Autism Spectrum DisorderNCT02996708
Assessment of the Benefit of Teleconsultations for Children With Autism Spectrum Disorders
An observational study of Autism Spectrum Disorder and Child Autism, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
Trial summary
The purpose of this study is to determine whether Teleconsultation would a)be effective and cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having a correct follow-up, and less transportation, and b) get a high satisfaction from the parents and from the professionals Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Child Autism
- How many people
- 102 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2014to Dec 2017
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Residents of medico-social structure accepting children and adolescent with autism disorders
Who may be able to join
- All residents of medico-social structures accepting children and adolescent with autism disorders
Who cannot join
- Refusal of parents that their child use telemedicine
- Refusal of parents that their child participate to the research
Trial locations and contacts
6 sites in 1 country.
Isabelle Durand-Zaleski, MD, PhD contact
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
IME notre Ecole
Carrières-sous-Poissy, 78955
Amélie Couteau
- Recruiting
Association Agir et Vivre l'Autisme
Chambourcy, 78240
Stéphane Da
- Recruiting
IME Eclair
Collégien, 77090
Liora CRESPIN
- Recruiting
Association UNI-TEDS
Dammarie-les-Lys, 77190
Slimane Haddadi
- Recruiting
Hôpital Sainte Anne
Paris, 75014
Catherine Doyen, MD, c.doyen@ch-sainte-anne.fr
- Recruiting
IME Le Reverdi
Vert-Saint-Denis, 77240
Christine CARNIAC
About this study
The purpose of this study is to determine whether Teleconsultation would a)be effective and cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having a correct follow-up, and less transportation, and b) get a high satisfaction from the parents and from the professionals
- Conditions
- Autism Spectrum Disorder, Child Autism
- Keywords
- Telemedicine, Health economics
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group with teleconsultation - before period | Not described | |
| Group without teleconsultation - before period | Not described | |
| Group with teleconsultation - after period | Not described | |
| Group without teleconsultation - after period | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score: CARS, VABS evaluated once a year and ADI-R at least once in the lifetime
Score equals 1 if all three evaluations are performed, 0 otherwise
Measured: One year after the start of the "before" period and one year after the start of the "after" period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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 - 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Doyen, MD, Principal investigator, Hôpital Sainte Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996708
- Sponsor's protocol ID
- TLM Prometted
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Benefit of Teleconsultations for Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02996708
- Acronym / sponsor ID
- TLM Prometted
- Conditions
- Autism Spectrum Disorder, Child Autism
- Keywords
- Telemedicine, Health economics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Dec 2016 (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.
The purpose of this study is to determine whether Teleconsultation would a)be effective and cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having a correct follow-up, and less transportation, and b) get a high satisfaction from the parents and from the professionals
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group with teleconsultation - before period | – | – |
| Group without teleconsultation - before period | – | – |
| Group with teleconsultation - after period | – | – |
| Group without teleconsultation - after period | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Residents of medico-social structure accepting children and adolescent with autism disorders
Key inclusion criteria (1 listed)
- All residents of medico-social structures accepting children and adolescent with autism disorders
Key exclusion criteria (2 listed)
- Refusal of parents that their child use telemedicine
- Refusal of parents that their child participate to the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite score: CARS, VABS evaluated once a year and ADI-R at least once in the lifetime
Time frame: One year after the start of the "before" period and one year after the start of the "after" period
Score equals 1 if all three evaluations are performed, 0 otherwise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Isabelle Durand-Zaleski, MD, PhD contact
Catherine Doyen, MD principal investigator
Hôpital Sainte Anne
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Child Autism, run by Assistance Publique - Hôpitaux de Paris at 6 sites 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 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 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Isabelle Durand-Zaleski, MD, PhD (isabelle.durand-zaleski@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite score: CARS, VABS evaluated once a year and ADI-R at least once in the lifetime (time frame: One year after the start of the "before" period and one year after the start of the "after" period). 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 19 Dec 2016.