Autism Spectrum DisorderPEGASENCT03769571
Generalized Training Program for Caregivers on the ESDM: PEGASE
A study testing Parental coaching program at ESDM (P-ESDM) in people with Autism Spectrum Disorder, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The main objective of the study is to evaluate the effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Parental coaching program at ESDM (P-ESDM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2018to 7 Nov 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to 4 years
- Child diagnosed with the clinical criteria of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and International Classification of Diseases 10th Revision (ICD 10). Initial diagnosis of Autism spectrum disorder (ASD) should be validated by recommended diagnostic scales: ADI R, ADOS 2.
- A child whose parents or legal representatives have accepted their child's participation in this study, and have signed informed consent.
Who cannot join
- No presentation to initial and final evaluations
- Withdrawal of informed consent (which can intervene at any time of the study and without proof)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de pédopsychiatrie Sainte-Marguerite
Marseille, Marseille Cedex 09, 13274
Clarisse Chatel, PH, 0491745771, clarisse.chatel@ap-hm.fr
About this study
Official title: Generalized Training Program for Caregivers on the ESDM
The main objective of the study is to evaluate the effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.
This study is follow up by the Autism Resource Center PACA (CRA PACA), which is located in Marseille's university Department of Child Psychiatry.
Read more
This center is a regional expert center in diagnostic and research missions in the field of Autism. The center is promoting new advances in the field of Autism Spectrum Disorders (ASD) The center receives requests for diagnostic assessment from all the region. Autism is to date a major public health problem, current prevalence rates are 1 child / 88 in the United States. This prevalence continues to increase.
Autism is a severe neurodevelopment disorder with significant functional impact.
An essential axis in the field of health is to develop new treatment strategy including low costs and family impact particularly in quality of life.
In France, consensus guidelines (HAS 2012) on the diagnosis assessment for Autism Spectrum Disorders (ASD) people and interventions were edited.
Support for grade recommendations have been issued. In this research, the investigators focus on a global, early and coordinated management method: the Early Start Denver Model. This intervention obtained a grade B to the recommendations of the HAS in 2012. Early Start Denver Model (ESDM) is scientifically proven by a lots of studies.
Two management modalities are discuss in the ESDM model: the classical ESDM and the ESDM P (parents ESDM). Even if in both ways of care, the parent is put in a central position around the care of the child. In P ESDM, the parent is trained in the techniques of ESDM itself. This parental coaching program at ESDM (P-ESDM) was developed by Rogers et al at Sacramento Davis University.
P ESDM is not yet developed in France and has not been the subject of any French-language publication to date.
This program is dedicated to young parents of children with autism spectrum disorders aged between 2 and 4 years old.
This is a 7-month program (with a duration of inclusion of 3 year). The program is based on ESDM techniques, it meets both the need to include parents in care and the idea of reducing the cost of these care (need fewer hours of care by professionals).
This program is offered to all parents of autism spectrum disorders children between the ages of 2 and 4 who go to CRA PACA for an expert diagnostic evaluation.
The aim of this study is to objectify the effectiveness of this parental intervention in a French population.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Parental coaching program at ESDM (P-ESDM)
- 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.
Parental coaching program at ESDM (P-ESDM)Behavioural
It will have a duration of 7 months (with an inclusion period of 1 year). Parents will come to the hospital with their child once every 15 days for one-hour parental coaching sessions on the ESDM method. Home video sessions will also be performed by parents once every 15 days. Each parent will have a Certified therapist referral to the practice of ESDM and the program is framed by a certified therapist and trained in ESDM parental coaching.
| Study group | Role | What they receive |
|---|---|---|
| parental coaching program at ESDM (P-ESDM) | Other | Not described Receives: Behavioral: Parental coaching program at ESDM (P-ESDM) |
| CONTROL | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.
Autism Diagnostic Observation Schedule 2 (ADOS 2) : Assessment of social affect and restricted and repetitive behaviours, autism severity level/Selected module
The scale is between 0 and 3 :
- Note 0 is assigned when the behavior does not show abnormalities specific to the disorders invasive development;
- Note 1 is assigned when the behaviour is slightly abnormal or slightly unusual;
- Note 2 corresponds to a clearly abnormal behaviour;
- Note 3 is attributed to a frankly abnormal behavior, to the point that it interferes with the interaction. This note may also correspond to such a limited behaviour as the assessment of its quality social security is impossible.
