Autism Spectrum DisorderMICHELANGELONCT02560415
Gaming Open Library for Intervention in Autism at Home (GOLIAH /MICHELANGELO)
A study testing Experimental and Comparator in people with Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH). Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Experimental and Comparator
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jun 2015
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a current diagnosis of ASD confirmed by clinical assessment and the Autism Diagnostic Interview-Revised;
- an intellectual quotient ≥ 60;
- aged between 5 to 8 years.
- Inclusion in the experimental group was based on parents' motivation to follow such a heavy protocol both at home and for the one session per week at the hospital.
- Controls were matched for sex, age, IQ, study sites and treatment.
Who cannot join
- known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities.
About this study
Official title: Patient-centric Model for Remote Management, Treatment and Rehabilitation of Children With Autism - Michelangelo / GOLIAH (Gaming Open Library for Intervention in Autism at Home) Project
To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH). The major objective of the study is to test GOLIAH during a 6-month matched controlled exploratory study were to assess (1) the usefulness and acceptability of the gaming platform; (2) how experimental children performed using the different Imitation and JA games; and (3) whether children from the experimental group improved significantly more than children treated as usual (control group).
Read the detailed description
Background: To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH) by mapping the Imitation and Joint Attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. For the purpose of this study, 24 ASD children will be recruited (one half in Pisa and the other half in Paris). They will be divided into two groups: an Experimental group (N=14) and a Control group (N=10). The Control group will not go through the training sessions, they will participate only in the assessment sessions. All patients will be referred to treatment as usual, according to local facilities.
The protocol is organized into 3 periods (with two assessments at T0 and T6).
- During the initial stage of the protocol (T0), all the ASD children (experimental participants and controls) will be evaluated during a clinical session.
- During the rehabilitation period, only half of the children will participate in the training sessions designed to improve their imitation and joint attention capacities.
- During the final stage of the protocol (T6), all children will be evaluated again during a second clinical session.
The clinical assessments will occur at stage 0 and at stage 6. The same tools will be used for these two assessments. The improvement of children's capabilities will be measured by the progress made between stage 0 and stage 6. The investigators will be able to affirm that the training was beneficial by comparing the clinical session performance between the trained and control children.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Experimental, Comparator
- Keywords
- Autism Spectrum Disorder, Serious Game, Controlled trial, Denver model
- 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.
ExperimentalDevice
Gaming Open Library for Intervention in Autism at Home plus Treatment as usual
ComparatorBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| 1: Experimental | Experimental | Gaming Open Library for Intervention in Autism at Home plus Treatment as usual Receives: Device: Experimental; Behavioral: Comparator |
| 2: Comparator | Active comparator | Treatment as usual Receives: Behavioral: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months
Measured: at baseline and 6 months
Secondary outcomes (5)
change from baseline in Vineland II at 6 months
Measured: at baseline and 6 months
change from baseline in Child Behavior Check List at 6 months
Measured: at baseline and 6 months
change from baseline in Wechsler Intelligence scale at 6 months
Measured: at baseline and 6 months
change from baseline in Social Communication Questionnaire at 6 months
Measured: at baseline and 6 months
change from baseline in Parental Stress Index at 6 months
Measured: at baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- David Cohen, MD, PhD, Principal investigator, Groupe hospitalier Pitié-Salpêtrière, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560415
- Sponsor's protocol ID
- IDRCB2014-A-00170-47 - P120914
- Other IDs
- EU: FP7-ICT-2011-7 (n°288241)
- Acronym
- MICHELANGELO
- Status last verified
- Sep 2015
- First submitted
- 21 Sep 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jouen AL, Narzisi A, Xavier J, Tilmont E, Bodeau N, Bono V, Ketem-Premel N, Anzalone S, Maharatna K, Chetouani M, Muratori F, Cohen D; MICHELANGELO Study Group. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study. Child Adolesc Psychiatry Ment Health. 2017 Mar 22;11:17. doi: 10.1186/s13034-017-0154-7. eCollection 2017.
PubMed 28344643Bono V, Narzisi A, Jouen AL, Tilmont E, Hommel S, Jamal W, Xavier J, Billeci L, Maharatna K, Wald M, Chetouani M, Cohen D, Muratori F; MICHELANGELO Study Group. GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. Front Psychiatry. 2016 Apr 28;7:70. doi: 10.3389/fpsyt.2016.00070. eCollection 2016.
