An interventional study of Early Start Denver Model and 'as-usual' intervention in Autism Spectrum Disorder, sponsored by Hôpital le Vinatier. Terminated at 1 site in France. Open to participants aged 15 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Treatment
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Among 110 studies in Autism Spectrum Disorder with a site in France — 51 open to participants now, 55 under way, 2 of them phase 3. Autism Spectrum Disorder · France.
Among the 110 studies in Autism Spectrum Disorder with a site in France, this one is the 77th largest by enrollment of the 77 interventional ones that give a count, is the only one that started in 2017, is one of 58 with no phase, and was the 29th registered.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →51 of the 110 studies in Autism Spectrum Disorder with a site in France are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in France, United States, Germany and 7 more countries
Ages 5–17
Hopital La Musse · Sites in France
Ages 15–17 · Healthy volunteers
Hospices Civils de Lyon · Sites in France
Ages 5–50
Fondation FondaMental · Sites in France
Ages 15–60 · Healthy volunteers
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 8–16
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 298 take children under 18; 92 take healthy volunteers.
This study: 15 Months to 36 Months · all sexes · healthy volunteers too.
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110 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 12 · Phase 3 9
First in 2007; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1 is below the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.
Median enrollment 70 across the 77 interventional studies, 120 across the 33 observational. Of the 43 that completed or were terminated, 8 (19%) have results posted.
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8 of 110 have an industry lead sponsor. The 10 most frequent:
Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
Hôpital le Vinatier has 8 studies filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
17 of the studies in Autism Spectrum Disorder with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07655115Phase 3Hospital General Universitario Gregorio MarañonSingle Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th | 2026-12-31 |
| NCT06871696Institut National de la Santé Et de la Recherche Médicale, FranceGenetic of Intellectual Deficiency and Autism Spectrum Disorders (RaDiCo-GenIDA) | 2026-11 |
| NCT05512637University Hospital, MontpellierScreening for Neurodevelopmental Disorders in Siblings of Children With Autism Diagnosed in Tertiary Centers | 2026-11 |
| NCT04638452Centre Hospitalier Charles Perrens, BordeauxEvaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice | 2026-11-30 |
| NCT05864508University Hospital, ToulouseInterest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study. | 2026-12 |
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Among the 110 studies in Autism Spectrum Disorder with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The Early start Denver model (Rogers, 2010; Dawson, 2010) is a developmental and behavioral model that aim to enhance socio-comunicative abilities and also global development of children with Autism spectrum disorder (ASD). The purpose of this study is to identify changes in neurocognitive profile of children population with ASD receiving Early Start Denver Model (ESDM) applied 12 hours per week in comparison to children receiving other interventions. That is a study proposed to children with ASD and their families that participate already to a randomized control study called IDEA registered on clinicaltrials.gov NCT02608333.
the investigators hypothesized that ESDM would increase social cognition, reduce shifting attention time and increase preference for unpredictable stimuli.
IDEA is a multicenter (4 centers in France and 1 center in Belgium), randomized, controlled, single blind trial using a modified Zelen design .It concerns children with ASD aged 15 to 36 months without severe neurological or physical disorder and living in the proximity of one the early intervention units. After diagnostic, Children will be included in a longitudinal cohort with the consent of the parents. Sixty children will be drawn lots among 180 children of the cohort and will be included in an ESDM intervention with the consent of the parents. Two groups will be compared: an experimental group of 60 children receiving 12 hours a week of ESDM intervention delivered by trained therapists during 2 years and a control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period. In IDEA development of communication and social interactions and global developmental of all the children will be measured at different time points (at baseline (t0), after 1 year (t1), after 2 years( t2)) over the two years through standardized tests such as Autism diagnostic observation Schedule (ADOS-2), Mullen Scales of Early Learning (MSEL) and the Vineland Adaptive Behavior Scale (VABS-2).
Children will be included in this second study called IDEA-EYE with parents' consent. Then, preference for biological motion and social scene, shifting attention time and preference for sameness will be measure in both groups with an Eye-tracker Tobii TX 300 at t0,t1 and t2. These measures will also be collected in a group of children without ASD at t0,t1 and t2.
the investigators expect, as primary criteria, a significant superior time spend on biological motion in ESDM group versus control group after 2 years of treatment. the investigators also expect a significant superior orientation toward eyes in complex social scenes, an inferior shifting attention time and a superior preference for unpredictable stimuli in ESDM group versus ASD control group after 2 years. the investigators also expect that ESDM group would have time spend on biological motion, orientation toward eyes in complex scenes, shifting attention time and preference for unpredictable stimuli comparable to children without ASD after 2 years.
This study would allow better understanding of ESDM active principles.
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Exclusion Criteria:
an experimental group of 60 children receiving 12 hours a week of Early Start Denver Model (ESDM) intervention delivered by trained therapists during 2 years ESDM is a comprehensive relational, developmental and behavioral intervention.It's described in a manual for Professional and parents.
Behavioral: Early Start Denver Model
a control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period.
Behavioral: 'as-usual' intervention
ESDM is a comprehensive relational, developmental and behavioral intervention. It's described in a manual for professional (Rogers et al, 2010). Children receive ESDM at minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.
a control group receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period.
The primary outcome will be the time spent on biological motion in the task of visual preference stimuli.
2 different types of stimuli (dynamic biological or geometrical movements) are presented in parallel on each part of the screen alternatively (left and/ or right). Child sit at 60 cm from the screen of the Eye-tracker can look towards the one or the other one stimuli.
Time frame: 2 years
Average proximity from pattern eyes norm in complex social scene task
A 3-minute cartoon is displayed on a Tobii TX 300 eye-tracker. Inspired by the concept of a heatmap, for each frame of the video "normative" gaze pattern distribution are created by employing kernel density distribution estimation on the raw gaze data of TD individuals (Botev et al., 2009). For each patient we then will calculate the "distance" of his/hers gaze coordinates from this "norm". Thus we will obtain one measure per frame of Proximity from the "norm", which will be then averaged for the duration of the video.
Time frame: 2 years
Difference of saccadic latencies between overlap and gap condition
in a gap/ overlap paradigm displayed on the Tobii TX 300 eye-tracker screen, we will measure the difference of mean of saccadic latencies between the two conditions.
Time frame: 2 years
Time spent on unpredictable stimuli
2 type of stimuli are presented on the Eye-tracker screen : one very predictable stimuli and unpredictable stimuli.
Time frame: 2 years
Ran from May 2017 to primary completion in Mar 2022, 57 months.
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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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