Autism Spectrum DisorderIDEAEYENCT03254264
Impact of Early Interventions on Neurocognitive Profile of Children With Autism Spectrum Disorder
A study testing Early Start Denver Model and 'as-usual' intervention in people with Autism Spectrum Disorder, run by Hôpital le Vinatier at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 15 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Early Start Denver Model and 'as-usual' intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2017to 25 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 15 months to 36 months
- Children with autism spectrum disorder (according to international criteria, ADI and ADOS)
- DQ at 30 at least at the Early Learning Mullen Scale
- Family domiciled within 40 minutes of an early intervention unit
Who cannot join
- Severe neurological or physical disorder identified in the child or family that would interfere with intervention
- Unavailability of the family for regular monitoring of the child by the investigator center
- Child with a Rett Sd or Childhood disintegrative disorders
- Visual problems or with eyes in general
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Early Intervention on Neurocognitive Profile of Children With Autism Spectrum Disorder
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.
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Early Start Denver Model, 'as-usual' intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Start Denver ModelBehavioural
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.
'as-usual' interventionBehavioural
a control group receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period.
| Study group | Role | What they receive |
|---|---|---|
| ESDM-12 | Experimental | 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. Receives: Behavioral: Early Start Denver Model |
| Control group | Active comparator | a control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period. Receives: Behavioral: 'as-usual' intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start29 May 2017
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Why it stopped: one inclusion and not others
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GEOFFRAY Marie-Maude, PHD, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254264
- Sponsor's protocol ID
- 2015-A00696-43
- Acronym
- IDEAEYE
- Status last verified
- Mar 2022
- First submitted
- 16 Aug 2017
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Intervention on Neurocognitive Profile of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03254264
- Acronym / sponsor ID
- IDEAEYE / 2015-A00696-43
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: one inclusion and not others
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ESDM-12 | Experimental | Behavioral: Early Start Denver Modelan 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. |
| Control group | Active comparator | Behavioral: 'as-usual' interventiona control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period. |
Who may qualify
- Ages
- 15 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 15 months to 36 months
- Children with autism spectrum disorder (according to international criteria, ADI and ADOS)
- DQ at 30 at least at the Early Learning Mullen Scale
- Family domiciled within 40 minutes of an early intervention unit
Key exclusion criteria (4 listed)
- Severe neurological or physical disorder identified in the child or family that would interfere with intervention
- Unavailability of the family for regular monitoring of the child by the investigator center
- Child with a Rett Sd or Childhood disintegrative disorders
- Visual problems or with eyes in general
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Start Denver ModelESDM 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. | Behavioural | ESDM-12 |
| 'as-usual' interventiona control group receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period. | Behavioural | Control group |
Primary outcome
The primary outcome will be the time spent on biological motion in the task of visual preference stimuli.
Time frame: 2 years
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.
3 secondary outcomes
Average proximity from pattern eyes norm in complex social scene task
Time frame: 2 years
Difference of saccadic latencies between overlap and gap condition
Time frame: 2 years
Time spent on unpredictable stimuli
Time frame: 2 years
Results and safety
The study was stopped early (reason given: one inclusion and not others). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GEOFFRAY Marie-Maude, PHD principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Start Denver Model and 'as-usual' intervention in people with Autism Spectrum Disorder, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: one inclusion and not others). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the time spent on biological motion in the task of visual preference stimuli. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.