PubMed 27199777
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centric Model for Remote Management, Treatment and Rehabilitation of Children With Autism - Michelangelo / GOLIAH (Gaming Open Library for Intervention in Autism at Home) Project
- ClinicalTrials.gov ID
- NCT02560415
- Acronym / sponsor ID
- MICHELANGELO / IDRCB2014-A-00170-47 - P120914
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Serious Game, Controlled trial, Denver model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Sep 2015 (estimated)
- 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.
To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH). The major objective of the study is to test GOLIAH during a 6-month matched controlled exploratory study were to assess (1) the usefulness and acceptability of the gaming platform; (2) how experimental children performed using the different Imitation and JA games; and (3) whether children from the experimental group improved significantly more than children treated as usual (control group).
Detailed description
Background: To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH) by mapping the Imitation and Joint Attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. For the purpose of this study, 24 ASD children will be recruited (one half in Pisa and the other half in Paris). They will be divided into two groups: an Experimental group (N=14) and a Control group (N=10). The Control group will not go through the training sessions, they will participate only in the assessment sessions. All patients will be referred to treatment as usual, according to local facilities.
The protocol is organized into 3 periods (with two assessments at T0 and T6).
- During the initial stage of the protocol (T0), all the ASD children (experimental participants and controls) will be evaluated during a clinical session.
- During the rehabilitation period, only half of the children will participate in the training sessions designed to improve their imitation and joint attention capacities.
- During the final stage of the protocol (T6), all children will be evaluated again during a second clinical session.
The clinical assessments will occur at stage 0 and at stage 6. The same tools will be used for these two assessments. The improvement of children's capabilities will be measured by the progress made between stage 0 and stage 6. The investigators will be able to affirm that the training was beneficial by comparing the clinical session performance between the trained and control children.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Experimental | Experimental | Device: Experimental, Behavioral: ComparatorGaming Open Library for Intervention in Autism at Home plus Treatment as usual |
| 2: Comparator | Active comparator | Behavioral: ComparatorTreatment as usual |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- a current diagnosis of ASD confirmed by clinical assessment and the Autism Diagnostic Interview-Revised;
- an intellectual quotient ≥ 60;
- aged between 5 to 8 years.
- Inclusion in the experimental group was based on parents' motivation to follow such a heavy protocol both at home and for the one session per week at the hospital.
- Controls were matched for sex, age, IQ, study sites and treatment.
Key exclusion criteria (1 listed)
- known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities.
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 |
|---|---|---|
| ExperimentalGaming Open Library for Intervention in Autism at Home plus Treatment as usual | Device | 1: Experimental |
| ComparatorTreatment as usual | Behavioural | 1: Experimental, 2: Comparator |
Primary outcome
change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months
Time frame: at baseline and 6 months
5 secondary outcomes
change from baseline in Vineland II at 6 months
Time frame: at baseline and 6 months
change from baseline in Child Behavior Check List at 6 months
Time frame: at baseline and 6 months
change from baseline in Wechsler Intelligence scale at 6 months
Time frame: at baseline and 6 months
change from baseline in Social Communication Questionnaire at 6 months
Time frame: at baseline and 6 months
change from baseline in Parental Stress Index at 6 months
Time frame: at baseline and 6 months
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 25 Sep 2015.
- Derived from this study: PubMed 28344643Jouen AL, Narzisi A, Xavier J, Tilmont E, Bodeau N, Bono V, Ketem-Premel N, Anzalone S, Maharatna K, Chetouani M, Muratori F, Cohen D; MICHELANGELO Study Group. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study. Child Adolesc Psychiatry Ment Health. 2017 Mar 22;11:17. doi: 10.1186/s13034-017-0154-7. eCollection 2017.
- Derived from this study: PubMed 27199777Bono V, Narzisi A, Jouen AL, Tilmont E, Hommel S, Jamal W, Xavier J, Billeci L, Maharatna K, Wald M, Chetouani M, Cohen D, Muratori F; MICHELANGELO Study Group. GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. Front Psychiatry. 2016 Apr 28;7:70. doi: 10.3389/fpsyt.2016.00070. eCollection 2016.
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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.
David Cohen, MD, PhD principal investigator
Groupe hospitalier Pitié-Salpêtrière, Paris, France
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and Comparator in people with Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris.
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 5 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 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months (time frame: at baseline and 6 months). 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 NCT02560415, 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 25 Sep 2015.