AutismIDEA2SCOLANCT03924973
3 Year Follow up Study of the IDEA Population
A study testing ESDM followed by treatment as usual in people with Autism, run by Hôpital le Vinatier at 1 site in France.
Trial summary
The aim of this study is to assess the efficiency of early treatment for ASD children 5 years after initial treatment. The early treatment implemented was 12 hours per week of ESDM versus treatment as usual during 2 years. This was done as an RCT, called IDEA. Read more about this study
- Who is it for?
- Ages 39 to 60 months
- Conditions the study is for
- Autism
- What is being tested?
- ESDM followed by treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2019to 31 Dec 2023
- 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 39 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Requiring less than 40 minutes travel to the assessment center
Who cannot join
- Impossibility of coming in for assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Efficacy of Early Intervention With Early Start Denver Model (ESDM) on the Severity of Autism
The aim of this study is to assess the efficiency of early treatment for ASD children 5 years after initial treatment.
The early treatment implemented was 12 hours per week of ESDM versus treatment as usual during 2 years. This was done as an RCT, called IDEA. Children will now be included in IDEA-2 SCOLA, a three year follow up study.
Read the detailed description
180 children with ASD, younger than 3 years old, were included in the IDEA RCT. Children were allocated to the ESDM treatment group or the treatment as usual group. The aim of IDEA-2 is to follow-up this population for 3 years after the initial 2 years of intervention, that is, 5 years after initial inclusion to IDEA.
Investigators hypothesize that children who received ESDM 12 hours per week will have a significant decrease of autism symptoms and will have a better scholastic level 5 years after initial inclusion to IDEA.
- Conditions
- Autism
- Being tested
- ESDM followed by treatment as usual
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESDM followed by treatment as usualBehavioural
Also called Treatment as usual delivered in the community
The intervention was ESDM, delivered by professionals, one therapist per child, 12 hours per week during 2 years.
Then, they will receive the treatment as usual during 3 years in this current follow-up study.
Precise description of the 2 years ESDM treatment can be found in the published protocol of IDEA.
What is called "treatment as usual" is what the community can usually offer. That is what the control group in IDEA received.
In IDEA-2, both control and interventional group of IDEA will receive treatment as usual during 3 years.
Treatment as usual comprises of different types of interventions, such as speech pathology therapy, occupational therapy and other types of therapy more or less specific to ASD in the community.
All the interventions received by the children will be monitored in IDEA-2. All different treatment approaches will be quantified (type, frequency, intensity and duration).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Children below the age of 3 in this group received 2 years of ESDM intervention for 12 hours per week, and then treatment as usual for the 3 following years.
What is called "treatment as usual" is what the community can usually offer. That is what the control group in IDEA received.
In IDEA-2, both control and interventional group of IDEA will receive treatment as usual during 3 years.
Treatment as usual comprises of different types of interventions, such as speech pathology therapy, occupational therapy and other types of therapy more or less specific to ASD in the community. Receives: Behavioral: ESDM followed by treatment as usual |
| Control group | Other | Children in this group received treatment as usual delivered in the community for the 2 years of IDEA.
Participants will still receive treatment as usual delivered in the community during IDEA-2, in the 3 years following IDEA. Receives: Behavioral: ESDM followed by treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADOS (Autism Diagnostic Observation Schedule )
Autism Diagnostic Observation Schedule is a semi-structured, standardized, observational tool, which measures core autism symptoms, that is to say reciprocal sociocommunicative interaction, and repetitive and restrictive behaviors. This assessment will be administered by an assessor blind to the allocation group.
Measured: 3 YEARS
Secondary outcomes (4)
Wechsler (Wechsler Intelligence Scale for Children)
The WISC-IV, the Wechsler Intelligence Scale for Children and Adolescents - 4th Edition - measures total IQ as well as 4 indices: verbal comprehension, perceptual reasoning, processing speed and working memory. It is for children aged 6 to 16 and lasts 60 to 90 minutes.
The WPPSI-R or the Revised Wechsler Primary and Preschool Intelligence Scale is a psychometric test for very young children, for children from 2 to 6 years old The scores of standard items are between 7 and 13 for the average, if they are less than 4, the child is very deficient in this item.
3 years after the beginning of the follow-up study ( i.e. 5 years after initial inclusion to IDEA
Measured: 3 YEARS
VABS (Vineland Adaptive Behavior Scales)
The items refer to the age of the person: the first items correspond to the simplest tasks that even a small child should know how to do, and at the end of the scale are grouped the most complex tasks.
