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Autism Spectrum DisorderIDEANCT02608333

Efficiency of Early Intervention for Autism Spectrum Disorder

A study testing ESDM-12 in people with Autism Spectrum Disorder, run by Hôpital le Vinatier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intervention for autism spectrum disorder (ASD) in European French-speaking countries is often heterogeneous and poorly evaluated. Six French-speaking early intervention units for children with ASD following the Early Start Denver Model (ESDM) have been created since 2011 with the common aim to evaluate effectiveness… Read more about this study

Who is it for?
Ages 15 to 36 months
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
ESDM-12
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteFrance
Study dates
9 Sep 2015to 30 Jun 2021
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
  • No healthy volunteers
  • Child

Who may be able to join

  • Children 15 months to 36 months
  • Children with autism spectrum disorder (according to international criteria and standardized tests)
  • Children at a DQ of 30 at least at the MSEL
  • Family domiciled within 40 minutes of a early intervention unit (investigator center for the study)

Who cannot join

  • Severe neurological or physical disorder identified not allowing intensive care
  • Unavailability of the family for regular monitoring of the child by the investigator center
  • Rett Syndrom

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Vinatier

    Bron, AURA, 69678 cedex

Other trials in France

About this study

Official title: Impact of Early Intervention on the Global Development of Children With Autism Spectrum Disorder in a European French-speaking Population Dr Marie-Maude GEOFFRAY Le Vinatier Hospital

Intervention for autism spectrum disorder (ASD) in European French-speaking countries is often heterogeneous and poorly evaluated. Six French-speaking early intervention units for children with ASD following the Early Start Denver Model (ESDM) have been created since 2011 with the common aim to evaluate effectiveness and cost-efficiency of the ESDM applied to the European French-speaking public health system. In those units, Children receive ESDM at minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.

The first aim of the investigators study is to evaluate the effectiveness of ESDM intervention 12 hours per week during 2 years on the global development of children with ASD compared to the interventions commonly available in the community.

Read the detailed description

This is a multicenter (4 centers in France, 1 center in Switzerland and 1 center in Belgium), randomized, controlled, single blind trial using a modified Zelen design .It concerns children with ASD aged 18 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 a 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. Global developmental profiles of all the children will be measured at different time points over the two years through standardized tests such as the Mullen Scale of Early Learning (MSEL), the ADOS-2 and the Vineland Adaptive Behavior Scale. Cost of each intervention will be calculated.

The primary outcome is global development of the child, measured by the developmental quotient with the Mullen after 24 months of intervention.

Being tested
ESDM-12, control group
Keywords
Early intervention, ESDM, behavioral and developmental intervention
Medical subject headings
Autism Spectrum Disorder, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ESDM-12Behavioural

    Also called Early Start Denver Model 12 hours per week

    ESDM is a comprehensive relational, developmental and behavioral intervention. It's described in a manual for professional (Rogers et al, 2010).

    Children receive ESDM 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.

  • control groupBehavioural

    heteregenous "as usual "community intervention

Study groups in NCT02608333
Study groupRoleWhat they receive
ESDM-12ExperimentalESDM -12 : 60 children will receive 12 hours a week of ESDM ( Early Start Denver Model)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: ESDM-12
Control groupActive comparatorcontrol group: 120 children will receive heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period
Receives: Behavioral: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Developmental quotient at the Mullen Scale of Early Learning

    This criterion will be assessed with the Mullen scale of Early Learning (Mullen, 1995) by a psychologist blind of intervention group of the child:

    Measured: Change from baseline in developmental quotient at 24 months follow-up

Secondary outcomes (8)

  1. Severity of autism symptoms is measured with ADOS 2

    severity of autism symptoms is measured with ADOS 2 ( Autism Diagnostic observation Schedule 2)

    Measured: Change from baseline in severity score of autism symptoms at 24 months follow-up

  2. Adaptive behavior score is measured by the composite score of Vineland adaptative behavior scale 2

    Adaptative behavior score is measured by the composite score of Vineland adaptative behavior scale 2

    Measured: Change from baseline in adaptative behavior at 24 months follow-up

  3. Productive language level assessed with a standardized French productive language developmental scale

    This criterion will be assessed with a standardized French productive language developmental scale (DLPF "Development du language de production" in French language) filled by parents

    Measured: change from baseline in number of words at 24 months follow-up (T2)

  4. Costs associated with interventions

    Healthcare, social and personal resources devoted to child care throughout the study will be measured to evaluate the direct and indirect costs associated with intervention. Assessment will take place

    Measured: at 24 months follow-up (T2)

  5. Developement of communication and symbolic behavior

    Total score of Communication and Symbolic Behaviour Scale Developmental Profil CSBS-DP questionnaire for caregivers (Wetherby et al, 2002)

    Measured: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up

  6. Parent child naturalistic interaction during play

    Dyadic Communication Measure for Autism (DCMA)(Green et al, 2010; Pickles, 2015) will be used and score of parent's communication synchrony, child initiation, and shared attention will be assessed

    Measured: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2)

  7. Sensorial profil

    Sensorial profil of Dunn

    Measured: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2)

  8. Change at the Brief Observation of Social Communication Change (BOSCC)

    The total score of Brief Observation of Social Communication Change

    Measured: At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2015 (estimated)
  2. Study start9 Sep 2015
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02608333
Sponsor's protocol ID
2015-A00124-45
Acronym
IDEA
Status last verified
Feb 2021
First submitted
11 May 2015
Last updated
9 Jul 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Geoffray MM, Oreve MJ, Jurek L, Sonie S, Schroder C, Delvenne V, Manificat S, Touzet S, Agathe J, Mengarelli F, Natacha G, Petit N, Speranza M, Bahrami S, Bouveret L, Dochez SL, Auphan P, Zelmar A, Falissard B, Carlier S, Nourredine M, Denis A, Febvey-Combes O. Early Start Denver Model effectiveness in young autistic children: a large multicentric randomised controlled trial in two European countries. BMJ Ment Health. 2025 Jun 5;28(1):e301424. doi: 10.1136/bmjment-2024-301424.

    PubMed 40473417

  • Touzet S, Occelli P, Schroder C, Manificat S, Gicquel L, Stanciu R, Schaer M, Oreve MJ, Speranza M, Denis A, Zelmar A, Falissard B, Georgieff N, Bahrami S, Geoffray MM; IDEA Study Group. Impact of the Early Start Denver Model on the cognitive level of children with autism spectrum disorder: study protocol for a randomised controlled trial using a two-stage Zelen design. BMJ Open. 2017 Mar 27;7(3):e014730. doi: 10.1136/bmjopen-2016-014730.

    PubMed 28348195

Questions about this trial

What is this clinical trial studying?

A study testing ESDM-12 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 3 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 9 Jul 2021. 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?

Developmental quotient at the Mullen Scale of Early Learning (time frame: Change from baseline in developmental quotient at 24 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02608333, which also lists 2 linked publications.

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 9 Jul 2021.

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