, 37000, France

Location

Related Publications (1)

  • Khanna RK, Kovarski K, Arsene S, Siwiaszczyk M, Pisella PJ, Bonnet-Brilhault F, Batty M, Malvy J. Ophthalmological findings in children with autism spectrum disorder. Graefes Arch Clin Exp Ophthalmol. 2020 Apr;258(4):909-916. doi: 10.1007/s00417-019-04594-7. Epub 2020 Jan 9.

    PMID: 31919663DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Joelle Malvy, MD, PhD

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2015

First Posted

May 14, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

FR(1)