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start8 Nov 2018
- Primary completion7 Nov 2021 (estimated)
- Study completion7 Nov 2021 (estimated)
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 Assistance Publique Hopitaux De MarseilleThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Olivier Arnaud, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769571
- Sponsor's protocol ID
- 2018-42
- Acronym
- PEGASE
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2018
- Last updated
- 10 Dec 2018
- 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 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalized Training Program for Caregivers on the ESDM
- ClinicalTrials.gov ID
- NCT03769571
- Acronym / sponsor ID
- PEGASE / 2018-42
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 7 Nov 2021 (estimated)
- Study completion
- 7 Nov 2021 (estimated)
- First posted
- 7 Dec 2018 (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 main objective of the study is to evaluate the effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.
This study is follow up by the Autism Resource Center PACA (CRA PACA), which is located in Marseille's university Department of Child Psychiatry.
This center is a regional expert center in diagnostic and research missions in the field of Autism. The center is promoting new advances in the field of Autism Spectrum Disorders (ASD) The center receives requests for diagnostic assessment from all the region. Autism is to date a major public health problem, current prevalence rates are 1 child / 88 in the United States. This prevalence continues to increase.
Autism is a severe neurodevelopment disorder with significant functional impact.
An essential axis in the field of health is to develop new treatment strategy including low costs and family impact particularly in quality of life.
In France, consensus guidelines (HAS 2012) on the diagnosis assessment for Autism Spectrum Disorders (ASD) people and interventions were edited.
Support for grade recommendations have been issued. In this research, the investigators focus on a global, early and coordinated management method: the Early Start Denver Model. This intervention obtained a grade B to the recommendations of the HAS in 2012. Early Start Denver Model (ESDM) is scientifically proven by a lots of studies.
Two management modalities are discuss in the ESDM model: the classical ESDM and the ESDM P (parents ESDM). Even if in both ways of care, the parent is put in a central position around the care of the child. In P ESDM, the parent is trained in the techniques of ESDM itself. This parental coaching program at ESDM (P-ESDM) was developed by Rogers et al at Sacramento Davis University.
P ESDM is not yet developed in France and has not been the subject of any French-language publication to date.
This program is dedicated to young parents of children with autism spectrum disorders aged between 2 and 4 years old.
This is a 7-month program (with a duration of inclusion of 3 year). The program is based on ESDM techniques, it meets both the need to include parents in care and the idea of reducing the cost of these care (need fewer hours of care by professionals).
This program is offered to all parents of autism spectrum disorders children between the ages of 2 and 4 who go to CRA PACA for an expert diagnostic evaluation.
The aim of this study is to objectify the effectiveness of this parental intervention in a French population.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parental coaching program at ESDM (P-ESDM) | Other | Behavioral: Parental coaching program at ESDM (P-ESDM) |
| CONTROL | No intervention | – |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 2 to 4 years
- Child diagnosed with the clinical criteria of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and International Classification of Diseases 10th Revision (ICD 10). Initial diagnosis of Autism spectrum disorder (ASD) should be validated by recommended diagnostic scales: ADI R, ADOS 2.
- A child whose parents or legal representatives have accepted their child's participation in this study, and have signed informed consent.
Key exclusion criteria (2 listed)
- No presentation to initial and final evaluations
- Withdrawal of informed consent (which can intervene at any time of the study and without proof)
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 |
|---|---|---|
| Parental coaching program at ESDM (P-ESDM)It will have a duration of 7 months (with an inclusion period of 1 year). Parents will come to the hospital with their child once every 15 days for one-hour parental coaching sessions on the ESDM method. Home video sessions will also be performed by parents once every 15 days. Each parent will have a Certified therapist referral to the practice of ESDM and the program is framed by a certified therapist and trained in ESDM parental coaching. | Behavioural | parental coaching program at ESDM (P-ESDM) |
Primary outcome
effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.
Time frame: 7 month
Autism Diagnostic Observation Schedule 2 (ADOS 2) : Assessment of social affect and restricted and repetitive behaviours, autism severity level/Selected module The scale is between 0 and 3 : * Note 0 is assigned when the behavior does not show abnormalities specific to the disorders invasive development; * Note 1 is assigned when the behaviour is slightly abnormal or slightly unusual; * Note 2 corresponds to a clearly abnormal behaviour; * Note 3 is attributed to a frankly abnormal behavior, to the point that it interferes with the interaction. This note may also correspond to such a limited behaviour as the assessment of its quality social security is impossible.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
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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.
Jean Olivier Arnaud, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental coaching program at ESDM (P-ESDM) in people with Autism Spectrum Disorder, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Dec 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clarisse Chatel, PH (4 91 74 57 71 ext. + 33, clarisse.chatel@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders. (time frame: 7 month). 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 10 Dec 2018.