In the field of communication: items range from 1 to 67.Depending on the standard score obtained, five adaptive levels can be defined:top, moderately High, adequate, moderately low, low Daily adaptive skills measured by the composite score from the Vineland Adaptive Behavior Scales ( VABS) 3 years after the beginning of the follow-up study ( i.e. 5 years after initial inclusion to IDEA
Measured: 3 YEARS
PPVT ( Peabody Picture Vocabulary Test )
Receptive language skills measured by Peabody Picture Vocabulary Test (PPVT)3 years after the beginning of the follow-up study ( i.e. 5 years after initial inclusion to IDEA
Measured: 3 YEARS
Parental self-assentiment
Scholastic skills and interventions measured by Parental self-assentiment
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start17 Apr 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- single blind
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GEOFFRAY MARIE-MAUDE, PH, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924973
- Sponsor's protocol ID
- 2017-A02446-47
- Acronym
- IDEA2SCOLA
- Status last verified
- Mar 2025
- First submitted
- 19 Apr 2019
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Early Intervention With Early Start Denver Model (ESDM) on the Severity of Autism
- ClinicalTrials.gov ID
- NCT03924973
- Acronym / sponsor ID
- IDEA2SCOLA / 2017-A02446-47
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Apr 2019 (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 aim of this study is to assess the efficiency of early treatment for ASD children 5 years after initial treatment.
The early treatment implemented was 12 hours per week of ESDM versus treatment as usual during 2 years. This was done as an RCT, called IDEA. Children will now be included in IDEA-2 SCOLA, a three year follow up study.
Detailed description
180 children with ASD, younger than 3 years old, were included in the IDEA RCT. Children were allocated to the ESDM treatment group or the treatment as usual group. The aim of IDEA-2 is to follow-up this population for 3 years after the initial 2 years of intervention, that is, 5 years after initial inclusion to IDEA.
Investigators hypothesize that children who received ESDM 12 hours per week will have a significant decrease of autism symptoms and will have a better scholastic level 5 years after initial inclusion to IDEA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single blind
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: ESDM followed by treatment as usualChildren below the age of 3 in this group received 2 years of ESDM intervention for 12 hours per week, and then treatment as usual for the 3 following years. What is called "treatment as usual" is what the community can usually offer. That is what the control group in IDEA received. In IDEA-2, both control and interventional group of IDEA will receive treatment as usual during 3 years. Treatment as usual comprises of different types of interventions, such as speech pathology therapy, occupational therapy and other types of therapy more or less specific to ASD in the community. |
| Control group | Other | Behavioral: ESDM followed by treatment as usualChildren in this group received treatment as usual delivered in the community for the 2 years of IDEA. Participants will still receive treatment as usual delivered in the community during IDEA-2, in the 3 years following IDEA. |
Who may qualify
- Ages
- 39 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Requiring less than 40 minutes travel to the assessment center
Key exclusion criteria (1 listed)
- Impossibility of coming in for assessment
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 |
|---|---|---|
| ESDM followed by treatment as usualAlso: Treatment as usual delivered in the communityThe intervention was ESDM, delivered by professionals, one therapist per child, 12 hours per week during 2 years. Then, they will receive the treatment as usual during 3 years in this current follow-up study. Precise description of the 2 years ESDM treatment can be found in the published protocol of IDEA. What is called "treatment as usual" is what the community can usually offer. That is what the control group in IDEA received. In IDEA-2, both control and interventional group of IDEA will receive treatment as usual during 3 years. Treatment as usual comprises of different types of interventions, such as speech pathology therapy, occupational therapy and other types of therapy more or less specific to ASD in the community. All the interventions received by the children will be monitored in IDEA-2. All different treatment approaches will be quantified (type, frequency, intensity and duration). | Behavioural | Control group, Experimental group |
Primary outcome
ADOS (Autism Diagnostic Observation Schedule )
Time frame: 3 YEARS
Autism Diagnostic Observation Schedule is a semi-structured, standardized, observational tool, which measures core autism symptoms, that is to say reciprocal sociocommunicative interaction, and repetitive and restrictive behaviors. This assessment will be administered by an assessor blind to the allocation group.
4 secondary outcomes
Wechsler (Wechsler Intelligence Scale for Children)
Time frame: 3 YEARS
VABS (Vineland Adaptive Behavior Scales)
Time frame: 3 YEARS
PPVT ( Peabody Picture Vocabulary Test )
Time frame: 3 YEARS
Parental self-assentiment
Time frame: 3 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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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, PH principal investigator
CH 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 ESDM followed by treatment as usual in people with Autism, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ADOS (Autism Diagnostic Observation Schedule ) (time frame: 3 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 Mar 2025.